according to Regulation (EC) No.

1907/2006 (REACH) with its amendment Regulation (EU) 2015/830

15/02/2016
301415 Alere Afinion™ CRP
Version: 2.0

Safety Data Sheet

Alere Afinion™ CRP

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

1.1. Product identifier
Product name : Alere Afinion™ CRP Part 1: Conjugate

1.2. Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses
Main use category : Professional use
Use of the substance/mixture : In Vitro Diagnostic Medical Device

Uses advised against

No additional information available
1.3. Details of the supplier of the safety data sheet
Supplier Manufacturer
Alere Technologies AS Alere Technologies AS
Kjelsåsveien 161, P.O. Box 6863 Rodeløkka Kjelsåsveien 161, P.O. Box 6863 Rodeløkka
NO-0504 Oslo - Norway NO-0504 Oslo - Norway
T +47-24056000 - F +47-24056010 T +47-24056000 - F +47-24056010
[email protected] - www.alere.com [email protected] - www.alere.com

1.4. Emergency telephone number

Country Organisation/Company Address Emergency number
United Kingdom National Poisons Information Service (Newcastle Claremont Place +44 191 2606182/+44 191
Newcastle-upon-Tyne, Newcastle
Unit) 2606180 24H

SECTION 2: HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP]
Not classified

2.2. Label elements

Labelling according to Regulation (EC) No. 1272/2008 [CLP]
EUH-statements : EUH210 - Safety data sheet available on request
Extra phrases : In vitro diagnostic medical devices, EU-regulation 1272/2008/EC, article 1, paragraph 5d

2.3. Other hazards

Other hazards not contributing to the : None under normal conditions.
classification
This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1. Substance
Not applicable

3.2. Mixture
Comment : None of the other components are subject to classification, or are present in quantities
above regulatory disclosure limits

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301415 Alere Afinion™ CRP 15/02/2016

Name Product identifier % Classification according to

Regulation (EC) No.
1272/2008 [CLP]
boric acid (CAS No) 10043-35-3 < 0.3 Repr. 1B, H360FD
substance listed as REACH Candidate (EC no) 233-139-2
(EC index no) 005-007-00-2
disodium tetraborate, anhydrous, boric acid, disodium salt (CAS No) 1330-43-4 < 0.3 Repr. 1B, H360FD
substance listed as REACH Candidate (Disodium tetraborate, (EC no) 215-540-4
anhydrous) (EC index no) 005-011-00-4

Specific concentration limits:

Name Product identifier Specific concentration limits
boric acid (CAS No) 10043-35-3 (C >= 5.5) Repr. 1B, H360FD
(EC no) 233-139-2
(EC index no) 005-007-00-2
disodium tetraborate, anhydrous, boric acid, disodium salt (CAS No) 1330-43-4 (C >= 4.5) Repr. 1B, H360FD
(EC no) 215-540-4
(EC index no) 005-011-00-4

Full text of H-statements: see section 16

SECTION 4: FIRST AID MEASURES

4.1. Description of first aid measures
First-aid measures general : The reagents are in a sealed test cartridge and designated first aid measures are actual
only if the device is leaking.
First-aid measures after inhalation : No specific first aid measures noted.
First-aid measures after skin contact : Remove affected clothing and wash all exposed skin area with mild soap and water,
followed by warm water rinse.
First-aid measures after eye contact : Immediately flush with plenty of water or eyewash solution for up to 10 minutes. Obtain
medical attention if pain, blinking or redness persist.
First-aid measures after ingestion : If swallowed, rinse mouth with water (only if the person is conscious). Drink a few glasses of
water or milk. Call a poison center or a doctor if you feel unwell.
4.2. Most important symptoms and effects, both acute and delayed
Symptoms/injuries : Not expected to present a significant hazard under anticipated conditions of normal use.
4.3. Indication of any immediate medical attention and special treatment needed
In all cases of doubt, or when symptoms persist, seek medical attention.

SECTION 5: FIREFIGHTING MEASURES

5.1. Extinguishing media
Suitable extinguishing media : Use extinguishing media appropriate for surrounding fire.
Unsuitable extinguishing media : None to our knowledge.
5.2. Special hazards arising from the substance or mixture
Fire hazard : Non flammable.
5.3. Advice for firefighters
Firefighting instructions : Use water spray or fog for cooling exposed containers. Exercise caution when fighting any
chemical fire. Avoid (reject) fire-fighting water to enter environment.
Protection during firefighting : Do not enter fire area without proper personal protective equipment, including respiratory
protection.

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1. Personal precautions, protective equipment and emergency procedures
General measures : Wear appropriate personal protective equipment - see Section 8.

For non-emergency personnel

Emergency procedures : Evacuate unnecessary personnel.

For emergency responders

Protective equipment : Equip cleanup crew with proper protection.
6.2. Environmental precautions
Prevent entry to sewers and public waters. Notify authorities if liquid enters sewers or public waters.
6.3. Methods and material for containment and cleaning up
Methods for cleaning up : Take up liquid spill into absorbent material. The contaminated area should be cleaned up
immediately with a suitable decontaminant.

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301415 Alere Afinion™ CRP 15/02/2016

6.4. Reference to other sections

See section 13 for waste handling. For further information refer to section 8: "Exposure controls/personal protection".

SECTION 7: HANDLING AND STORAGE

7.1. Precautions for safe handling
Precautions for safe handling : Avoid contact with skin and eyes. Wash hands and other exposed areas with mild soap and
water before eating, drinking or smoking and when leaving work. Wear appropriate personal
protective equipment - see Section 8.
7.2. Conditions for safe storage, including any incompatibilities
Incompatible materials : Sources of ignition. Direct sunlight.
Storage temperature : 2 - 8 °C (36 - 46°F)
7.3. Specific end use(s)
For professional use only.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1. Control parameters
sodium azide (26628-22-8)
United Kingdom Local name Sodium azide (as NaN3 )
United Kingdom WEL TWA (mg/m³) 0.1 mg/m³
United Kingdom WEL STEL (mg/m³) 0.3 mg/m³
United Kingdom Remark (WEL) Sk (Can be absorbed through the skin. The assigned
substances are those for which there are concerns
that dermal absorption will lead to systemic toxicity)

8.2. Exposure controls

Appropriate engineering controls : Provide eyewash station.
Hand protection : Wear suitable gloves resistant to chemical penetration. Neoprene or nitrile rubber gloves.
Layer thickness : 0,10mm. Breakthrough time : >480 min. STANDARD EN 374
Eye protection : Not necessary under the recommended storage and handling conditions. Use splash
goggles when eye contact due to splashing is possible. STANDARD EN 166
Skin and body protection : Lab coat
Respiratory protection : Respiratory protection not applicable
Other information : Personal protective equipment should be chosen according to the CEN standards and in
discussion with the supplier of the protective equipment. Do not eat, drink or smoke during
use.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1. Information on basic physical and chemical properties
Physical state : Liquid
Colour : Red.
Odour : No data available
Odour threshold : No data available
pH : 8.5
Relative evaporation rate (butylacetate=1) : No data available
Melting point : No data available
Freezing point : No data available
Boiling point : No data available
Flash point : No data available
Auto-ignition temperature : No data available
Decomposition temperature : No data available
Flammability (solid, gas) : Non flammable
Vapour pressure : No data available
Relative vapour density at 20 °C : No data available
Relative density : No data available
Solubility : Soluble in water.
Log Pow : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available

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Explosive properties : Not explosive.
Oxidising properties : Non flammable.
Explosive limits : No data available

9.2. Other information

Additional information : None to our knowledge.

SECTION 10: STABILITY AND REACTIVITY

10.1. Reactivity
Stable under normal conditions.
10.2. Chemical stability
Stable under normal conditions of use.
10.3. Possibility of hazardous reactions
Not established.
10.4. Conditions to avoid
Avoid strong heating.
10.5. Incompatible materials
None to our knowledge.
10.6. Hazardous decomposition products
No decomposition if stored normally.

SECTION 11: TOXICOLOGICAL INFORMATION

11.1. Information on toxicological effects
Acute toxicity : Ingestion may cause nausea and vomiting

boric acid (10043-35-3)

LD50 oral rat 2660 mg/kg
LD50 dermal rabbit > 2000 mg/kg
LC50 inhalation rat (mg/l) > 0.028 mg/l/4h
sodium azide (26628-22-8)
LD50 oral rat 27 mg/kg
LD50 dermal rat 50 mg/kg
LD50 dermal rabbit 20 mg/kg
Skin corrosion/irritation : Slight skin irritant
pH: 8.5
Serious eye damage/irritation : Liquid splashes in the eye may cause irritation
pH: 8.5
Respiratory or skin sensitisation : Not classified
Germ cell mutagenicity : Not classified
Carcinogenicity : Not classified
Reproductive toxicity : Not classified
Specific target organ toxicity (single exposure) : Not classified
Specific target organ toxicity (repeated : Not classified
exposure)
Aspiration hazard : Not classified

Potential adverse human health effects and : Low health hazard.

symptoms

SECTION 12: ECOLOGICAL INFORMATION

12.1. Toxicity
Ecology - general : The product is not considered harmful to aquatic organisms nor to cause long-term adverse
effects in the environment.

boric acid (10043-35-3)

LC50 fish 1 > 800 mg/l (96 hours - Rainbow trout)
EC50 Daphnia 1 10 mg/l
IC50 algae 192 mg/l
sodium azide (26628-22-8)
LC50 fish 1 0.7 mg/l (96 hours - Lepomis macrochirus)
EC50 Daphnia 1 4.2 mg/l (48 hours - Daphnia pulex)

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according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2015/830
301415 Alere Afinion™ CRP 15/02/2016

12.2. Persistence and degradability

Alere Afinion™ CRP
Persistence and degradability Biodegradability in water: no data available.

12.3. Bioaccumulative potential

Alere Afinion™ CRP
Bioaccumulative potential Bioaccumulation unlikely.
boric acid (10043-35-3)
Bioconcentration factor (BCF REACH) 0
Log Pow -1.09
12.4. Mobility in soil
Alere Afinion™ CRP
Ecology - soil No data available.

12.5. Results of PBT and vPvB assessment

Alere Afinion™ CRP
This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII
Component
boric acid (10043-35-3) This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII
disodium tetraborate, anhydrous, boric acid, This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
disodium salt (1330-43-4) This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII

12.6. Other adverse effects

Other adverse effects : None to our knowledge.
Additional information : Avoid release to the environment

SECTION 13: DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods
Regional legislation (waste) : Dispose of contents/container in accordance with licensed collector’s sorting instructions.
Used device to be handled as infectious.
Additional information : The given EWC-code is a guiding, and the code depends on how the waste is formed. User
must evaluate the choice of correct code.
Ecology - waste materials : Avoid release to the environment.
European List of Waste (LoW) code : 18 01 03* - wastes whose collection and disposal is subject to special requirements in order
to prevent infection

SECTION 14: TRANSPORT INFORMATION

In accordance with ADR / RID / IMDG / IATA / ADN

ADR IMDG IATA RID

14.1. UN number
Not regulated for transport
14.2. UN proper shipping name
Not applicable Not applicable Not applicable Not applicable
14.3. Transport hazard class(es)
Not applicable Not applicable Not applicable Not applicable
Not applicable Not applicable Not applicable Not applicable
14.4. Packing group
Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards

Dangerous for the Dangerous for the Dangerous for the environment : No Dangerous for the
environment : No environment : No environment : No
Marine pollutant : No
No supplementary information available

14.6. Special precautions for user

Special transport precautions : No particular precautions

- Overland transport
No data available

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- Transport by sea
No data available

- Air transport
No data available

Rail transport
No data available
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable

SECTION 15: REGULATORY INFORMATION

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU-Regulations

Contains no REACH substances with Annex XVII restrictions

Contains a substance on the REACH candidate list in concentration ≥ 0.1% or with a lower specific limit: Boric acid (EC 233-139-2, CAS 10043-35-
3), Disodium tetraborate, anhydrous (EC 215-540-4, CAS 1330-43-4)
Contains no REACH Annex XIV substances

National regulations
EC-regulation2015/830 /EC, 1907/2006/EC (REACH), 1272/2008/EC (CLP), 790/2009/EC. Transport of dangerous goods (ADR/RID, IMDG,
IATA/ICAO). Workplace exposure limits

15.2. Chemical safety assessment

No chemical safety assessment has been carried out

SECTION 16: OTHER INFORMATION

Indication of changes:
Unknown.
Data sources : EC-regulation2015/830 /EC, 1907/2006/EC (REACH), 1272/2008/EC (CLP), 790/2009/EC.
Transport of dangerous goods (ADR/RID, IMDG, IATA/ICAO). Workplace exposure limits.
Other information : None.
Date of issue : 30/11/2014
Revision date : 15/02/2016
Supersedes : 30/11/2014
Version : 2.0
Signature : K. Dyreskog
Full text of H- and EUH-statements:
Repr. 1B Reproductive toxicity, Category 1B
H360FD May damage fertility. May damage the unborn child
EUH210 Safety data sheet available on request

The information in this safety data sheet is based on information from the manufacturer/supplier, present European and national legislation, and presupposes that the product is used within the
specified area of application.

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according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2015/830

15/02/2016
301414 Alere Afinion™ CRP
Version: 2.0

Safety Data Sheet

Alere Afinion™ CRP

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

1.1. Product identifier
Product name : Alere Afinion™ CRP Part 2: Dilution Liquid, Washing Solution

1.2. Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses
Main use category : Professional use
Use of the substance/mixture : In Vitro Diagnostic Medical Device

Uses advised against

No additional information available
1.3. Details of the supplier of the safety data sheet
Supplier Manufacturer
Alere Technologies AS Alere Technologies AS
Kjelsåsveien 161, P.O. Box 6863 Rodeløkka Kjelsåsveien 161, P.O. Box 6863 Rodeløkka
NO-0504 Oslo - Norway NO-0504 Oslo - Norway
T +47-24056000 - F +47-24056010 T +47-24056000 - F +47-24056010
[email protected] - www.alere.com [email protected] - www.alere.com

1.4. Emergency telephone number

Country Organisation/Company Address Emergency number
United Kingdom National Poisons Information Service (Newcastle Claremont Place +44 191 2606182/+44 191
Newcastle-upon-Tyne, Newcastle
Unit) 2606180 24H

SECTION 2: HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP]
Not classified

2.2. Label elements

Labelling according to Regulation (EC) No. 1272/2008 [CLP]
EUH-statements : EUH210 - Safety data sheet available on request
Extra phrases : In vitro diagnostic medical devices, EU-regulation 1272/2008/EC, article 1, paragraph 5d

2.3. Other hazards

Other hazards not contributing to the : None under normal conditions.
classification
This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1. Substance
Not applicable

3.2. Mixture
Comment : None of the other components are subject to classification, or are present in quantities
above regulatory disclosure limits

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Name Product identifier % Classification according to

Regulation (EC) No.
1272/2008 [CLP]
Desoxycholic acidsodium salt (CAS No) 302-95-4 < 1.5 Acute Tox. 4 (Oral), H302
(EC no) 206-132-7 STOT SE 3, H335

Full text of H-statements: see section 16

SECTION 4: FIRST AID MEASURES

4.1. Description of first aid measures
First-aid measures general : The reagents are in a sealed test cartridge and designated first aid measures are actual
only if the device is leaking.
First-aid measures after inhalation : No specific first aid measures noted.
First-aid measures after skin contact : Remove affected clothing and wash all exposed skin area with mild soap and water,
followed by warm water rinse.
First-aid measures after eye contact : Immediately flush with plenty of water or eyewash solution for up to 10 minutes. Obtain
medical attention if pain, blinking or redness persist.
First-aid measures after ingestion : If swallowed, rinse mouth with water (only if the person is conscious). Drink a few glasses of
water or milk. Call a poison center or a doctor if you feel unwell.
4.2. Most important symptoms and effects, both acute and delayed
Symptoms/injuries : Not expected to present a significant hazard under anticipated conditions of normal use.
4.3. Indication of any immediate medical attention and special treatment needed
In all cases of doubt, or when symptoms persist, seek medical attention.

SECTION 5: FIREFIGHTING MEASURES

5.1. Extinguishing media
Suitable extinguishing media : Use extinguishing media appropriate for surrounding fire.
Unsuitable extinguishing media : None to our knowledge.
5.2. Special hazards arising from the substance or mixture
Fire hazard : Non flammable.
5.3. Advice for firefighters
Firefighting instructions : Use water spray or fog for cooling exposed containers. Exercise caution when fighting any
chemical fire. Avoid (reject) fire-fighting water to enter environment.
Protection during firefighting : Do not enter fire area without proper personal protective equipment, including respiratory
protection.

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1. Personal precautions, protective equipment and emergency procedures
General measures : Wear appropriate personal protective equipment - see Section 8.

For non-emergency personnel

Emergency procedures : Evacuate unnecessary personnel.

For emergency responders

Protective equipment : Equip cleanup crew with proper protection.
6.2. Environmental precautions
Prevent entry to sewers and public waters. Notify authorities if liquid enters sewers or public waters.
6.3. Methods and material for containment and cleaning up
Methods for cleaning up : Take up liquid spill into absorbent material. The contaminated area should be cleaned up
immediately with a suitable decontaminant.
6.4. Reference to other sections
See section 13 for waste handling. For further information refer to section 8: "Exposure controls/personal protection".

SECTION 7: HANDLING AND STORAGE

7.1. Precautions for safe handling
Precautions for safe handling : Avoid contact with skin and eyes. Wash hands and other exposed areas with mild soap and
water before eating, drinking or smoking and when leaving work. Wear appropriate personal
protective equipment - see Section 8.
7.2. Conditions for safe storage, including any incompatibilities
Incompatible materials : Sources of ignition. Direct sunlight.
Storage temperature : 2 - 8 °C (36 - 46°F)

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7.3. Specific end use(s)

For professional use only.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1. Control parameters
sodium azide (26628-22-8)
United Kingdom Local name Sodium azide (as NaN3 )
United Kingdom WEL TWA (mg/m³) 0.1 mg/m³
United Kingdom WEL STEL (mg/m³) 0.3 mg/m³
United Kingdom Remark (WEL) Sk (Can be absorbed through the skin. The assigned
substances are those for which there are concerns
that dermal absorption will lead to systemic toxicity)

8.2. Exposure controls

Appropriate engineering controls : Provide eyewash station.
Hand protection : Wear suitable gloves resistant to chemical penetration. Neoprene or nitrile rubber gloves.
Layer thickness : 0,10mm. Breakthrough time : >480 min. STANDARD EN 374
Eye protection : Not necessary under the recommended storage and handling conditions. Use splash
goggles when eye contact due to splashing is possible. STANDARD EN 166
Skin and body protection : Lab coat
Respiratory protection : Respiratory protection not applicable
Other information : Personal protective equipment should be chosen according to the CEN standards and in
discussion with the supplier of the protective equipment. Do not eat, drink or smoke during
use.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1. Information on basic physical and chemical properties
Physical state : Liquid
Colour : Colourless.
Odour : None.
Odour threshold : No data available
pH : 8.5 - 9
Relative evaporation rate (butylacetate=1) : No data available
Melting point : No data available
Freezing point : No data available
Boiling point : No data available
Flash point : No data available
Auto-ignition temperature : No data available
Decomposition temperature : No data available
Flammability (solid, gas) : Non flammable
Vapour pressure : No data available
Relative vapour density at 20 °C : No data available
Relative density : No data available
Solubility : Soluble in water.
Log Pow : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
Explosive properties : Not explosive.
Oxidising properties : Non flammable.
Explosive limits : No data available

9.2. Other information

Additional information : None to our knowledge.

SECTION 10: STABILITY AND REACTIVITY

10.1. Reactivity
Stable under normal conditions.
10.2. Chemical stability
Stable under normal conditions of use.

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10.3. Possibility of hazardous reactions

Not established.
10.4. Conditions to avoid
Avoid strong heating.
10.5. Incompatible materials
None to our knowledge.
10.6. Hazardous decomposition products
No decomposition if stored normally.

SECTION 11: TOXICOLOGICAL INFORMATION

11.1. Information on toxicological effects
Acute toxicity : Ingestion may cause nausea and vomiting

sodium azide (26628-22-8)

LD50 oral rat 27 mg/kg
LD50 dermal rat 50 mg/kg
LD50 dermal rabbit 20 mg/kg
Desoxycholic acidsodium salt (302-95-4)
LD50 oral rat 1370 mg/kg
Skin corrosion/irritation : Slight skin irritant
pH: 8.5 - 9
Serious eye damage/irritation : Liquid splashes in the eye may cause irritation
pH: 8.5 - 9
Respiratory or skin sensitisation : Not classified
Germ cell mutagenicity : Not classified
Carcinogenicity : Not classified
Reproductive toxicity : Not classified
Specific target organ toxicity (single exposure) : Not classified
Specific target organ toxicity (repeated : Not classified
exposure)
Aspiration hazard : Not classified

Potential adverse human health effects and : Low health hazard.

symptoms

SECTION 12: ECOLOGICAL INFORMATION

12.1. Toxicity
Ecology - general : The product is not considered harmful to aquatic organisms nor to cause long-term adverse
effects in the environment.

sodium azide (26628-22-8)

LC50 fish 1 0.7 mg/l (96 hours - Lepomis macrochirus)
EC50 Daphnia 1 4.2 mg/l (48 hours - Daphnia pulex)
Desoxycholic acidsodium salt (302-95-4)
LC50 fish 1 115 mg/l Oryzias latipes

12.2. Persistence and degradability

Alere Afinion™ CRP
Persistence and degradability Biodegradability in water: no data available.

12.3. Bioaccumulative potential

Alere Afinion™ CRP
Bioaccumulative potential Bioaccumulation unlikely.
Desoxycholic acidsodium salt (302-95-4)
Log Pow 5.06
12.4. Mobility in soil
Alere Afinion™ CRP
Ecology - soil No data available.

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301414 Alere Afinion™ CRP 15/02/2016

12.5. Results of PBT and vPvB assessment

Alere Afinion™ CRP
This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII
This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII

12.6. Other adverse effects

Other adverse effects : None to our knowledge.
Additional information : Avoid release to the environment

SECTION 13: DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods
Regional legislation (waste) : Dispose of contents/container in accordance with licensed collector’s sorting instructions.
Used device to be handled as infectious.
Additional information : The given EWC-code is a guiding, and the code depends on how the waste is formed. User
must evaluate the choice of correct code.
Ecology - waste materials : Avoid release to the environment.
European List of Waste (LoW) code : 18 01 03* - wastes whose collection and disposal is subject to special requirements in order
to prevent infection

SECTION 14: TRANSPORT INFORMATION

In accordance with ADR / RID / IMDG / IATA / ADN

ADR IMDG IATA RID

14.1. UN number
Not regulated for transport
14.2. UN proper shipping name
Not applicable Not applicable Not applicable Not applicable
14.3. Transport hazard class(es)
Not applicable Not applicable Not applicable Not applicable
Not applicable Not applicable Not applicable Not applicable
14.4. Packing group
Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards

Dangerous for the Dangerous for the Dangerous for the environment : No Dangerous for the
environment : No environment : No environment : No
Marine pollutant : No
No supplementary information available

14.6. Special precautions for user

Special transport precautions : No particular precautions

- Overland transport
No data available

- Transport by sea
No data available

- Air transport
No data available

Rail transport
No data available
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable

SECTION 15: REGULATORY INFORMATION

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU-Regulations

Contains no REACH substances with Annex XVII restrictions

Contains no substance on the REACH candidate list
Contains no REACH Annex XIV substances

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 according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2015/830
301414 Alere Afinion™ CRP 15/02/2016
National regulations
EC-regulation2015/830 /EC, 1907/2006/EC (REACH), 1272/2008/EC (CLP), 790/2009/EC. Transport of dangerous goods (ADR/RID, IMDG,
IATA/ICAO). Workplace exposure limits

15.2. Chemical safety assessment

No chemical safety assessment has been carried out

SECTION 16: OTHER INFORMATION

Indication of changes:
Unknown.
Data sources : EC-regulation2015/830 /EC, 1907/2006/EC (REACH), 1272/2008/EC (CLP), 790/2009/EC.
Transport of dangerous goods (ADR/RID, IMDG, IATA/ICAO). Workplace exposure limits.
Other information : None.
Date of issue : 30/11/2014
Revision date : 15/02/2016
Supersedes : 30/11/2014
Version : 2.0
Signature : K. Dyreskog
Full text of H- and EUH-statements:
Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4
STOT SE 3 Specific target organ toxicity — Single exposure, Category 3, Respiratory tract irritation
H302 Harmful if swallowed
H335 May cause respiratory irritation
EUH210 Safety data sheet available on request

The information in this safety data sheet is based on information from the manufacturer/supplier, present European and national legislation, and presupposes that the product is used within the
specified area of application.

Essenticon - SDS EU v2 EN (English) 6/6