SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name : Activator
Product code : 04663632190
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)
Not a hazardous substance or mixture.
2.3 Other hazards
See SECTION 3
SECTION 3: Composition/information on ingredients
Activator
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
Classification (REGULATION (EC) No 1272/2008)
Not a hazardous substance or mixture.
Chemical nature : Handle as potentially infectious.
Components
Remarks : No hazardous ingredients
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
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.
5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : No information available.
fighting
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
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 : Avoid dust formation.
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 : Pick up and arrange disposal without creating dust.
Sweep up and shovel.
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 : Provide appropriate exhaust ventilation at places where dust
fire and explosion is formed.
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.
Advice on common storage : No materials to be especially mentioned.
Storage class (TRGS 510) : 13, Non Combustible Solids
Further information on stor- : No decomposition if stored and applied as directed.
age stability
7.3 Specific end use(s)
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
Specific use(s) : Laboratory chemicals
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Activator
Contains no substances with occupational exposure limit values.
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.
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Activator
Physical state : solid
Colour : No data available
Odour : Not applicable
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 : Not applicable
Viscosity
Viscosity, dynamic : Not applicable
Viscosity, kinematic : Not applicable
Solubility(ies)
Water solubility : 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
5 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
9.2 Other information
Activator
Explosives : Not explosive
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
Miscibility with water : No data available
SECTION 10: Stability and reactivity
10.1 Reactivity
10.2 Chemical stability
10.3 Possibility of hazardous reactions
Hazardous reactions : Stable under recommended storage conditions.
No hazards to be specially mentioned.
10.4 Conditions to avoid
No data available
10.5 Incompatible materials
No data available
10.6 Hazardous decomposition products
No data available
SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Activator
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.
6 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
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.
11.2 Information on other hazards
Activator
Endocrine disrupting properties
No data available
SECTION 12: Ecological information
12.1 Toxicity
Activator
No data available
12.2 Persistence and degradability
Activator
No data available
12.3 Bioaccumulative potential
Activator
No data available
12.4 Mobility in soil
Activator
No data available
12.5 Results of PBT and vPvB assessment
Activator
Not relevant
12.6 Endocrine disrupting properties
Activator
No data available
7 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
12.7 Other adverse effects
Activator
No data available
SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product : Special treatment as infectious material is mandatory in com-
pliance with local regulations (disinfection and incineration).
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.
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
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 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
8 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
Water contaminating class : nwg not water endangering
(Germany)
Activator
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
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
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 : 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
9 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
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; 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-
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
10 / 11
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Activator
Version Revision Date: Date of last issue: 05.08.2021
1.17 14.08.2021 Date of first issue: 14.05.2013
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