Petroleum Waxes and Related Products: Product Dossier No. 99/110

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product dossier no.

99/110

petroleum waxes and


related products
Prepared by CONCAWE’s Petroleum Products and Health Management Groups
with contribution by the European Wax Federation (EWF).

Reproduction permitted with due acknowledgement

 CONCAWE
Brussels
December 1999

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product dossier no. 99/110

ABSTRACT

The dossier summarizes the physical and chemical properties and toxicological,
health, safety and environmental information available on waxes and related
products. These include the slack waxes, petroleum waxes and petrolatum.

KEYWORDS

Petroleum wax, paraffin wax, slack wax, microcrystalline wax, petrolatum, toxicity,
ecotoxicity, health, environment, review.

NOTE

Considerable efforts have been made to assure the accuracy and reliability of the
information contained in this publication. However, neither CONCAWE nor any
company participating in CONCAWE can accept liability for any loss, damage or
injury whatsoever resulting from the use of this information.

This report does not necessarily represent the views of any company participating in
CONCAWE.

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product dossier no. 99/110

CONTENTS

PREFACE IV

1. INTRODUCTION 1

2. PRODUCT DESCRIPTION 2

3. TYPICAL PROPERTIES 5

4. TOXICITY 6
4.1. ACUTE TOXICITY 6
4.2. IRRITATION AND SENSITIZATION 7
4.3. SUB-ACUTE/SUB-CHRONIC TOXICITY 7
4.3.1. Skin 7
4.3.2. Oral 7
4.4. CHRONIC TOXICITY/CARCINOGENICITY 10
4.4.1. Skin 10
4.4.2. Oral 11
4.4.3. Other routes 11
4.5. GENOTOXICITY 12
4.6. REPRODUCTIVE TOXICITY 12

5. HEALTH ASPECTS 13

6. EXPOSURE LIMITS 14

7. HANDLING ADVICE 15

8. EMERGENCY TREATMENT 16

9. DISPOSAL 17

10. FIRE AND EXPLOSION HAZARDS 18

11. ENVIRONMENTAL HAZARDS 19


11.1. PERSISTENCE AND BIODEGRADATION 19
11.2. TOXICITY - AQUATIC SPECIES 20
11.3. BIOACCUMULATION 20
11.4. CONCLUSION/SUMMARY 20

12. REFERENCES 21

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product dossier no. 99/110

PREFACE

This product dossier is one in a series of 11 on the following major groups of


petroleum products:

- Liquefied petroleum gas

- Gasolines

- Kerosines/jet fuels

- Gas oils (diesel fuels/heating oils)

- Heavy fuel oils

- Lubricating oil basestocks

- Aromatic extracts

- Petroleum waxes and related products

- Bitumens and bitumen derivatives

- Petroleum coke

- Crude oil

These product dossiers are being prepared by CONCAWE to provide, for each
major product group, comprehensive information covering:

- Product description, uses and typical properties

- Toxicology, health aspects and fire, explosion and environmental hazards

- Recommended exposure limits

- Advice on handling, emergency treatment and disposal

- Entries in the European Inventory of Existing Commercial Chemical


Substances (EINECS) which cover these groups.

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product dossier no. 99/110

1. INTRODUCTION

The waxes and related products covered in this dossier are those which are derived
from petroleum and may be grouped as follows:

Paraffin waxes
Microcrystalline waxes
Slack waxes
Petrolatums

A further group of waxes is often identified, which has some of the characteristics of
both paraffinic and microcrystalline waxes. This group is referred to as intermediate
waxes.

The wax-related products are derived primarily from paraffinic crude oils and, as a
consequence, are rich in aliphatic hydrocarbons. Accordingly, the product range
consists almost entirely of straight-chain, branched and cyclo-alkanes having carbon
numbers ranging from C12 to C85.

Petroleum waxes and petrolatums have a large variety of uses and both industrial
users and the general public encounter them regularly since they are contained in
products as disparate as wire cables and cosmetics.

This dossier summarises the available information on slack waxes, paraffin and
microcrystalline waxes and petrolatums.

Since some highly refined petroleum waxes have been used as food additives
and/or food contact materials, a substantial number of toxicological studies have
been carried out to support this usage. The results of these studies have also been
included in this dossier, together with any regulatory limits that have been set for
food or food contact uses.

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product dossier no. 99/110

2. PRODUCT DESCRIPTION

Slack waxes

Crude oils contain varying amounts of different types of wax components. Petroleum
waxes are obtained from paraffinic refinery streams in lubricating oil refinery
processes. In a typical refining process for the manufacture of lubricating oil, wax is
separated by filtering a chilled solution of waxy oil in a selected solvent, usually a
mixture of methyl ethyl ketone and toluene (Sequira, 1994). The waxy material
obtained is commonly identified as slack wax if derived from de-waxing of refined or
unrefined vacuum distillate fractions. Sometimes, the slack waxes may be
hydrotreated directly without being de-oiled. If separated from residual oil fractions,
the oil-bearing slack wax is frequently called petrolatum.

Slack waxes consist mostly of paraffinic hydrocarbons of carbon number C12 to C85.
They contain a residual amount of mineral oil ranging between 5 and 30%. Slack
waxes derived from low viscosity oils contain predominantly normal paraffins. Upon
dewaxing, heavier oil fractions yield slack waxes with increasing proportions of
isoparaffins, cycloparaffins and alkylated aromatics in addition to the normal
paraffins. Commonly, slack waxes are derived from solvent-refined vacuum
distillates, in which case they contain a very low content of alkylated aromatic
hydrocarbons.

Due to their molecular weight distribution, slack waxes have a solid consistency at
ambient temperatures. Melting takes place at around 50°C. Slight separation of oil
on the surface of slack wax at elevated temperatures (“bleeding”) may sometimes
give the product a greasy feel. The colours of slack wax range from almost white to
yellow or dark brown. The water solubility and volatility are very low.

Refined waxes

In a first step, slack waxes are de-oiled by solvent crystallisation or ‘sweating’


processes to manufacture commercial waxes with low oil content. These exhibit
improved hardness (lower penetration) and higher melting point as compared to
slack waxes. The oil, which is separated from these de-oiling processes, is called
foots oil. Except for their higher pour points or melting points due to the presence of
unseparated wax, the properties of foots oils are comparable to the oil intermediate
stream from which wax has been derived. Foots oils are not addressed in this
dossier, but information on these has been included in a dossier on lubricating oil
basestocks (CONCAWE, 1997).

Refining is accomplished by hydrofinishing and clay treating (absorption bleaching)


processes for decolouring and de-odourising the waxes.

Refined petroleum waxes are identified as:

Paraffinic waxes have average molecular weights usually less than 450. They have
a well-defined macrocrystalline structure of large needles or plates, with a melting
point in the range of 43°C to 68°C, typically around 55°C. They consist mainly of
normal alkanes, varying amounts of isoalkanes, cycloalkanes and a very low
concentration of alkylated aromatic hydrocarbons. Paraffin waxes have a translucent
white to yellow colour.

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product dossier no. 99/110

Microcrystalline waxes, have higher molecular weights than paraffinic waxes and
consist of substantial amounts of iso- and cycloalkanes usually with a lesser amount
of normal alkanes and trace amounts of alkylated aromatic hydrocarbons. Although
microcrystalline waxes contain small crystals, much of the material is amorphous.
Microcrystalline waxes usually melt between 60°C and 95°C and have an opaque
appearance with a colour depending on the type and degree of refining applied.

Intermediate waxes or semi-microcrystalline waxes, have properties between the


two basic refined types.

Petrolatums

These are semi-solid petroleum waxes containing substantial amounts of oil,


typically well above 10%. They consist mainly of branched and straight chain alkanes
of carbon numbers C12 to C85. Their soft consistency is due to a gel-like dispersion of
mineral oil in a microcrystalline wax base. They may be regarded as slack waxes
obtained in the initial solvent dewaxing process from residual lubricating base oil
fractions. The colour of industrial grades of petrolatum ranges from dark brown/black
to light yellow. Microcrystalline waxes are obtained from this material by de-oiling.

The term “petrolatum” is also used to describe blends of highly purified waxes and
white mineral oils. In Europe, these blends are referred to commonly as petroleum
jelly.

The properties of oxidised petrolatum (manufactured by air blowing of petrolatum to


obtain polar functional groups beneficial for use in corrosion preventatives) are not
considered in this dossier.

Hydrocarbon waxes and petrolatum for food, food contact, cosmetic,


pharmaceutical and related applications

Hydrocarbon waxes (including paraffins, intermediate waxes and microcrystalline


waxes) and petrolatum (petroleum jelly) that are intended for food, food contact,
cosmetic, pharmaceutical and related applications have to meet stringent purity
requirements as described in the respective national and international legislations
(e.g. food laws, pharmacopoeias). These generally specify melting ranges, colour,
polycyclic aromatic hydrocarbon content and other impurity limits.

In order to achieve this high purity, high-pressure hydrogenation, or a severe


percolation adsorption process (e.g. clay treatment), is used for decolouration,
purification and finishing of the products.

The chemical compositions of these high-purity products, manufactured by either


process, have been investigated (CONCAWE, 1984).

Applications

Waxes and petrolatums are used in a variety of commercial products and


applications such as candles, chipboards, cosmetics, crayons, polishes, hot melts,
cheese coatings, lubricants, paper and board printing inks, telephone cables,
electrical power cables, flexible packaging materials, textiles, lost wax casting and
anti-corrosion compounds.

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Definitions

The Chemical Abstract Services [CAS] numbers and definitions for petroleum waxes
and petrolatums included in EINECS are given in Appendices 1 to 3, where they
have been grouped as follows:

Paraffin and hydrocarbon waxes

Slack waxes

Petrolatums

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product dossier no. 99/110

3. TYPICAL PROPERTIES

Table 1 summarises the typical physical and chemical properties that characterise
the common types of waxes and petrolatums (Bennet, 1975; Kauffman et al. 1993;
EWF, 1990).

Table 1: Physico-chemical properties for typical grades of waxes and petrolatums.

Melting Kinematic Oil content Carbon Penetration


point viscosity at (% m/m) number (25°C)
(°C) 100°C range
(1)
(mm²/s)
(2)
ASTM D127 ASTM D445 ASTM D721 ASTM D2502 ASTM D1321
(3)
or D3235 or D937

Slack waxes /
43-63 3-30 2-30 C12-C85 9-80
Petrolatums

Paraffin waxes 43-68 3-6 <1.5 C18-C60 9-50

Microcrystalline
60-95 10-30 <5 C23-C85 3-60
waxes

Intermediate
64-74 6-10 <2.5 C22-C75 12-30
waxes
(4)
Petrolatums 36-60 3-30 >10 C12-C85 >60
(1) Kinematic viscosity is often expressed in Centistokes (cSt). It should be noted that throughout this dossier the units
for kinematic viscosity are mm²/second (1 mm²/s = 1 cSt)
(2) Melting point by ASTM D87 and congealing point by ASTM D938 are also often used to characterise the melting or
solidification behaviour. Results obtained by these methods may differ significantly.
(3) For slack waxes and petrolatums, penetration is measured by ASTM D937.
(4) The properties given are typical for petroleum jellies.

The data given above are typical properties for the various materials covered in this
product dossier. Additional data have been generated on food grade waxes,
including those that have been included in animal feeding studies. These data have
been summarised elsewhere (CONCAWE, 1984; CONCAWE, 1993).

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product dossier no. 99/110

4. TOXICITY

Toxicological data on waxes have been reviewed previously.

Data provided by the Cosmetics, Toiletries & Fragrances Association (CTFA, 1981)
were reviewed by an expert panel and the report of the evaluation has provided the
majority of the information on acute toxicity, irritation and sensitisation contained in
this product dossier (Anon, 1984).

The EU Scientific Committee for food (SCF) and the WHO Joint Expert Committee
on Food Additives (JECFA) assessed the suitability of waxes for use as food
additives and as food contact materials. As a result of their evaluations, these
committees set Acceptable Daily Intakes (ADIs) for food grade waxes (SCF, 1995;
JECFA 1996).

The ADIs that were established are given in Section 6 of this dossier.

4.1. ACUTE TOXICITY

Oral and skin

There are no published data on the acute toxicity of slack waxes.

The available data on paraffin and microcrystalline waxes are summarised in


Table 2.

Table 2: Summary of acute toxicity data on waxes

Test material LD50 Reference

Oral (rat)

Paraffin wax > 5000 mg/kg Anon, 1984

Paraffin wax >3750 mg/kg Anon. 1984


(75% in corn oil)
Paraffin wax > 5000 mg/kg IBR, 1976a
(10% in arachis oil)

Microcrystalline wax Approx. 10,000 mg/kg Anon, 1984


(20% in corn oil)
Microcrystalline wax > 5000 mg/kg IBR, 1976b
(10% in arachis oil)

Dermal (rabbit)

Paraffin wax >4 ml/kg Anon, 1984


(50% in petrolatum)

The data summarised in Table 2 demonstrate that paraffin wax and microcrystalline
wax are of a low order of acute oral and dermal toxicity. Other studies on cosmetic
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product dossier no. 99/110

products containing 5-16% wax, e.g. eye shadows, eye creams or foot creams also
confirm the low toxicity of the waxes (Anon, 1984).

4.2. IRRITATION AND SENSITIZATION

The expert panel on cosmetics reviewed skin irritation data and reported (Anon,
1984) that an undiluted paraffin wax was non-irritant in a 24 hour occluded patch test
in rabbits.

A further three different paraffin waxes (as 50% solutions in petrolatum) were tested
in a repeated open patch test in rabbits for 3 successive applications. The samples
caused slight erythema in 4/6, 4/6 and 1/6 rabbits respectively for up to 3 days
following treatment. The expert panel also reviewed data on formulated products.
These data confirmed that with the exception of 2 eye shadow formulations,
products containing up to 16% paraffin wax were only slightly irritating to the skin.

A microcrystalline wax was shown to be slightly irritating in a 24 hour occluded patch


test.

Four studies on eye irritation were also reviewed and these demonstrated that
paraffin wax, either undiluted or as a 50% solution in petrolatum was no more than
slightly irritant in a standard Draize eye test in rabbits. Formulated products
containing up to 16% wax produced similar results.

There are no reports of skin sensitization studies with either refined waxes or
petrolatum in laboratory animals.

In summary, the limited data available demonstrate that paraffin waxes and
microcrystalline wax are at most slightly irritating to the skin and eyes. No animal
data are available on either the skin sensitising potential of waxes or on the skin and
eye irritation or skin sensitizing potential of slack waxes.

4.3. SUB-ACUTE/SUB-CHRONIC TOXICITY

4.3.1. Skin

There are no reports of sub-acute or sub-chronic dermal exposure studies on slack


wax, petrolatum or refined wax. However, an eye shadow formulation containing 8%
paraffin wax produced no adverse effects in groups of female albino rats following
skin application (actual dose not reported but stated to be at least 100 times greater
than normal human use concentration) 5 days/week for 13 weeks, (Anon, 1984).

4.3.2. Oral

There are no reported sub-acute or sub-chronic oral studies on either slack wax or
petrolatum.

Three, 90-day feeding studies have been reported for food-grade paraffinic or
microcrystalline waxes (BIBRA, 1992; BIBRA, 1993; API, 1999). Outlines of the
protocols for the three studies are summarised in Table 3, which also includes
limited information on the characterisation of 4 of the waxes and a blend of waxes

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product dossier no. 99/110

that were tested. Further information on the characteristics of the waxes has been
summarised elsewhere (CONCAWE, 1993).

Table 3: Outline of 90-day feeding studies that have been carried out on food grade
waxes

Test Carbon No. Viscosity at Dietary Strain Duration Reversibility


1 2
material distribution 100°C concentrations of rat of feeding period
(mm²/s) (%) (days) (days)

BIBRA, 1992 study

LMPW 19-42 3.3 0, 0.002, 0.02, F344 90 30


HMPW 22-80 15.4 0.2 & 2.0
HSW 20-74 13.7

BIBRA, 1993 study

IMPW 21-49 6.3 0, 0.02, 0.2 & F344 90 90


BLEND 19-80 8 2.0

3
API, 1999 study

LMPW 19-42 3.3 0, 0.2 & 2.0 F344 30, 60 & No reversibility
& SD 90 component in
study

Note
1
LMPW Low Melting Point Wax. (Samples from the same batch of LMPW were used in both studies reported
(BIBRA, 1992; API, 1999)
HMPW High Melting Point Wax
HSW High Sulphur Wax
IMPW Intermediate Melting Point Wax
BLEND 50/50 blend of LMPW/HMPW
2
F344 Fischer 344 rat
SD Sprague Dawley rat
3
Study conducted in female rats only

None of the waxes caused clinical signs of toxicity in any of the feeding studies.
Furthermore, neither the HMPW nor HSW caused any treatment-related
haematological, clinical chemical or histopathological changes.

The only waxes that caused biologically significant changes were those containing
lower molecular weight hydrocarbons i.e. LMPW, IMPW and the 50/50 blend of
LMPW and HMPW. The changes that occurred were consistent in all three studies
and generally were more pronounced in females than males. In the study in which
the effects of LMPW were compared in two strains of rat, effects were more
pronounced in F344 than Sprague Dawley rats (API, 1999).

The histopathological changes that occurred were in the liver and mesenteric lymph
nodes. In addition, a lesion of the mitral valve of the heart was found in the highest
dose groups of the F344 rats for all three wax samples, but the incidence was not
statistically significant in those animals fed IMPW. At the high dose of LMPW, kidney
and spleen weights were also increased but without any associated histopathological
changes.

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The liver effects comprised an increase in organ weight, small increases in serum
liver enzymes, tissue accumulation of mineral hydrocarbons and the development of
granulomatous tissue.

The effects in mesenteric lymph nodes were similar – weight increases, histiocytosis
and accumulation of mineral hydrocarbons.

The effect in the heart was described as focal inflammation within the cusps of the
mitral valve. The lesion was characterised by an increased cellularity of the valve
with destruction of the fibrous core and was associated with an accumulation of
birefringent material. This lesion was not observed in the Sprague Dawley rats even
at the highest dose group after 90-days feeding (API, 1999).

All of the changes observed showed some evidence of reversibility after 90-days
feeding with control diet.

The Lowest Observed Effect Levels (LOELS) for each of these findings in the BIBRA
studies are summarised in Table 4.

Table 4: LOELs for key findings in 90-day feeding studies (CONCAWE, 1993)

LIVER MESENTERIC LYMPH NODE HEART

1,2 2 1,2
Wax Granuloma Organ weight MHC Histiocytosis Organ weight MHC Mitral valve
lesion

LMPW 0.2 (M, F) 0.2 (M, F) 2.0 (M, F) 0.02 (M) 2.0 (M, F) 2.0 (M, F) 2.0 (M)

0.002 (F) 0.2 (F)

3
IMPW 0.2 (M, F) 0.2 (M, F) 2.0 (M, F) 0.02 (M, F) 0.02 (M, F) 2.0 (M, F) --

Blend 0.2 (M, F) 0.2 (F) 2.0 (M, F) 0.02 (M, F) 2.0 (M, F) 2.0 (M, F)

2.0 (M)

HMPW NE NE ND NE NE ND NE

HSW NE NE ND NE NE ND NE
1
NE No effect observed Mineral hydrocarbon measurable in tissues
2
ND Not Detected Evaluated only at 2.0% dietary level
3
Present but not statistically significant (P>0.05)

There is no clear understanding at this time as to why some, though not all, waxes
cause effects under these protocol conditions. Neither is it clear as to the reasons for
the apparent differences in strain sensitivity (API, 1999) to mineral hydrocarbons and
whether these effects are relevant to man (Fleming et al, 1998). Results of
preliminary studies suggest that the difference in tissue accumulation may be a
consequence of absorption and/or metabolic differences between the strains
(Twerdok et al, 1998).

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4.4. CHRONIC TOXICITY/CARCINOGENICITY

The main aim of the chronic toxicity studies conducted on waxes and petrolatums
has been to investigate possible carcinogenicity. Few other effects of long term
exposure have been described. For information on chronic effects of highly refined
mineral oils (a major component of petrolatums and present at low levels in waxes of
all types), see CONCAWE dossier on base oils (CONCAWE, 1997).

4.4.1. Skin

Slack wax

There are three reports of skin carcinogenicity studies with slack wax. Only one
study reports results on waxes produced by solvent extraction, which is the method
of preparation currently practised. The other two reports relate to waxes that were
produced by the older process of “pressing” unrefined or poorly refined materials.

Kane et al, (1984) reported that two slack waxes that had been produced by a
solvent extraction process, rather than by “pressing” were not tumorigenic after
application of 25 mg to the backs of groups of 25 or 50 male C3H mice twice per
week for 80 weeks.

In an older study, 8 slack waxes containing between 12-29% aromatic mineral oil
were tested in a lifetime skin painting study (Smith et al, 1951). In the study,
approximately 15 mg of molten (55°C) slack wax was applied 3 days/week to the
backs of groups of 30 male albino mice.

At 250 days, benign tumours were observed in mice treated with 6 of the 8 waxes
and of these, malignant tumours had developed in only 2 groups. At 450 days,
benign tumours had developed in all groups, but malignant tumours had developed
in only 5 of the 8 groups.

It was concluded that the slack waxes were weakly carcinogenic, and based on
further studies, that the carcinogenic activity was attributable to the aromatic oil
content rather than to the paraffin waxes themselves.

Another study from the same laboratory (Dietz et al, 1952) on 11 slack waxes (it is
unclear whether some were the same samples as in Smith et al, 1951) produced
similar results. The tumour potency of each sample was low to marginal.

Refined wax

A comprehensive investigation was carried out on 36 paraffinic and microcrystalline


waxes, (Shubik et al, 1962) 32 of which were used for food packaging. Measurable
amounts of Polycyclic Aromatic Compounds [PACs] (benzo(a)pyrene,
benzo(e)pyrene, chrysene, fluoranthene, pyrene and triphenylene) were not found in
26 of the waxes and of the remainder, the total concentrations for these PACs
ranged from 0.01 to 0.71 ppm. Five of the waxes (as 15% solutions in benzene)
were applied three times per week to the skins of groups of 60 male and 30 female
Swiss mice and 4 male and 4 female New Zealand White Rabbits over the animal’s
lifetimes. All treated groups showed some mild irritative responses (limited to
desquamation and depilation) that persisted throughout the study but there was no
evidence for a treatment-related increase in tumours or any other effects.

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Petrolatum

No tumours developed following the application of two samples of petrolatum (25 mg


twice weekly for 80 weeks) to 25 or 50 male C3H mice (Kane et al, 1984).

60 µl of a 15% solution of amber petrolatum (petrolatum NF grade) in iso-octane


was applied twice weekly to the skin of 30 male and 30 female Swiss mice for 2
years. Three tumours developed, compared with 2 in a vehicle control group of 50
male and 50 female mice. It was concluded that amber petrolatum was not
carcinogenic (Lijinsky et al, 1966).

4.4.2. Oral

Slack wax

No studies have been reported with slack wax

Refined wax

In a study reported by Shubik et al, (1962), five wax samples were fed to groups of
50 male and 50 female Sprague-Dawley rats at a dietary concentration of 10%
(approximately 5000 mg/kg bw/day) for a period of 2 years. There were no
treatment-related changes in survival or growth, neither were there any abnormal
effects at necropsy or upon histological examination. Tumour incidence was
unaffected by treatment.

Petrolatum

Pharmaceutical and food-grade petrolatums were fed to groups of 50 male and 50


female FDRL rats at dietary concentrations of 5% for 2 years (Oser et al, 1965). The
petrolatums were described as grade A – snow white, grade B – white and grade C
– yellow and each was a blend of up to 6 samples of different origin.

Body weights, blood chemistry and haematological measurements were conducted


during treatment. At necropsy the weights of liver, spleen, kidney, heart, adrenals,
thyroid and pituitary were recorded and a range of tissues were examined
histologically.

No treatment-related changes were observed.

4.4.3. Other routes

Slack wax

No data have been reported.

Refined wax

Subcutaneous

Subcutaneous implantation of a single wax disk (2 cm diameter, 2 mm thick and


weighing 0.5 g) was made in groups of approximately 45 male and 50 female Swiss
mice. This was done for 5 different paraffin waxes. Additionally, 0.5 g of one of the
waxes was implanted as a powder in a further group of 48 male and 46 female

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Swiss mice (Shubik et al, 1962). The animals and their corresponding controls were
observed for their lifetime.

Tumours developed at the implantation site of the wax disks but not at the site of the
powdered wax. These findings are consistent with other reports on the tumorigenic
response of materials implanted subcutaneously. It is generally recognised that such
responses are related to physical form rather than to inherent tumorigenicity
(Oppenheimer et al, 1961).

Petrolatum

Subcutaneous

Three kinds of pharmaceutical and food grade petrolatums were administered


subcutaneously to groups of 100, 28 day old Swiss-Webster mice (Oser et al, 1965).
The petrolatums have been described in Section 4.4.2 above.

The animals were given a single 100 mg subcutaneous dose of petrolatum and were
then observed for 18 months at which time a range of tissues were examined for
gross and microscopic changes.

The treatment did not cause tumour formation. However, some effects were
observed that may have been treatment-related, e.g. chronic inflammation was
present in the lymphatic system at 9 and 12 months but not at 18 months and there
were local changes at the site of injection (encapsulation of the petrolatum).

A petrolatum was injected subcutaneously (1 ml) into 26 rats that were then
observed until their death (Schmähl & Reiter, 1953). The only noteworthy finding was
the occurrence of an osteosarcoma at the site of injection in one treated animal.

4.5. GENOTOXICITY

No information on genotoxicity is available.

4.6. REPRODUCTIVE TOXICITY

No information on reproductive toxicity is available.

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5. HEALTH ASPECTS

Slack wax

There are no published reports of acute effects in humans with slack waxes but they
are expected to be essentially non-toxic. They may be slightly irritating to the skin.

There have been several reports of human occupational cancer amongst wax
pressmen, during the preparation of paraffin wax (Hendricks et al, 1959; Lione and
Denholm, 1959). In the process of wax pressing the unrefined or poorly refined oil
was chilled and the solidified crude wax (slack wax) removed from the viscous oil on
filter presses. This crude wax may have contained as much as 20-40%
unrefined/poorly refined oil, which was reduced to less than 0.5% in subsequent
processing.

Paraffin wax

A review of the clinical studies with two undiluted paraffin waxes and formulated
products containing various concentrations of paraffinic (5-16%) and microcrystalline
(4.35-15%) waxes was published (Anon, 1984). These studies include a range of
acute and repeat application tests in groups of humans for skin irritation and skin
sensitization. All products gave at most slight erythema and none caused skin
sensitization.

Their widespread use in cosmetic and in cosmetic surgery over many years
demonstrates the low toxicity of refined waxes and many guidelines exist for their
safe use (Hjorth, 1987). Notwithstanding this, there are occasional reports of
adverse effects with these products. Subcutaneous deposits, often referred to as
paraffinoma, have been described frequently following injection of these materials
under the skin but these are not normally associated with other progressive
changes.

There has been one report where an outbreak of skin rashes was attributed to
occupational exposure to wax fume (Halton & Piersol, 1994).

Petrolatum

Despite the widespread use of petrolatum for many years as a vehicle in human skin
patch testing, isolated cases of allergy to petrolatum have been reported (Frankel,
1965; Dooms-Goosens & Degreef, 1983; Ayadi & Martin, 1987; Fisher, 1981; Conti
et al, 1995). Nevertheless, petrolatum is still considered to be a good vehicle for
human patch testing. Fisher concluded that although allergic reactions to petrolatum
are rare, white and not yellow petrolatum should be used as a vehicle in human skin
patch testing.

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6. EXPOSURE LIMITS

An occupational exposure limit for paraffin wax fume has been established in the UK
as follows (UK HSE, 1999):

2 mg/m³ 8 hour TWA


6 mg/m³ 15 minute STEL.

Additionally ACGIH have published (ACGIH, 1998) a TLV of 2 mg/m³ as an 8 hour


TWA.

In view of their use as food additives and food contact materials, Acceptable Daily
Intakes (ADIs) have been set for waxes by the EU Scientific Committee for Food
(SCF, 1995) and the World Health Organisation Joint Expert Committee on Food
Additives (JECFA, 1996).

The limits are as follows:

SCF

ADI of 0-20 mg/kg bw for waxes conforming to the following specifications:


2 -1
Viscosity : not less than 11mm s (centistokes) at 100°C

Carbon number : not less than 25 at the 5% boiling point

Average molecular weight : not less than 500

JECFA

ADI of 0-20 mg/kg for microcrystalline waxes.

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product dossier no. 99/110

7. HANDLING ADVICE

Waxes and related products should be handled according to good industrial hygiene
practices. High standards of personal hygiene and plant cleanliness should be
maintained at all times

The following is recommended:

• Individuals handling or using waxes or petrolatums should be advised of the


hazards and the proper handling instructions especially where the waxes may be
handled at high temperatures in the molten state.

• Contact with hot wax may cause burns and skin contact with molten wax should
therefore be avoided.

• Hands should be washed thoroughly after contact with wax.

• Prolonged or repeated skin contact with either fresh or used product should be
avoided.

• Avoid contact with the eyes. If splashing of hot, molten material is likely to occur
a full face visor or chemical goggles as appropriate should be worn.

• Clothes should be laundered regularly; soiled clothes should be removed after


use and laundered.

• Disposable cloths should be used and they should be discarded after use. Soiled
cloths should never be put into pockets.

• Rags and paper or other materials that have been used to absorb spillages
represent a fire hazard and should not be allowed to accumulate. They should
be disposed of safely immediately after use.

• Stored product should not be allowed to overheat.

• Protect drains from spills and prevent entry of hot molten material, since this
may result in blockage on cooling. If this should happen, notify the appropriate
authority immediately.

• Clean up spillages promptly as these may make surfaces slippery.

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product dossier no. 99/110

8. EMERGENCY TREATMENT

During normal handling and use, waxes and petrolatums are unlikely to cause any
harmful effects. However, in the event that over-exposure has occurred the following
measures are recommended.

Eyes

Cold wax: Wash eye thoroughly with copious amounts of water, ensuring that the
eyelids are held open.

Obtain medical advice if any pain or redness develops or persists.

Hot wax: Flood with water to dissipate heat. In the event of any material
remaining, do not try to remove it other than by continued irrigation with
water.

OBTAIN MEDICAL ATTENTION IMMEDIATELY.

Skin

Cold wax: Wash contaminated skin with soap and water.

Remove contaminated clothing and wash underlying skin as soon as


reasonably practical.

Hot wax: Flood the skin with cold water to dissipate heat, cover with clean cotton
or gauze, obtain medical advice.

Ingestion

If contamination of the mouth occurs, wash out thoroughly with water.

Except as a deliberate act, the ingestion of large amounts of wax or


petrolatum is unlikely. If it should occur, do not induce vomiting, obtain
medical advice.

Inhalation

If inhalation of fumes from overheated wax or petrolatum causes irritation


of the nose or throat, or coughing, remove the patient to the fresh air.

Obtain medical advice if symptoms persist.

16
product dossier no. 99/110

9. DISPOSAL

The need to dispose of large quantities of wax or petrolatum should seldom arise.
However, in the event that it should be necessary, it is preferable to arrange for the
product to be recycled. Disposal should be accomplished through an authorised
person/licensed waste disposal contractor in accordance with local regulations.

Incineration of product may be carried out under controlled conditions, provided that
local regulations for emissions are met.

In the event of a spill of molten wax, care should be taken to prevent the spilled
material from entering drains or ditches.

The bulk of spilled solid material should be scraped up and any liquid should be
removed using sand or other suitable absorbent material. If necessary, clean the
contaminated area using hot water and detergent, absorb the washings – do not
wash them into drains.

General advice on how to handle waste or spilled material can be obtained from
previously published CONCAWE reports (CONCAWE, 1980; 1981; 1983; 1988).

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product dossier no. 99/110

10. FIRE AND EXPLOSION HAZARDS

Slack waxes, paraffin waxes and petrolatums have high flash points and are not,
therefore, classified as flammable. Fire and explosion hazards are minimal.

Slack waxes, paraffin waxes and petrolatums will burn if ignited.

Foam, dry powder or water fog should be used to extinguish fires.

DO NOT USE WATER JETS

Fires in confined spaces should be dealt with by trained personnel wearing approved
breathing apparatus.

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product dossier no. 99/110

11. ENVIRONMENTAL HAZARDS

11.1. PERSISTENCE AND BIODEGRADATION

Waxes and petrolatums are complex mixtures of hydrocarbons (predominantly


higher molecular weight alkanes), with carbon numbers in the range C12 to C85
(waxes) and C20 to C85 (petrolatums). On release to the environment, these
materials will not be mobile, being essentially non-volatile and very poorly water-
soluble. Any hydrocarbons that do partition to the air are likely to be rapidly
photodegraded, by reaction with hydroxyl radicals. Waxes and related products are
likely to float on the surface of water.

The assimilation of paraffin waxes has been described for a diverse range of micro-
organisms following laboratory studies; a wide range of bacteria, yeasts and fungi
have been shown to grow on paraffin wax as a sole carbon source under aerobic
conditions (Rahn, 1906; Sohngen, 1913; Fuhs, 1961; Miyamoto, 1968). Initial
decomposition of wax has been suggested (Miyamoto, 1968) to be similar to the
degradation of short chain alkanes. Assimilation of a highly refined paraffin wax
containing 91% of normal paraffins from C25 to C37 (mainly C28 to C32) has been
found with many species of bacteria and yeast (Yamada and Yogo, 1970). Yeast
cultures grown on paraffin wax (Miller and Johnson, 1966) has resulted in typical cell
yields of 70% although incomplete utilisation of paraffin wax occurred.

The oxidation of normal alkanes from C7 - C44 has been determined using a soil
suspension as innoculum (Haines and Alexander, 1974). From an initial
concentration of 3 mg/l at 25°C, the rate of biological oxygen demand (BOD)
decreases with molecular weight at 2, 5 and 10 days, but at 20 days the ultimate
BOD overall varied within 70 to 79% of the theoretical oxygen demand (TOD). The
ultimate BOD at day 35 of selected alkanes of C6 - C31 was found to vary within 66 to
84% TOD (ZoBell, 1963).

The inherent biodegradation of paraffin (C19 – C47 n-alkanes), intermediate (C22 – C54
n-alkanes) and microcrystalline (C20 – C73 alkanes) waxes was determined
(Hanstveit, 1991a) using modifications to the OECD Guideline 301B method, which
included a pre-adapted soil innoculum. The biodegradation of paraffin waxes was 78
to 84% after 28 days and 85 to 98% after 84 days, while the intermediate wax gave
biodegradation levels of 66% after 28 days and 77% after 84 days. By comparison,
the microcrystalline wax was only slowly degraded (25% after 84 days). The
residues remaining at the end of the 84 day tests were 11%, 8% and 65% for the
three waxes respectively, with extensive degradation below C50 for the paraffin and
intermediate waxes, although only n- alkanes below C43 and iso alkanes degraded in
the microcrystalline wax.

Only limited data are available on the degradability of waxes and petrolatums in
standard OECD tests, though they would not be expected to meet the criteria for
‘ready biodegradability’. The biodegradability of three samples of hydrotreated slack
wax, of varying viscosity has been investigated using a method based on the
modified Sturm test (OECD method 301B). The test samples were emulsified in test
medium using anionic surfactant. After 28 days, 48%, 41% and 26% biodegradation
was reported, with the biodegradation decreasing with increasing viscosity. The
results of these studies provide evidence for the inherent biodegradability of these
materials. For comparison, the same samples evaluated using the CEC L-33-T82

19
product dossier no. 99/110

method gave 73%, 60% and 50% biodegradation respectively (Battersby et al, 1992;
Battersby, 1993).

An environmental study of the decomposition of paraffin, intermediate and


microcrystalline waxed paper samples has been described in a woodland leaf litter
layer (Hanstveit, 1991b). During a six-month winter period a near complete
degradation of paraffin and intermediate waxed paper samples occurred in 5 mm
mesh bags with a half-life value of approximately two months. Lower decomposition
rates occurred in the summer period and also for a microcrystalline waxed paper
sample. Both soil micro- and macro-organisms contributed to the decomposition
under field conditions.

11.2. TOXICITY - AQUATIC SPECIES

A comprehensive literature search confirms that there is no published information on


the aquatic toxicity of petroleum waxes. However, work by Adema and van den Bos
Bakker on the ecotoxicity of alkanes to Daphnia magna, Chaetogamarus marinus
and Mysidopsis bahia has shown that the alkanes of carbon number greater than
C10 are not acutely toxic to these species at their limit of solubility in water (Adema
and van den Bos Bakker, 1986). Since paraffin waxes are largely composed of
alkanes of carbon number greater than C20, they will not be acutely toxic to aquatic
invertebrates. Similarly, by inference from the results of chronic ecotoxicity studies
that have been conducted on lubricant base oils (CONCAWE, 1997), waxes and
petrolatums would not be expected to cause chronic effects in aquatic organisms.

11.3. BIOACCUMULATION

There are no known experimental data relating to the bioaccumulation of waxes and
petrolatums in environmental organisms. These materials have estimated log KOW
values greater than 6, suggesting a potential to bioaccumulate. In practice however,
there is no evidence of accumulation, which is likely to be limited by both physico-
chemical considerations and metabolic processes (hydrocarbons are poorly soluble
in water so that concentrations will always be low, higher molecular weight
hydrocarbons are too large to be readily absorbed through biological membranes
and, if they are absorbed, there is evidence of metabolism in many species).

11.4. CONCLUSION/SUMMARY

In conclusion, paraffin waxes are inherently biodegradable, although the rate is likely
to be slow and they may persist in the environment for some time. The rate of
biodegradation will be influenced by temperature, availability of hydrogen acceptors
and total surface area exposed to microbial enzymatic attack. Based on the
chemical composition and high molecular weight of petroleum waxes, these would
not be expected to be harmful to aquatic species. There is no evidence to suggest
that petroleum waxes are hazardous to species in the environment.

20
product dossier no. 99/110

12. REFERENCES

ACGIH (1998) Threshold limit values (TLVs) for chemical substances and physical
agents and biological exposure indices (BEIs) - 1998. Cincinnati OH: American
Conference of Governmental Industrial Hygienists

Adema, D.M.M. and van den Bos Bakker, G.H. (1986) Aquatic toxicity of compounds
that may be carried by ships (Marpol 1973, Annex II). Progress report for 1986 from
TNO to the Dutch Ministry of Housing, Physical Planning and the Environment.
Report No. 86/326a. Delft: TNO

Anonymous (1984) Final report on the safety assessment of fossil and synthetic
waxes. J Am College Toxicol 3, 3, 43-99

API (1999) A subchronic 90-day dietary toxicity study of a low melting point paraffin
wax in two rat strains. Study No. 95-2394 conducted by Huntingdon Life Sciences.
Unpublished report. Washington DC: American Petroleum Institute

Ayadi, M. and Martin, P. (1987) Contact allergy to petrolatum. Contact Dermatitis 16,
1, 51

Battersby, N.S. et al (1992) A correlation between the biodegradability of oil products


in the CEC L-33-T-82 and modified Sturm tests. Chemosphere 24, 12, 1989-2000
rd
Battersby, N.S. (1993) Personal communication to CONCAWE, 3 September 1993

Bennet, H. (1975) Industrial waxes. Volume 1: Natural & synthetic waxes. New York:
Chemical Publishing Company Inc.

BIBRA (1992) A 90-day feeding study in the rat with six different mineral oils (N15
(H), N70 (H), N70 (A), P15 (H), N10 (A) and P100 (H), three different waxes (a low
melting point wax, a high melting point wax and a high sulphur wax) and coconut oil.
BIBRA Project no. 3.1010

BIBRA (1993) A 90-day feeding study in the rat with two mineral waxes identified as
paraffin wax 64 (OFH-064) and micro/paraffin wax mixture. BIBRA Project no.
3.1205

CONCAWE (1980) Disposal techniques for spilt oil. Report No. 9/80. Brussels:
CONCAWE

CONCAWE (1981) A field guide to coastal oil spill control and clean-up techniques.
Report No. 9/81. Brussels: CONCAWE

CONCAWE (1983) A field guide to inland oil spill and clean-up techniques. Report
No. 10/83. Brussels: CONCAWE

CONCAWE (1984) Assessment and comparison of the composition of food-grade


white oils and waxes manufactured form petroleum by catalytic hydrogenation
versus conventional treatment. Report No. 84/60. Brussels: CONCAWE

CONCAWE (1988) A field guide to the application of dispersants to oil spills. Report
No. 2/88. Brussels: CONCAWE

21
product dossier no. 99/110

CONCAWE (1993) White oils and waxes - summary of 90-day studies. Report No.
93/56. Brussels: CONCAWE

CONCAWE (1997) Lubricating oil basestocks. Product Dossier No. 97/108.


Brussels: CONCAWE

Conti, A. et al (1995) Sensitization to white petrolatum used as a vehicle for patch


testing.Contact Dermatitis 33, 201-202

CTFA (1981) Waxes: summary of unpublished safety data. Prepared for Cosmetic
Ingredient Review by the Cosmetic, Toiletry and Fragrance Assoc. Inc. Washington
DC

Dietz, W.A. et al (1952) Properties of high boiling petroleum products:


carcinogenicity studies. Ind Eng Chem 44, 8, 1818-1827

Dooms-Goossens, A. and Degreef, H. (1983) Contact allergy to petrolatums.


1. Sensitizing capacity of different brands of yellow and white petrolatums. Contact
Dermatitis 9, 175-185

EWF (1990) Specifications for petroleum derived hydrocarbon waxes - food grade.
Brussels: European Wax Federation

Fisher, A.A. (1981) Cutaneous reactions to petrolatum. Cutis 28, 23

Fleming, K.A. et al (1998) Granulomas in the livers of humans and Fischer rats
associated with the ingestion of mineral hydrocarbons: a comparison. Regul Toxicol
and Pharmacol 27, 75-81

Frankel, E.B. (1985) Acne secondary to white petrolatum use. Arch Dermatol 121,
589-590

Fuhs, G.W. (1961) Der mikrobielle Abbau von Kohlenwasserstoffen. Archiv für
Mikrobiologie 39, 374-422

Haines, J.R. and Alexander, M. (1974) Microbial degradation of high-molecular-


weight alkanes. Applied Microbiol 28, 6, 1084-1085

Halton, D.M. and Piersol, P. (1994) Investigation into an outbreak of rashes in a wax
coating treatment process. Appl Occup Environ Hyg 9, 12, 941-944

Hanstveit, A.O. (1991a) Inherent biodegradability of waxes. Report No. R 90/198b.


Delft: TNO

Hanstveit, A.O. (1991b) A study of the fate of waxed paper materials in a woodland
litter layer. Report No. R 90/243a. Delft: TNO

Hendricks, N.V. et al (1959) Cancer of the scrotum in wax pressmen.


I. Epidemiology. AMA Arch Ind Health 19, 524-529

Hjorth, N. (1987) Diagnostic patch testing. In: Marzulli, F.N. and Maibach, H.I. (Eds).
rd
Dermato-toxicology (3 ed.). Chapter 13, p. 307-317. Washington DC: Hemisphere
Publishing Corp.

22
product dossier no. 99/110

IBR (1976a) Akute Toxizitätsprüfung von 'R 9107' nach oraler Applikation an der
Ratte. Hannover: International Bio-Research

IBR (1976b) Akute Toxizitätsprüfung von 'R 9269' nach oraler Applikation an der
Ratte. Hannover: International Bio-Research

JECFA (1996) Toxicological evaluation of certain food additives and contaminants.


th
Prepared by the 44 meeting of the Joint FAO/WHO expert committee on food
additives (JECFA). WHO Food Additives Series 35. Geneva: World Health
Organization

Kane, M.L. et al (1984) Toxicological characteristics of refinery streams used to


manufacture lubricating oils. Am J Ind Med 5, 183-200

Kaufman, J.J. and Weisberger, G.A. (1993) Petroleum waxes, including petrolatums.
th
ASTM Manual on significance of tests for petroleum products (6 ed). Chapter 10.

Lijinsky, W. et al (1966) Skin tumorigenesis by an extract of amber petrolatum.


Toxicol Applied Pharmacol 8, 113-117

Lione, J.G. and Denholm, J.S. (1959) Cancer of the scrotum in wax pressmen.
II. Clinical observations. AMA Arch Ind Health 19, 530-539

Miller, T.L. and Johnson, M.J. (1966) Utilization of gas oil by a yeast culture.
Biotechnology and Bioengineering VIII, 567-580

Miyamoto, Y. (1968) On cerophility of microbes. Physiology and Ecology 15, 55-66

Oppenheimer, E.T. et al (1961) Observations on the effects of powdered polymer in


the carcinogenic process. Cancer Research 21, 132-134

Oser, B.L. et al (1965) Toxicologic studies of petrolatum in mice and rats. Toxicol
Applied Pharmacol 7, 382-401

Rahn, O. (1906) Ein Paraffin zersetzender Schimmelpilz. Centralblatt f Bakt Abt II


16, 382-384

SCF (1995) Opinion on mineral and synthetic hydrocarbons (expressed on 22


September 1995). CS/ADD/MsAd/132-FINAL. Brussels: European Commission

Schmähl, D. and Reiter, A. (1953) Versuche zur Krebserzeugung mit flüssigem


Paraffin, gelber Vaseline und Wollfett. Arzneimittel-Forsch 3, 403-406

Sequira, A. (1994) Lubricant base oil and wax processing. New York: Marcel Dekker
Inc.

Shubik, P. et al (1962) Studies on the toxicity of petroleum waxes. Toxicol Applied


Pharmacol 4, Suppl, 1-61

Smith, W.E. et al (1951) Experimental analysis of the carcinogenic activity of certain


petroleum products. Arch Ind Hyg Occ Med 4, 299-314

Söhngen, N.L. (1913) Oxidation of petroleum, paraffin, paraffin oil and benzine by
microbes. Proc Royal Acad Amsterdam XV, 1145-1151

23
product dossier no. 99/110

Twerdok, L.E. et al (1998) Comparison of immunopathological changes following


subchronic feeding of low melt point paraffin wax in two strains of rats. API Report in
press. Washington DC: American Petroleum Institute

UK HSE (1999) Occupational exposure limits 1999. HSE Guidance Note EH40/99.
London: Health and Safety Executive

Yamada, K. and Yogo, M. (1970) Studies on the utilization of hydrocarbons by


microorganisms. Part XV. Yeast and bacterial cell production from paraffin wax. Agr
Biol Chem 34, 2, 296-301

ZoBell, C.E. (1963) The occurrence, effects, and fate of oil polluting the sea. Int J Air
Wat Poll 7, 173-198

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product dossier no. 99/110

APPENDIX 1

PARAFFIN AND HYDROCARBON WAXES

EINECS No. CAS No.

232-315-6 8002-74-2

Paraffin waxes and Hydrocarbon waxes

A complex combination of hydrocarbons obtained from petroleum fractions by


solvent crystallization (solvent deoiling) or by the sweating process. It consists
predominantly of straight chain hydrocarbons having carbon numbers predominantly
greater than C20.

264-038-1 63231-60-7

Paraffin waxes and hydrocarbon waxes, microcryst.

A complex combination of long, branched chain hydrocarbons obtained from


residual oils by solvent crystallization. It consists predominantly of saturated straight
and branched chain hydrocarbons predominantly greater than C35.

265-126-2 64742-26-3

Hydrocarbon waxes (petroleum), acid-treated

A complex combination of hydrocarbons produced by treating a petroleum wax


fraction with sulfuric acid. It consists predominantly of saturated straight and
branched chain hydrocarbons having carbon numbers predominantly in the range of
C20 through C50.

265-134-6 64742-33-2

Hydrocarbon waxes (petroleum), chemically neutralized

A complex combination of hydrocarbons produced by a treating process to remove


acidic materials. It consists predominantly of saturated straight chain hydrocarbons
having carbon numbers predominantly in the range of C20 through C50.

265-144-0 64742-42-3

Hydrocarbon waxes (petroleum), clay-treated microcryst.

A complex combination of hydrocarbons obtained by treatment of a petroleum


microcrystalline wax fraction with natural or modified clay in either a contacting or
percolation process to remove the trace amounts of polar compounds and impurities
present. It consists predominantly of long branched chain hydrocarbons having
carbon numbers predominantly in the range of C25 through C50.

25
product dossier no. 99/110

265-145-6 64742-43-4

Paraffin waxes (petroleum), clay-treated

A complex combination of hydrocarbons obtained by treatment of a petroleum wax


fraction with natural or modified clay in either a contacting or percolation process to
remove the trace amounts of polar compounds and impurities present. It consists
predominantly of straight chain saturated hydrocarbons having carbon numbers in
the range of C20 through C50.

265-154-5 64742-51-4

Paraffin waxes (petroleum), hydrotreated

A complex combination of hydrocarbons obtained by treating a petroleum wax with


hydrogen in the presence of a catalyst. It consists predominantly of straight chain
paraffinic hydrocarbons having carbon numbers predominantly in the range of about
C20 through C50.

265-163-4 64742-60-5

Hydrocarbon waxes (petroleum), hydrotreated microcryst.

A complex combination of hydrocarbons obtained by treating a petroleum


microcrystalline wax with hydrogen in the presence of a catalyst. It consists
predominantly of long, branched chain hydrocarbons having carbon numbers
predominantly in the range of C25 through C50.

285-095-9 85029-72-7

Hydrocarbon waxes (petroleum), deodorized

A complex combination of hydrocarbons obtained by the treatment of a paraffin


fraction with steam under vacuum. The steam volatile and odiferous components
were largely removed. It consists predominantly of straight and branched chain
hydrocarbons having carbon numbers predominantly in the range of C20 through C50.

292-640-4 90669-47-9

Paraffin waxes (petroleum), acid-treated

A complex combination of hydrocarbons obtained as a raffinate from a petroleum


wax fraction by a sulfuric acid treating process. It consists predominantly of straight
chain saturated hydrocarbons having carbon numbers predominantly greater than
C20.

295-456-2 92045-74-4

Paraffin waxes (petroleum), low-melting

A complex combination of hydrocarbons obtained from petroleum fractions by


solvent crystallization (solvent deoiling), by sweating or an adducting process. It
consists predominantly of straight chain saturated hydrocarbons having carbon
numbers predominantly greater than C12.

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product dossier no. 99/110

295-457-8 92045-75-5

Paraffin waxes (petroleum), low-melting, hydrotreated

A complex combination of hydrocarbons obtained from petroleum fractions by


solvent crystallization (solvent deoiling), by sweating or an adducting process,
treated with hydrogen in the presence of a catalyst. It consists predominantly of
straight chain saturated hydrocarbons having carbon numbers predominantly greater
than C12.

295-458-3 92045-76-6

Paraffin waxes and Hydrocarbon waxes, microcryst, hydrotreated

A complex combination of hydrocarbons obtained from residual oils by solvent


crystallisation and treated with hydrogen in the presence of a catalyst. It consists
predominantly of saturated straight and branched chain hydrocarbons having carbon
numbers predominantly greater than C25.

307-045-8 97489-05-9

Paraffin waxes and Hydrocarbon waxes, C19-38

308-140-7 97862-89-0

Paraffin waxes (petroleum), carbon-treated

A complex combination of hydrocarbons obtained by the treatment of petroleum


fractions with activated carbon for removal of the trace constituents and impurities. It
consists predominantly of saturated straight chain hydrocarbons having carbon
numbers predominantly greater than C20.

308-141-2 97862-90-3

Paraffin waxes (petroleum), low-melting, carbon-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


petroleum fractions with activated carbon for removal of trace constituents and
impurities. It consists predominantly of saturated straight chain hydrorcarbons having
carbon numbers predominantly greater than C12.

308-142-8 97862-91-4

Paraffin waxes (petroleum), low-melting, clay-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


petroleum fractions with bentonite for removal of trace constituents and impurities. It
consists predominantly of saturated straight chain hydrocarbons having carbon
numbers predominantly greater than C12.

27
product dossier no. 99/110

308-143-3 97862-92-5

Paraffin waxes (petroleum), low-melting, silicic acid-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


petroleum fractions with silicic acid for removal of trace constituents and impurities.
It consists predominantly of saturated straight chain hydrocarbons having carbon
numbers predominantly greater than C12.

308-144-9 97862-93-6

Paraffin waxes (petroleum), silicic acid-treated

A complex combination of hydrocarbons obtained by the treatment of petroleum


paraffin waxes with silicic acid for the removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers predominantly greater than C20.

308-145-4 97862-94-7

Paraffin waxes and Hydrocarbon waxes, microcryst, carbon-treated

A complex combination of hydrocarbons obtained from residual oils by solvent


crystallization treated with activated carbon for removal of trace polar constituents
and impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers greater than C25.

308-147-5 97862-95-8

Paraffin waxes and Hydrocarbon waxes, microcryst, clay-treated

A complex combination of hydrocarbons obtained from residual oils by solvent


crystallization treated with bentonite for removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched
hydrocarbons having carbon numbers predominantly greater than C25.

308-148-0 97862-96-9

Paraffin waxes and Hydrocarbon waxes, microcryst, silicic acid-treated

A complex combination of hydrocarbons obtained from residual oils by solvent


crystallization treated with silicic acid for removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers predominantly greater than C25.

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product dossier no. 99/110

APPENDIX 2

SLACK WAXES

EINECS No. CAS No.

265-165-5 64742-61-6

Slack wax (petroleum)

A complex combination of hydrocarbons obtained from a petroleum fraction by


solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy
crude. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers predominantly greater than C20.

292-659-8 90669-77-5

Slack wax (petroleum), acid-treated

A complex combination of hydrocarbons obtained as a raffinate by treatment of a


petroleum slack wax fraction with sulfuric acid treating process. It consists
predominantly of saturated straight and branched chain hydrocarbons having carbon
numbers predominantly greater than C20.

292-660-3 90669-78-6

Slack wax (petroleum), clay-treated

A complex combination of hydrocarbons obtained by treatment of a petroleum slack


wax fraction with natural or modified clay in either a contacting or percolation
process. It consists predominantly of saturated straight and branched hydrocarbons
having carbon numbers predominantly greater than C20.

295-523-6 92062-09-4

Slack wax (petroleum), hydrotreated

A complex combination of hydrocarbons obtained by treating slack wax with


hydrogen in the presence of a catalyst. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predominantly
greater than C20.

295-524-1 92062-10-7

Slack wax (petroleum), low-melting

A complex combination of hydrocarbons obtained from a petroleum fraction by


solvent deparaffination. It consists predominantly of saturated straight and branched
chain hydrocarbons having carbon numbers predominantly greater than C12.

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product dossier no. 99/110

295-525-7 92062-11-8

Slack wax (petroleum), low-melting, hydrotreated

A complex combination of hydrocarbons obtained by treatment of low-melting


petroleum slack wax with hydrogen in the presence of a catalyst. It consists
predominantly of saturated straight and branched chain hydrocarbons having carbon
numbers predominantly greater than C12.

308-155-9 97863-04-2

Slack wax (petroleum), low-melting, carbon-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


slack wax with activated carbon for the removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers predominantly greater than C12.

308-156-4 97863-05-3

Slack wax (petroleum), low-melting, clay-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


petroleum slack wax with bentonite for removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers predominantly greater than C12.

308-158-5 97863-06-4

Slack wax (petroleum), low-melting, silicic acid-treated

A complex combination of hydrocarbons obtained by the treatment of low-melting


petroleum slack wax with silicic acid for the removal of trace polar constituents and
impurities. It consists predominantly of saturated straight and branched chain
hydrocarbons having carbon numbers pre-dominantly greater than C12.

309-723-9 100684-49-9

Slack wax (petroleum), carbon-treated

A complex combination of hydrocarbons obtained by treatment of petroleum slack


wax with activated charcoal for the removal of trace polar constituents and
impurities.

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product dossier no. 99/110

APPENDIX 3

PETROLATUMS

EINECS No. CAS No.

232-373-2 8009-03-8

Petrolatum

A complex combination of hydrocarbons obtained as a semi-solid from dewaxing


paraffinic residual oil. It consists predominantly of saturated crystalline and liquid
hydrocarbons having carbon numbers predominantly greater than C25.

265-206-7 64743-01-7

Petrolatum (petroleum), oxidized

A complex combination of organic compounds, predominantly high molecular weight


carboxylic acids, obtained by the air oxidation of petrolatum.

285-098-5 85029-74-9

Petrolatum (petroleum), alumina-treated

A complex combination of hydrocarbons obtained when petrolatum is treated with


Al203 to remove polar components and impurities. It consists predominantly of
saturated, crystalline, and liquid hydrocarbons having carbon numbers
predominantly greater than C25.

295-459-9 92045-77-7

Petrolatum (petroleum), hydrotreated

A complex combination of hydrocarbons obtained as a semi-solid from dewaxed


paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists
predominantly of saturated microcrystalline and liquid hydrocarbons having carbon
numbers predominantly greater than C20.

308-149-6 97862-97-0

Petrolatum (petroleum), carbon-treated

A complex combination of hydrocarbons obtained by the treatment of petroleum


petrolatum with activated carbon for the removal of trace polar constituents and
impurities. It consists predominantly of saturated hydrocarbons having carbon
numbers predominantly greater than C20.

31
product dossier no. 99/110

308-150-1 97862-98-1

Petrolatum (petroleum), silicic acid-treated

A complex combination of hydrocarbons obtained by the treatment of petroleum


petrolatum with silicic acid for the removal of trace polar constituents and impurities.
It consists predominantly of saturated hydrocarbons having carbon numbers
predominantly greater than C20.

309-706-6 100684-33-1

Petrolatum (petroleum), clay-treated

A complex combination of hydrocarbons obtained by treatment of petrolatum with


bleaching earth for the removal of traces of polar constituents and impurities. It
consists predominantly of hydrocarbons having carbon numbers predominantly in
the range of greater than C25.

32

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