HCG+SS Calset: Safety Data Sheet

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

HCG+ß CalSet
Version Revision Date: Date of last issue: 05.08.2021
2.4 14.08.2021 Date of first issue: 15.10.2013
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier

Trade name : HCG+ß CalSet
Product code : 03302652190
1.2 Relevant identified uses of the substance or mixture and uses advised against
Recommended restrictions : For professional users only.
on use
1.3 Details of the supplier of the safety data sheet

Company : Roche Diagnostics Deutschland GmbH
-
Sandhoferstrasse 116
68305 Mannheim
Deutschland
Telephone : +496217590
Telefax : +496217592890
Responsible Department : +49(0)621-759-4223 +49(0)8856-60-7547
E-mail address : [email protected]
1.4 Emergency telephone number
In case of emergencies: : Central Works Security +49(0)621-759-2203
Roche Diagnostics GmbH
Centre for detoxification: : Mainz +49(0)6131-19240

Munich +49(0)89-19240
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture

The product is a kit consisting of individual ingredients. The classification of the ingredients can be
obtained from section 3. Section Label elements contains the resulting labelling for the kit.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)

Hazard pictograms :
Signal word : Warning
Hazard statements : H317 May cause an allergic skin reaction.

H412 Harmful to aquatic life with long lasting effects.
1 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Precautionary statements : Prevention:

P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P273 Avoid release to the environment.
P280 Wear protective gloves.
Response:
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P362 + P364 Take off contaminated clothing and wash it
before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
2.3 Other hazards

See SECTION 3
SECTION 3: Composition/information on ingredients
Bottle 1
Classification (REGULATION (EC) No 1272/2008)
Skin sensitisation, Category 1 H317: May cause an allergic skin reaction.
Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef-
egory 3 fects.
Chemical nature : Handle as potentially infectious.
Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
Citric acid monohydrate 5949-29-1 Eye Irrit. 2; H319 >= 1,0 - < 10,0
201-069-1
01-2119457026-42
2-methyl-2H-isothiazol-3-one hy- 26172-54-3 Acute Tox. 3; H301 >= 0,25 - < 1,0
drochloride 247-499-3 Acute Tox. 2; H330
01-2120764168-47 Acute Tox. 3; H311
Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
EUH071
2 / 27
SAFETY DATA SHEET
HCG+ß CalSet
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
specific concentration
limit
Skin Sens. 1A; H317
>= 0,0015 %
For explanation of abbreviations see section 16.
Bottle 2
Classification (REGULATION (EC) No 1272/2008)
Skin sensitisation, Category 1 H317: May cause an allergic skin reaction.
Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef-
egory 3 fects.
Chemical nature : Handle as potentially infectious.
Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
Citric acid monohydrate 5949-29-1 Eye Irrit. 2; H319 >= 1,0 - < 10,0
201-069-1
01-2119457026-42
2-methyl-2H-isothiazol-3-one hy- 26172-54-3 Acute Tox. 3; H301 >= 0,25 - < 1,0
drochloride 247-499-3 Acute Tox. 2; H330
01-2120764168-47 Acute Tox. 3; H311
Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
EUH071
M-Factor (Acute
M-Factor (Chronic
specific concentration
limit
Skin Sens. 1A; H317
3 / 27
SAFETY DATA SHEET
HCG+ß CalSet
>= 0,0015 %
For explanation of abbreviations see section 16.
SECTION 4: First aid measures
4.1 Description of first aid measures

General advice : Move out of dangerous area.
Show this safety data sheet to the doctor in attendance.
Do not leave the victim unattended.
If inhaled : Move to fresh air.

If unconscious, place in recovery position and seek medical
advice.
If symptoms persist, call a physician.
In case of skin contact : If on skin, rinse well with water.
In case of eye contact : Immediately flush eye(s) with plenty of water.

Remove contact lenses.
Protect unharmed eye.
Keep eye wide open while rinsing.
If eye irritation persists, consult a specialist.
If swallowed : Keep respiratory tract clear.

Do not give milk or alcoholic beverages.
Never give anything by mouth to an unconscious person.
If symptoms persist, call a physician.
Rinse mouth with water.
4.2 Most important symptoms and effects, both acute and delayed
None known.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment : The first aid procedure should be established in consultation
with the doctor responsible for industrial medicine.
SECTION 5: Firefighting measures
5.1 Extinguishing media

Suitable extinguishing media : Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.
Unsuitable extinguishing : High volume water jet

media
5.2 Special hazards arising from the substance or mixture

Specific hazards during fire- : Do not allow run-off from fire fighting to enter drains or water
fighting courses.
4 / 27
SAFETY DATA SHEET
HCG+ß CalSet
5.3 Advice for firefighters

Special protective equipment : Wear self-contained breathing apparatus for firefighting if nec-
for firefighters essary.
Further information : Collect contaminated fire extinguishing water separately. This

must not be discharged into drains.
Fire residues and contaminated fire extinguishing water must
be disposed of in accordance with local regulations.
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures

Personal precautions : Use personal protective equipment.
Avoid dust formation.
Avoid breathing dust.
6.2 Environmental precautions

Environmental precautions : Prevent product from entering drains.
Prevent further leakage or spillage if safe to do so.
6.3 Methods and material for containment and cleaning up

Methods for cleaning up : Keep in suitable, closed containers for disposal.
6.4 Reference to other sections

Treat recovered material as described in the section "Disposal considerations".
SECTION 7: Handling and storage
7.1 Precautions for safe handling

Advice on safe handling : Avoid formation of respirable particles.
Do not breathe vapours/dust.
Avoid exposure - obtain special instructions before use.
Avoid contact with skin and eyes.
For personal protection see section 8.
Smoking, eating and drinking should be prohibited in the ap-
plication area.
Dispose of rinse water in accordance with local and national
regulations.
Persons susceptible to skin sensitisation problems or asthma,
allergies, chronic or recurrent respiratory disease should not
be employed in any process in which this mixture is being
used.
Advice on protection against : Avoid dust formation. Provide appropriate exhaust ventilation
fire and explosion at places where dust is formed.
Hygiene measures : Wash hands before breaks and at the end of workday.
5 / 27
SAFETY DATA SHEET
HCG+ß CalSet
7.2 Conditions for safe storage, including any incompatibilities

Requirements for storage : Keep container tightly closed in a dry and well-ventilated
areas and containers place. Containers which are opened must be carefully re-
sealed and kept upright to prevent leakage. Electrical installa-
tions / working materials must comply with the technological
safety standards.
Further information on stor- : See label, package insert or internal guidelines

age conditions
Storage class (TRGS 510) : 11, Combustible Solids
Further information on stor- : No decomposition if stored and applied as directed.

age stability
7.3 Specific end use(s)
Specific use(s) : Laboratory chemicals
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Bottle 1
Occupational Exposure Limits
Components CAS-No. Value type (Form Control parameters Basis
of exposure)
Citric acid mono- 5949-29-1 AGW (Inhalable 2 mg/m3 DE TRGS
hydrate fraction) 900
Peak-limit: excursion factor (category): 2;(I)
Further information: When there is compliance with the OEL and biological
tolerance values, there is no risk of harming the unborn child
Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance name Environmental Compartment Value
Citric acid monohydrate Fresh water 0,44 mg/l
Marine water 0,044 mg/l
Fresh water sediment 7,52 mg/kg
Marine sediment 0,752 mg/kg
Soil 29,2 mg/kg
Bottle 2
Occupational Exposure Limits
Components CAS-No. Value type (Form Control parameters Basis
of exposure)
Citric acid mono- 5949-29-1 AGW (Inhalable 2 mg/m3 DE TRGS
hydrate fraction) 900
Peak-limit: excursion factor (category): 2;(I)
Further information: When there is compliance with the OEL and biological
tolerance values, there is no risk of harming the unborn child
6 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:

Substance name Environmental Compartment Value
Citric acid monohydrate Fresh water 0,44 mg/l
Marine water 0,044 mg/l
Fresh water sediment 7,52 mg/kg
Marine sediment 0,752 mg/kg
Soil 29,2 mg/kg
8.2 Exposure controls
Engineering measures
No data available
Personal protective equipment
Eye protection : Eye wash bottle with pure water
Tightly fitting safety goggles
Use eye protection according to EN 166.
Hand protection
In case of contact through splashing:
Material : Nitrile rubber
Break through time : > 30 min
Glove thickness : > 0,11 mm
In case of full contact:

Material : butyl-rubber
Break through time : > 480 min
Glove thickness : > 0,4 mm
Remarks : The selected protective gloves have to satisfy the specifica-

tions of Regulation (EU) 2016/425 and the standard EN 374
derived from it. This recommendation is only valid for the
product mentioned in the safety data sheet and provided by
us and for the application specified by us. Please observe the
instructions regarding permeability and breakthrough time
which are provided by the supplier of the gloves. Also take
into consideration the specific local conditions under which
the product is used, such as the danger of cuts, abrasion,
and the contact time. The suitability for a specific workplace
should be discussed with the producers of the protective
gloves.
Skin and body protection : Choose body protection according to the amount and con-
centration of the dangerous substance at the work place.
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties

Bottle 1
Physical state : (lyophilised)
Colour : white
7 / 27
SAFETY DATA SHEET
HCG+ß CalSet
light yellow
Odour : none
Odour Threshold : Not applicable
Melting point/range : No data available
Boiling point/boiling range : No data available
Flammability : Sustains combustion
Upper explosion limit / Upper : No data available

flammability limit
Lower explosion limit / Lower : No data available

flammability limit
Flash point : does not flash
Auto-ignition temperature : No data available
Decomposition temperature : No data available
pH : 5,4 - 5,8
(as aqueous solution)
Viscosity
Viscosity, dynamic : Not applicable
Viscosity, kinematic : Not applicable
Solubility(ies)
Water solubility : completely soluble
Solubility in other solvents : No data available
Partition coefficient: n- : No data available

octanol/water
Vapour pressure : No data available
Relative density : No data available
Relative vapour density : Not applicable
Bottle 2
Physical state : (lyophilised)
Colour : white
light yellow
8 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Odour : none
Odour Threshold : Not applicable
Melting point/range : No data available
Boiling point/boiling range : No data available
Flammability : Sustains combustion
Upper explosion limit / Upper : No data available

flammability limit
Lower explosion limit / Lower : No data available

flammability limit
Flash point : does not flash
Auto-ignition temperature : No data available
Decomposition temperature : No data available
pH : 5,4 - 5,8
(as aqueous solution)
Viscosity
Viscosity, dynamic : Not applicable
Viscosity, kinematic : Not applicable
Solubility(ies)
Water solubility : completely soluble
Solubility in other solvents : No data available
Partition coefficient: n- : No data available

octanol/water
Vapour pressure : No data available
Relative density : No data available
Relative vapour density : Not applicable
9.2 Other information

Bottle 1
Oxidizing properties : The substance or mixture is not classified as oxidizing.
Flammability (liquids) : Sustains combustion
9 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Self-ignition : No data available
Evaporation rate : No data available
Bottle 2
Oxidizing properties : The substance or mixture is not classified as oxidizing.
Flammability (liquids) : Sustains combustion
Self-ignition : No data available
Evaporation rate : No data available
SECTION 10: Stability and reactivity
10.1 Reactivity
No dangerous reaction known under conditions of normal use.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions : No dangerous reaction known under conditions of normal use.
No decomposition if stored and applied as directed.
10.4 Conditions to avoid

Conditions to avoid : Exposure to moisture
10.5 Incompatible materials

Materials to avoid : Strong oxidizing agents
10.6 Hazardous decomposition products

No decomposition if stored and applied as directed.
SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008

Bottle 1
Acute toxicity
Not classified based on available information.
Components:
Citric acid monohydrate:

Acute oral toxicity : LD50 Oral (Mouse): 5.400 mg/kg
10 / 27
SAFETY DATA SHEET
HCG+ß CalSet
LD50 Oral (Rat): 3.000 mg/kg
LD50 Oral (Rabbit): > 7.000 mg/kg
Acute dermal toxicity : LD50 Dermal (Rat): > 2.000 mg/kg

Method: OECD Test Guideline 402
2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Acute inhalation toxicity : LC50 (Rat): 0,11 mg/l

Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: Corrosive to the respiratory tract.
Acute dermal toxicity : LD50 Dermal (Rat): 242 mg/kg

Skin corrosion/irritation
Components:

Species : Rabbit
Method : OECD Test Guideline 404
Result : No skin irritation
Species : reconstructed human epidermis (RhE)
Result : Causes severe burns.
Serious eye damage/eye irritation

Components:

Result : Irritating to eyes.
Respiratory or skin sensitisation
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
11 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Components:

Assessment : Did not cause sensitisation on laboratory animals.
Test Type : Local lymph node assay (LLNA)
Assessment : May cause sensitisation by skin contact.
Result : The product is a skin sensitiser, sub-category 1A.
Test Type : Maximisation Test

Species : Guinea pig
Result : positive
Germ cell mutagenicity

Components:

Genotoxicity in vitro : Test Type: reverse mutation assay
Result: negative
Genotoxicity in vivo : Test Type: Chromosome aberration test in vitro

Result: negative
Genotoxicity in vitro : Test Type: Ames test
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Result: negative
Test Type: In vitro mammalian cell gene mutation test

Test system: Chinese hamster ovary cells
Result: negative
Genotoxicity in vivo : Test Type: Micronucleus test

Species: Mouse (male and female)
Application Route: Oral
Result: negative
Test Type: unscheduled DNA synthesis assay

Species: Rat (male and female)
Result: negative
12 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Carcinogenicity
Components:
Remarks : No data available
Reproductive toxicity
Components:
Effects on foetal develop- : Species: Rat
ment Application Route: Oral
Dose: 40 mg/kg bw/day
Result: No effects on foetal development
STOT - single exposure

STOT - repeated exposure
Repeated dose toxicity
Components:
Species : Rat
NOEL : 94 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Remarks : No significant adverse effects were reported
No human information is available.
Species : Dog
NOAEL : 40,9 mg/kg bw/day
Aspiration toxicity
Bottle 2
Acute toxicity
Components:

Acute oral toxicity : LD50 Oral (Mouse): 5.400 mg/kg
13 / 27
SAFETY DATA SHEET
HCG+ß CalSet
LD50 Oral (Rat): 3.000 mg/kg
LD50 Oral (Rabbit): > 7.000 mg/kg
Acute dermal toxicity : LD50 Dermal (Rat): > 2.000 mg/kg

Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Acute inhalation toxicity : LC50 (Rat): 0,11 mg/l

Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: Corrosive to the respiratory tract.
Acute dermal toxicity : LD50 Dermal (Rat): 242 mg/kg

Skin corrosion/irritation
Components:

Species : Rabbit
Result : No skin irritation
Species : reconstructed human epidermis (RhE)
Result : Causes severe burns.
Serious eye damage/eye irritation

Components:

Result : Irritating to eyes.
Respiratory or skin sensitisation
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
14 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Components:

Assessment : Did not cause sensitisation on laboratory animals.
Test Type : Local lymph node assay (LLNA)
Assessment : May cause sensitisation by skin contact.
Result : The product is a skin sensitiser, sub-category 1A.
Test Type : Maximisation Test

Species : Guinea pig
Result : positive
Germ cell mutagenicity

Components:

Genotoxicity in vitro : Test Type: reverse mutation assay
Result: negative
Genotoxicity in vivo : Test Type: Chromosome aberration test in vitro

Result: negative
Genotoxicity in vitro : Test Type: Ames test
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Result: negative
Test Type: In vitro mammalian cell gene mutation test

Test system: Chinese hamster ovary cells
Result: negative
Genotoxicity in vivo : Test Type: Micronucleus test

Species: Mouse (male and female)
Result: negative
Test Type: unscheduled DNA synthesis assay

Species: Rat (male and female)
Result: negative
15 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Carcinogenicity
Components:
Remarks : No data available
Reproductive toxicity
Components:
Effects on foetal develop- : Species: Rat
ment Application Route: Oral
Dose: 40 mg/kg bw/day
Result: No effects on foetal development
STOT - single exposure

STOT - repeated exposure
Repeated dose toxicity
Components:
Species : Rat
NOEL : 94 mg/kg bw/day
Remarks : No significant adverse effects were reported
No human information is available.
Species : Dog
NOAEL : 40,9 mg/kg bw/day
Aspiration toxicity
11.2 Information on other hazards
Bottle 1
Endocrine disrupting properties
No data available
Bottle 2
16 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Endocrine disrupting properties

No data available
SECTION 12: Ecological information
12.1 Toxicity
Bottle 1
Components:

Toxicity to fish : LC0 (Carassius auratus (goldfish)): 625 mg/l
LC50 (Leuciscus idus (Golden orfe)): 440 mg/l

Exposure time: 48 h
Test Type: static test
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 120 mg/l
aquatic invertebrates Exposure time: 72 h
LC50 (Daphnia magna (Water flea)): 1.535 mg/l

Exposure time: 24 h
Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.
Chronic aquatic toxicity : This product has no known ecotoxicological effects.
Toxicity Data on Soil : Not expected to adsorb on soil.
Other organisms relevant to : No data available

the environment
Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): 4,77 mg/l
Exposure time: 96 h
Test Type: flow-through test
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 2,33 mg/l
NOEC (Daphnia magna (Water flea)): 0,9 mg/l

Exposure time: 48 h
EC50 (Daphnia magna (Water flea)): 0,998 mg/l
17 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Exposure time: 48 h
Toxicity to algae/aquatic : ErC50 (Pseudokirchneriella subcapitata (green algae)): 0,289

plants mg/l
Exposure time: 72 h
NOEC (Pseudokirchneriella subcapitata (green algae)): 0,047

mg/l
Exposure time: 72 h
M-Factor (Acute aquatic tox- : 1

icity)
Toxicity to fish (Chronic tox- : NOEC: 2,38 mg/l

icity) Exposure time: 98 d
Species: Oncorhynchus mykiss (rainbow trout)
Toxicity to daphnia and other : NOEC: 0,0442 mg/l

aquatic invertebrates (Chron- Exposure time: 21 d
ic toxicity) Species: Daphnia magna (Water flea)
M-Factor (Chronic aquatic : 1

toxicity)
Bottle 2
Components:

Toxicity to fish : LC0 (Carassius auratus (goldfish)): 625 mg/l
LC50 (Leuciscus idus (Golden orfe)): 440 mg/l

Exposure time: 48 h
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 120 mg/l
LC50 (Daphnia magna (Water flea)): 1.535 mg/l

Exposure time: 24 h
Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.
Chronic aquatic toxicity : This product has no known ecotoxicological effects.
18 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Toxicity Data on Soil : Not expected to adsorb on soil.
Other organisms relevant to : No data available

the environment
Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): 4,77 mg/l
Exposure time: 96 h
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 2,33 mg/l
NOEC (Daphnia magna (Water flea)): 0,9 mg/l

Exposure time: 48 h
EC50 (Daphnia magna (Water flea)): 0,998 mg/l

Exposure time: 48 h
Toxicity to algae/aquatic : ErC50 (Pseudokirchneriella subcapitata (green algae)): 0,289

plants mg/l
Exposure time: 72 h
NOEC (Pseudokirchneriella subcapitata (green algae)): 0,047

mg/l
Exposure time: 72 h
M-Factor (Acute aquatic tox- : 1

icity)
Toxicity to fish (Chronic tox- : NOEC: 2,38 mg/l

icity) Exposure time: 98 d
Species: Oncorhynchus mykiss (rainbow trout)
Toxicity to daphnia and other : NOEC: 0,0442 mg/l

aquatic invertebrates (Chron- Exposure time: 21 d
ic toxicity) Species: Daphnia magna (Water flea)
M-Factor (Chronic aquatic : 1

toxicity)
19 / 27
SAFETY DATA SHEET
HCG+ß CalSet
12.2 Persistence and degradability

Bottle 1
Components:

Biodegradability : Result: Readily biodegradable.
Biodegradation: 97 %
Exposure time: 28 d
Method: OECD Test Guideline 301B
Remarks: Expected to be ultimately biodegradable
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
Bottle 2
Components:

Biodegradability : Result: Readily biodegradable.
Biodegradation: 97 %
Exposure time: 28 d
Remarks: Expected to be ultimately biodegradable
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
12.3 Bioaccumulative potential

Bottle 1
Components:

Bioaccumulation : Remarks: Bioaccumulation is unlikely.
Partition coefficient: n- : log Pow: 1,72

octanol/water
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
20 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Partition coefficient: n- : log Pow: ca. -0,44 (20 °C)

octanol/water Method: OECD Test Guideline 107
Bottle 2
Components:

Bioaccumulation : Remarks: Bioaccumulation is unlikely.
Partition coefficient: n- : log Pow: 1,72

octanol/water
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
Partition coefficient: n- : log Pow: ca. -0,44 (20 °C)

octanol/water Method: OECD Test Guideline 107
12.4 Mobility in soil

Bottle 1
No data available
Bottle 2
No data available
12.5 Results of PBT and vPvB assessment
Bottle 1
Not relevant
Bottle 2
Not relevant
12.6 Endocrine disrupting properties
Bottle 1
No data available
Bottle 2
No data available
12.7 Other adverse effects
Bottle 1
No data available
Bottle 2
No data available
SECTION 13: Disposal considerations
13.1 Waste treatment methods
21 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Product : Special treatment as infectious material is mandatory in com-

pliance with local regulations (disinfection and incineration).
The product should not be allowed to enter drains, water
courses or the soil.
Do not contaminate ponds, waterways or ditches with chemi-
cal or used container.
Send to a licensed waste management company.
Can be disposed as waste water, when in compliance with
local regulations.
Contaminated packaging : Empty remaining contents.

Dispose of as unused product.
Empty containers should be taken to an approved waste han-
dling site for recycling or disposal.
Do not re-use empty containers.
SECTION 14: Transport information
14.1 UN number or ID number

Not regulated as a dangerous good
14.2 UN proper shipping name
14.3 Transport hazard class(es)
14.4 Packing group
14.5 Environmental hazards
14.6 Special precautions for user
Remarks : Not dangerous goods in the meaning of ADR/RID, ADN,
IMDG-Code, ICAO/IATA-DGR
14.7 Maritime transport in bulk according to IMO instruments

Remarks : Not applicable
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-
ture
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control of
major-accident hazards involving dangerous substances.
Not applicable
Water contaminating class : WGK 2 obviously hazardous to water

(Germany)
22 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Bottle 1
REACH - Restrictions on the manufacture, placing on : Not applicable
the market and use of certain dangerous substances,
preparations and articles (Annex XVII)
REACH - Candidate List of Substances of Very High : Not applicable

Concern for Authorisation (Article 59).
REACH - List of substances subject to authorisation : Not applicable

(Annex XIV)
Regulation (EC) No 1005/2009 on substances that de- : Not applicable

plete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu- : Not applicable

tants (recast)
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable

ment and the Council concerning the export and import
of dangerous chemicals
Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:

AIIC : Not in compliance with the inventory
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.
Human serum /-plasma / -hemolysate, lyophilized

hydroxyl-2-pyridone
NZIoC : Not in compliance with the inventory
ENCS : Not in compliance with the inventory
ISHL : Not in compliance with the inventory
KECI : Not in compliance with the inventory
PICCS : Not in compliance with the inventory
IECSC : Not in compliance with the inventory
TCSI : Not in compliance with the inventory
TSCA : Product contains substance(s) not listed on TSCA inventory.
Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial

emissions (integrated pollution prevention and control)
Not applicable
23 / 27
SAFETY DATA SHEET
HCG+ß CalSet

Hazard pictograms :


Response:
advice/ attention.
before reuse.
Disposal:
disposal plant.
Hazardous components which must be listed on the label:

26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride
Bottle 2
REACH - Restrictions on the manufacture, placing on : Not applicable
the market and use of certain dangerous substances,
preparations and articles (Annex XVII)
REACH - Candidate List of Substances of Very High : Not applicable

Concern for Authorisation (Article 59).
REACH - List of substances subject to authorisation : Not applicable

(Annex XIV)
Regulation (EC) No 1005/2009 on substances that de- : Not applicable

plete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu- : Not applicable

tants (recast)
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable

ment and the Council concerning the export and import
of dangerous chemicals
Other regulations:
24 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:

AIIC : Not in compliance with the inventory
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.
Human serum /-plasma / -hemolysate, lyophilized

hydroxyl-2-pyridone
NZIoC : Not in compliance with the inventory
ENCS : Not in compliance with the inventory
ISHL : Not in compliance with the inventory
KECI : Not in compliance with the inventory
PICCS : Not in compliance with the inventory
IECSC : Not in compliance with the inventory
TCSI : Not in compliance with the inventory
TSCA : Product contains substance(s) not listed on TSCA inventory.
Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial

emissions (integrated pollution prevention and control)
Not applicable

Hazard pictograms :


Response:
advice/ attention.
before reuse.
25 / 27
SAFETY DATA SHEET
HCG+ß CalSet
Disposal:
disposal plant.
Hazardous components which must be listed on the label:

26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride
15.2 Chemical safety assessment

Chemical Safety Assessments for all substances in this product are either Complete or Not appli-
cable.
SECTION 16: Other information
Full text of H-Statements

H301 : Toxic if swallowed.
H311 : Toxic in contact with skin.
H314 : Causes severe skin burns and eye damage.
H317 : May cause an allergic skin reaction.
H318 : Causes serious eye damage.
H319 : Causes serious eye irritation.
H330 : Fatal if inhaled.
H400 : Very toxic to aquatic life.
H410 : Very toxic to aquatic life with long lasting effects.
Full text of other abbreviations
Acute Tox. : Acute toxicity
Aquatic Acute : Short-term (acute) aquatic hazard
Aquatic Chronic : Long-term (chronic) aquatic hazard
Eye Dam. : Serious eye damage
Eye Irrit. : Eye irritation
Skin Corr. : Skin corrosion
Skin Sens. : Skin sensitisation
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - European Agreement concerning the International Carriage of Dangerous
Goods by Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for
the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation;
Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN -
Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada);
ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Con-
centration associated with x% response; ELx - Loading rate associated with x% response; EmS -
Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concen-
tration associated with x% growth rate response; GHS - Globally Harmonized System; GLP -
Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - Interna-
tional Air Transport Association; IBC - International Code for the Construction and Equipment of
Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO
- International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in
China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organiza-
tion; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Stand-
ardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a
test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL -
International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Speci-
26 / 27
SAFETY DATA SHEET
HCG+ß CalSet
fied; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse)

Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of
Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office
of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic sub-
stance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti-
tative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Re-
striction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TRGS -
Technical Rule for Hazardous Substances; TSCA - Toxic Substances Control Act (United States);
UN - United Nations; vPvB - Very Persistent and Very Bioaccumulative
Further information
The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor-
mation and belief at the date of its publication. The information given is designed only as a guid-
ance for safe handling, use, processing, storage, transportation, disposal and release and is not
to be considered a warranty or quality specification. The information relates only to the specific
material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text.
DE / EN / 2010
27 / 27

HCG+SS Calset: Safety Data Sheet

Uploaded by

Copyright:

Available Formats

HCG+SS Calset: Safety Data Sheet

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

HCG+SS Calset: Safety Data Sheet

Uploaded by

Copyright:

Available Formats

SAFETY DATA SHEET

according to Regulation (EC) No. 1907/2006

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier

Product code : 03302652190

1.3 Details of the supplier of the safety data sheet

Centre for detoxification: : Mainz +49(0)6131-19240

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

2.2 Label elements

Labelling (REGULATION (EC) No 1272/2008)

Signal word : Warning

Hazard statements : H317 May cause an allergic skin reaction.

Precautionary statements : Prevention:

2.3 Other hazards

SECTION 3: Composition/information on ingredients

Chemical nature : Handle as potentially infectious.

For explanation of abbreviations see section 16.

Chemical nature : Handle as potentially infectious.

For explanation of abbreviations see section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures

If inhaled : Move to fresh air.

In case of skin contact : If on skin, rinse well with water.

In case of eye contact : Immediately flush eye(s) with plenty of water.

If swallowed : Keep respiratory tract clear.

SECTION 5: Firefighting measures

5.1 Extinguishing media

Unsuitable extinguishing : High volume water jet

5.2 Special hazards arising from the substance or mixture

5.3 Advice for firefighters

Further information : Collect contaminated fire extinguishing water separately. This

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

6.2 Environmental precautions

6.3 Methods and material for containment and cleaning up

6.4 Reference to other sections

SECTION 7: Handling and storage

7.1 Precautions for safe handling

7.2 Conditions for safe storage, including any incompatibilities

Further information on stor- : See label, package insert or internal guidelines

Storage class (TRGS 510) : 11, Combustible Solids

Further information on stor- : No decomposition if stored and applied as directed.

SECTION 8: Exposure controls/personal protection

8.1 Control parameters

Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:

Use eye protection according to EN 166.

In case of full contact:

Remarks : The selected protective gloves have to satisfy the specifica-

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

Odour Threshold : Not applicable

Melting point/range : No data available

Boiling point/boiling range : No data available

Flammability : Sustains combustion

Upper explosion limit / Upper : No data available

Lower explosion limit / Lower : No data available

Flash point : does not flash