SAFETY DATA SHEET

according to Regulation (EC) No. 1907/2006

ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

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

1.1 Product identifier

Trade name : ALTL

Product code : 20764957322

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 Limited
Charles Avenue
Burgess Hill
RH15 9RY West Sussex
United Kingdom

Telephone : +44 1444 256000

Telefax : +44 1444 256239
Responsible Department : +44 808 100 1920, +44 808 100 8010-
E-mail address : -
1.4 Emergency telephone number
In case of emergencies: : Health, Safety & Environ- +44 1444 256500 or +44 7802
(Roche Diagnostics Ltd.) ment - 260498
Product Safety / Vigilance +44 1444 256561 or +44 7710
- 391653
Toxicology 24Hr help-line: : NPIS: +44 844 892 0111
Health Advice 24Hr help-line: NHS Direct: +44 845 4647
NHS 24: +44 8454 242424

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)

Not a hazardous substance or mixture.

2.3 Other hazards

See SECTION 3

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

SECTION 3: Composition/information on ingredients

R1 (A / B)
Classification (REGULATION (EC) No 1272/2008)
Not a hazardous substance or mixture.

Components
Remarks : No hazardous ingredients

For explanation of abbreviations see section 16.

R2 (B /C)/R3(C)
Classification (REGULATION (EC) No 1272/2008)
Not a hazardous substance or mixture.

Components
Remarks : No hazardous ingredients

For explanation of abbreviations see section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures

General advice : 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.
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
Symptoms : No information available.

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

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.

5.2 Special hazards arising from the substance or mixture

Specific hazards during fire- : No information available.
fighting

5.3 Advice for firefighters

Special protective equipment : Wear self-contained breathing apparatus for firefighting if nec-
for firefighters essary.

Further information : Standard procedure for chemical fires.

Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Personal precautions : Refer to protective measures listed in sections 7 and 8.

6.2 Environmental precautions

Environmental precautions : Local authorities should be advised if significant spillages
cannot be contained.

6.3 Methods and material for containment and cleaning up

Methods for cleaning up : Wipe up with absorbent material (e.g. cloth, fleece).
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 : For personal protection see section 8.
Smoking, eating and drinking should be prohibited in the ap-
plication area.

Advice on protection against : Normal measures for preventive fire protection.

fire and explosion

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Hygiene measures : Handle in accordance with good industrial hygiene and safety
practice.

7.2 Conditions for safe storage, including any incompatibilities

Requirements for storage : Electrical installations / working materials must comply with
areas and containers the technological safety standards.

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

age conditions

Advice on common storage : No materials to be especially mentioned.

Storage class (TRGS 510) : 12, Non Combustible Liquids

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

R1 (A / B)
Occupational Exposure Limits
Components CAS-No. Value type (Form Control parameters Basis
of exposure)
sodium azide 26628-22-8 TWA 0,1 mg/m3 2000/39/EC
Further information: Identifies the possibility of significant uptake through the
skin, Indicative
STEL 0,3 mg/m3 2000/39/EC
Further information: Identifies the possibility of significant uptake through the
skin, Indicative
AGW 0,2 mg/m3 DE TRGS
900
Peak-limit: excursion factor (category): 2;(I)
Dehydrogenase, d- 9028-36-8 IOEL 0,00006 mg/m3 Roche Indus-
lactate trial Hygiene
Committee
(RIHC)

R2 (B /C)/R3(C)
Occupational Exposure Limits
Components CAS-No. Value type (Form Control parameters Basis
of exposure)
sodium azide 26628-22-8 TWA 0,1 mg/m3 2000/39/EC
Further information: Identifies the possibility of significant uptake through the

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

skin, Indicative
STEL 0,3 mg/m3 2000/39/EC
Further information: Identifies the possibility of significant uptake through the
skin, Indicative
AGW 0,2 mg/m3 DE TRGS
900
Peak-limit: excursion factor (category): 2;(I)
8.2 Exposure controls

Engineering measures
No data available
Personal protective equipment
Eye protection : Safety glasses

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 : Protective suit

Respiratory protection : No personal respiratory protective equipment normally re-

quired.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

R1 (A / B)
Appearance : liquid

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Colour : No data available

Odour : none

Odour Threshold : No data available

pH : 7,4 - 7,8

Melting point/range : No data available

Boiling point/boiling range : No data available

Flash point : does not flash

Evaporation rate : No data available

Flammability (solid, gas) : The product is not flammable., Does not sustain combustion.

Upper explosion limit / Upper : No data available

flammability limit

Lower explosion limit / Lower : No data available

flammability limit

Vapour pressure : No data available

Relative vapour density : No data available

Relative density : No data available

Solubility(ies)
Water solubility : No data available

Solubility in other solvents : No data available

Partition coefficient: n- : No data available

octanol/water

Auto-ignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Explosive properties : Not explosive

Oxidizing properties : The substance or mixture is not classified as oxidizing.

R2 (B /C)/R3(C)
Appearance : liquid

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Colour : No data available

Odour : No data available

Odour Threshold : No data available

pH : 10,0 - 10,4 (25 °C)

Melting point/range : No data available

Boiling point/boiling range : No data available

Flash point : does not flash

Evaporation rate : No data available

Flammability (solid, gas) : The product is not flammable., Does not sustain combustion.

Upper explosion limit / Upper : No data available

flammability limit

Lower explosion limit / Lower : No data available

flammability limit

Vapour pressure : No data available

Relative vapour density : No data available

Relative density : No data available

Solubility(ies)
Water solubility : completely miscible

Solubility in other solvents : No data available

Partition coefficient: n- : No data available

octanol/water

Auto-ignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Explosive properties : Not explosive

Oxidizing properties : The substance or mixture is not classified as oxidizing.

9.2 Other information

R1 (A / B)

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Flammability (liquids) : Does not sustain combustion.

Self-ignition : No data available

R2 (B /C)/R3(C)
Flammability (liquids) : Does not sustain combustion.

Self-ignition : 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 : Stable under recommended storage conditions.
No hazards to be specially mentioned.
10.4 Conditions to avoid
Conditions to avoid : No data available

10.5 Incompatible materials

Materials to avoid : No data available

10.6 Hazardous decomposition products

No data available

SECTION 11: Toxicological information

11.1 Information on toxicological effects

R1 (A / B)
Acute toxicity
Not classified based on available information.
Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Respiratory or skin sensitisation

Skin sensitisation
Not classified based on available information.

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Respiratory sensitisation
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Aspiration toxicity
Not classified based on available information.
R2 (B /C)/R3(C)
Acute toxicity
Not classified based on available information.
Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Respiratory or skin sensitisation

Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Aspiration toxicity
Not classified based on available information.

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

SECTION 12: Ecological information

12.1 Toxicity
R1 (A / B)
No data available
R2 (B /C)/R3(C)
No data available
12.2 Persistence and degradability
R1 (A / B)
No data available
R2 (B /C)/R3(C)
No data available
12.3 Bioaccumulative potential
R1 (A / B)
No data available
R2 (B /C)/R3(C)
No data available
12.4 Mobility in soil
R1 (A / B)
No data available
R2 (B /C)/R3(C)
No data available
12.5 Results of PBT and vPvB assessment
R1 (A / B)
Not relevant
R2 (B /C)/R3(C)
Not relevant
12.6 Other adverse effects
R1 (A / B)
No data available
R2 (B /C)/R3(C)
No data available

SECTION 13: Disposal considerations

13.1 Waste treatment methods

Product : Can be disposed as waste water, when in compliance with
local regulations.

Contaminated packaging : Empty containers should be taken to an approved waste han-

dling site for recycling or disposal.

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Do not re-use empty containers.

SECTION 14: Transport information

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

14.7 Transport in bulk according to Annex II of Marpol and the IBC Code
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 1 slightly hazardous to water

(Germany)

R1 (A / B)
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

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

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

The components of this product are reported in the following inventories:

DSL : All components of this product are on the Canadian DSL

AICS : Not in compliance with the inventory

NZIoC : On the inventory, or 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 : On the inventory, or 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

Labelling (REGULATION (EC) No 1272/2008)

Not a hazardous substance or mixture.

R2 (B /C)/R3(C)
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

12 / 14
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

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

The components of this product are reported in the following inventories:

DSL : All components of this product are on the Canadian DSL

AICS : On the inventory, or in compliance with the inventory

NZIoC : On the inventory, or 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 : On the inventory, or 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)
Volatile organic compounds (VOC) content: 0,16 %

Labelling (REGULATION (EC) No 1272/2008)

Not a hazardous substance or mixture.

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 other abbreviations

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; AICS - Australian Inventory of Chemical Substances; ASTM - American Society
for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regula-
tion; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN
- Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Cana-
da); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx -
Concentration associated with x% response; ELx - Loading rate associated with x% response;
EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx -

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
ALTL
Version Revision Date: Date of last issue: 31.07.2020
1.16 31.12.2020 Date of first issue: 28.09.2012

Concentration associated with x% growth rate response; GHS - Globally Harmonized System;
GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - In-
ternational Air Transport Association; IBC - International Code for the Construction and Equip-
ment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentra-
tion; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical
Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Mari-
time Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisa-
tion for Standardization; 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 Specified; 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 Develop-
ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu-
lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc-
es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua-
tion, Authorisation and Restriction 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 Sub-
stances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very Bioac-
cumulative

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 / 2004

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