Safety Data Sheet

according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 1 of 21 pages Version: 1.3

Name of the mixture: CREATININE

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

company/undertaking
1.1 Product identifier
CREATININE
Pack Name CREA 500 S CREA 500 CREA 275 CREA 564 XL-1000
Cat. No. BLT00021 BLT00022 XSYS0024 XSYS0076
Reagent 1 4×100 ml 4×100 ml 5×44 ml 6×72 ml
1.2 Relevant identified uses of the substance or mixture and uses advised against
The sets are designed for Health Service laboratories for determination of creatinine concentration in
serum and plasma. The mixture is intended for professional use.
1.3 Details of the supplier of the safety data sheet
Name of manufacturer: Erba Lachema s.r.o.
Place of business: Brno, Karásek 1d, postcode 621 00, CZ
ID no: 26918846
Phone: +420 517 077 111
E-mail: msds@erbalachema.com
1.4 Emergency telephone number
Erba Lachema s.r.o.
Phone: +420 517 077 556 (service only during business hours)
Toxicological Information Centre (TIS), Na Bojišti 1, 128 01 Prague 2
Phone: +420 224 919 293 or +420 224 915 402 (service available 24 hours a day)
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008
Skin Irrit. 2 H315
Eye Irrit. 2 H319
Classification according to 67/548/EEC or 1999/45/EC
Xi R36/38
For a full text of R-phrases and H-statements see Section 16.
2.2 Label elements

Pictogram:
Signal word: Warning
Hazard-determining components of labelling:
Sodium hydroxide
Hazard statement(s):
H315 Causes skin irritation.
H319 Causes serious eye irritation.
Precautionary statement(s):
P280 Wear protective gloves/protective clothing/eye protection.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 2 of 21 pages Version: 1.3

Name of the mixture: CREATININE

P302+P352 IF ON SKIN: Wash with plenty of water.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
2.3 Other hazards
Reagent 1 is not classified as PBT or vPvB.
SECTION 3: Composition/information on ingredients
3.1 Substances
The product is a mixture.
3.2 Mixtures
Reagent 1 contains following hazardous substances:
CAS number Classification according to
Content
Substance name EC number
(% of weight) 67/548/EEC 1272/2008
Index number
Sodium 1.0 1310-73-2 C; R35 Skin Corr. 1A H314
hydroxide* 215-185-5
011-002-00-6
*) Substance with exposure limits (exposure limits are listed in Section 8.1)
For a full text of R-phrases and H-statements see Section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures
When working with the mixture, take care of personal hygiene and prevent contamination of work
clothing and skin. If you have any doubts or when symptoms persist, seek medical attention.
Exposure by inhalation
Discontinue the exposure, remove casualty to fresh air, keep at rest and seek medical advice.
Exposure by contact with skin
After contact with skin, wash immediately with soap and water.
Exposure by contact with eyes
Rinse an open eye (hold eyelids with fingers) with plenty of water for about 15 minutes, transfer casualty
to a specialist.
Exposure by ingestion
Rinse mouth with water, drink 1/2 l of lukewarm water, seek medical attention immediately, and do not
induce vomiting.
4.2 Most important symptoms and effects, both acute and delayed
No data available.
4.3 Indication of any immediate medical attention and special treatment needed
No data available.
SECTION 5: Firefighting measures
The mixture is not flammable. The measure should be adapted to burning substances in the surrounding
area.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 3 of 21 pages Version: 1.3

Name of the mixture: CREATININE

5.1 Extinguishing media

Water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
5.2 Special hazards arising from the substance or mixture
Not known.
5.3 Advice for firefighters
Use breathing apparatus. Wear protective clothing.
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment, see Section 8. Observe the principles of work safety in chemical
laboratories. Do not eat, drink or smoke.
6.2 Environmental precautions
No special precautions required.
6.3 Methods and material for containment and cleaning up
Absorb spilled agent with a suitable inert material (sand, earth, vapex) and store contaminated material in
containers for collection of hazardous waste. For waste disposal, see Section 13. Sweep solid reagent and
store in containers for collection of hazardous waste. For waste disposal, see Section 13.
6.4 Reference to other sections
See section 7, 8 and 13.
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Observe the principles of work in laboratory. Observe the normal operating procedures for handling
chemical substances and mixtures. Do not eat, drink or smoke. Use personal protective equipment, see
Section 8.
7.2 Conditions for safe storage, including any incompatibilities
Store in dry and covered stores in tightly closed containers at a temperature between +2 °C and +8 °C.
7.3 Specific end use(s)
The kit is designed for in vitro diagnostic devices.
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Control parameters of the mixture components according to Government Decree No 361/2007 Coll.
CAS Substance name PEL NPK-P Note Conversion
mg/m3 mg/m3 factor for
ppm
1310-73-2 Sodium hydroxide 1 2 I –
PEL - Permissible exposure limits; NPK-P - the maximum permissible concentration; D - a significant penetration of the substance through the
skin or a strong irritating effect on the skin during exposure; S - the substance has a sensitizing effect; P - serious late effects of the substance
cannot be excluded; I – causes irritation of mucous membranes (eyes, respiratory system), resp. skin. * - the physico-chemical properties (e.g.
explosiveness) are taken into account for NPK-P.

Exposure limit values in the workplace are not defined according to Directive No 2006/15/EC.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 4 of 21 pages Version: 1.3

Name of the mixture: CREATININE

Limit values for indicators of biological exposure tests are not defined according to Decree No
432/2003 Coll.
8.2 Exposure controls
Appropriate engineering controls
Sufficient ventilation.
Personal protective equipment
a. Eye/face protection
Safety goggles.
b. Hand protection
Protective gloves - rubber, resistant to caustic substances.
c. Skin protection
Protective clothing.
d. Respiratory protection
Not required.
e. Thermal hazards
None known.
Environmental exposure controls
To eliminate the emergency conditions, have pre-prepared a decontamination mixture and appropriate
collection vessels for reaction residues. Dispose of reaction residues and decontaminated mixtures as
hazardous waste water in accordance with relevant legal regulations.
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
a. Appearance ................................................. ................................... Clear colourless liquid
b. Odour .......................................................... ................................... Information not available
c. Odour threshold .......................................... ................................... Information not available
d. pH (at 20 °C) .............................................. ................................... >12.5
e. Melting point/freezing point ....................... ................................... Information not available
f. Initial boiling point and boiling range (°C) ................................... Information not available
g. Flash point (°C) .......................................... ................................... Information not available
h. Evaporation rate .......................................... ................................... Information not available
i. Flammability (solid, gas) ............................ ................................... Information not available
j. Upper/lower flammability or explosive limits ................................ Information not available
k. Vapour pressure (hPa) ................................ ................................... Information not available
l. Vapour density............................................ ................................... Information not available
m. Relative density (kg m−3) ............................ ................................... 1 010 at 25 °C
n. Water solubility .......................................... ................................... Information not available
o. Partition coefficient: n-octanol/water ......... ................................... Information not available
p. Autoignition temperature (°C) .................... ................................... Information not available
q. Decomposition temperature (°C) ................ ................................... Information not available
r. Viscosity ..................................................... ................................... Information not available
s. Explosive properties ................................... ................................... Information not available
t. Oxidizing properties ................................... ................................... Information not available
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 5 of 21 pages Version: 1.3

Name of the mixture: CREATININE

9.2 Other information

None.
SECTION 10: Stability and reactivity
Under normal conditions of use and storage the mixture is stable.
10.1 Reactivity
No data available.
10.2 Chemical stability
The mixture is stable at normal temperature and pressure.
10.3 Possibility of hazardous reactions
No data available.
10.4 Conditions to avoid
No data available.
10.5 Incompatible materials
Organic materials, strong oxidizing agents and strong acids.
10.6 Hazardous decomposition products
Not known.
SECTION 11: Toxicological information
11.1 Information on toxicological effects
a) Acute toxicity
Based on available data, the classification criteria are not met.
b) Irritability
Reagent 1 is classified as irritating to skin. It causes serious eye irritation.
c) Corrosion
Based on available data, the classification criteria are not met.
d) Sensitization
Based on available data, the classification criteria are not met.
e) Repeated dose toxicity
Based on available data, the classification criteria are not met.
f) Carcinogenicity
Based on available data, the classification criteria are not met.
g) Mutagenicity
Based on available data, the classification criteria are not met.
h) Reproductive toxicity
Based on available data, the classification criteria are not met.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 6 of 21 pages Version: 1.3

Name of the mixture: CREATININE

SECTION 12: Ecological information

12.1 Toxicity
No data available.
12.2 Persistence and degradability
No data available.
12.3 Bioaccumulative potential
No data available.
12.4 Mobility in soil
No data available.
12.5 Results of PBT and vPvB assessment
The product does not have the properties of PBT and vPvB. Assessment based on the ingredients that do
not have properties of PBT and vPvB.
12.6 Other adverse effects
There is no information about any special danger for environment.
SECTION 13: Disposal considerations
13.1 Waste treatment methods
Dispose of in compliance with applicable regulations for hazardous waste management. Do not drain into
the wastewater. The mixture should be discarded as a laboratory waste. Incinerate residues of the mixture
in a hazardous waste incinerator. Contaminated packaging must be treated as hazardous waste.
Waste code 15 01 10 packaging containing residues of or contaminated by dangerous substances
16 05 06 laboratory chemicals, consisting of or containing dangerous substances,
including mixtures of laboratory chemicals
SECTION 14: Transport information
Not governed by regulations for transport of dangerous goods (ADR).
14.1 UN number
Not specified.
14.2 UN proper shipping name
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.3 Transport hazard class(es)
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.4 Packing group
ADR/RID: –
IMDG: –
ICAO/IATA: –
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 7 of 21 pages Version: 1.3

Name of the mixture: CREATININE

14.5 Environmental hazards

The mixture is not hazardous to the environment during transport.
14.6 Special precautions for user
No data available.
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not transported.
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixture
This safety data sheet complies with the requirements of Regulation (EC) No 1907/2006 (REACH) and
Regulation (EC) No 1272/2008 (CLP).
15.2 Chemical safety assessment
Assessment was not carried out.
SECTION 16: Other information
List of H and R-phrases
H-statements: H314 Causes severe skin burns and eye damage.
H315 Causes skin irritation.
H319 Causes serious eye irritation.

R-phrases: R35 Causes severe burns.

R36/38 Irritating to eyes and skin.
Recommended restrictions on use
This compound is designed for professional use. It should not be used for purposes other than those
described in Section 1.2.
Information about data sources used to compile the Safety Data Sheet
Material Safety Data Sheets of raw material suppliers, ECHA (European Chemicals Agency), corporate
documentation for products

Declaration
The safety data sheet contains basic data corresponding to the present state of our knowledge and
experience, in accordance with applicable regulations. The foregoing information was gathered with the
utmost care, but that does not mean that it is complete and should be used as the only correct information.
Erba Lachema s.r.o. is not responsible for any damages caused by improper use and handling of the
mixture
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 8 of 21 pages Version: 1.3

Name of the mixture: CREATININE

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

company/undertaking
1.1 Product identifier
CREATININE
Pack Name CREA 500 S CREA 500 CREA 275 CREA 564 XL-1000
Cat. No. BLT00021 BLT00022 XSYS0024 XSYS0076
Reagent 2 1×100 ml 1×100 ml 5×11 ml 6×22 ml

1.2 Relevant identified uses of the substance or mixture and uses advised against
The sets are designed for Health Service laboratories for determination of creatinine concentration in
serum and plasma. The mixture is intended for professional use.
1.3 Details of the supplier of the safety data sheet
Name of manufacturer: Erba Lachema s.r.o.
Place of business: Brno, Karásek 1d, postcode 621 00, CZ
ID no: 26918846
Phone: +420 517 077 111
E-mail: msds@erbalachema.com
1.4 Emergency telephone number
Erba Lachema s.r.o.
Phone: +420 517 077 556 (service only during business hours)
Toxicological Information Centre (TIS), Na Bojišti 1, 128 01 Prague 2
Phone: +420 224 919 293 or +420 224 915 402 (service available 24 hours a day)
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008
Reagent 2 is not classified as hazardous. However, it contains a low concentration of toxic picric acid and
caustic sodium hydroxide with exposure limit.
Classification according to 67/548/EEC or 1999/45/EC
Reagent 2 is not classified as dangerous. However, it contains a low concentration of toxic picric acid and
caustic sodium hydroxide with exposure limit.
2.2 Label elements
The product does not need to be labelled in accordance with EC directives.
2.3 Other hazards
Reagent 2 is not classified as PBT or vPvB.
Explosive when dry.
SECTION 3: Composition/information on ingredients
3.1 Substances
The product is a mixture.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 9 of 21 pages Version: 1.3

Name of the mixture: CREATININE

3.2 Mixtures
Reagent 2 contains following hazardous substances:
CAS number Classification according to
Content
Substance name EC number
(% of weight) 67/548/EEC 1272/2008
Index number
Picric acid* <1.0 88-89-1 E; R3 Expl. 1.1 H201
201-865-9 R4 Acute Tox. 3 H301
609-009-00-X T; R23/24/25 Acute Tox. 3 H311
Acute Tox. 3 H331
*) Substance with exposure limits (exposure limits are listed in Section 8.1)
For a full text of R-phrases and H-statements see Section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures
When working with the mixture, take care of personal hygiene and prevent contamination of work
clothing and skin. If you have any doubts or when symptoms persist, seek medical attention.
Exposure by inhalation
Discontinue the exposure, remove casualty to fresh air, keep at rest and seek medical advice.
Exposure by contact with skin
Take off all contaminated clothing. After contact with skin, wash immediately with soap and water.
Exposure by contact with eyes
Rinse an open eye (hold eyelids with fingers) with plenty of water for about 15 minutes, transfer casualty
to a specialist.
Exposure by ingestion
Rinse mouth with water, seek medical advice.
4.2 Most important symptoms and effects, both acute and delayed
Discolouration of skin. Dust causes sensitisation dermatitis.
4.3 Indication of any immediate medical attention and special treatment needed
No data available.
SECTION 5: Firefighting measures
The mixture is not flammable. The measure should be adapted to burning substances in the surrounding
area.
5.1 Extinguishing media
Unsuitable extinguishing media:
For mixture no unsuitable extinguishing media are known.
5.2 Special hazards arising from the substance or mixture
Carbon oxides, nitrogen oxides (NOx).
5.3 Advice for firefighters
Use breathing apparatus. Wear protective clothing.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 10 of 21 pages Version: 1.3

Name of the mixture: CREATININE

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment, see Section 8. Observe the principles of work safety in chemical
laboratories. Do not eat, drink or smoke.
6.2 Environmental precautions
Do not discharge into the drains, surface waters and groundwater.
6.3 Methods and material for containment and cleaning up
Absorb spilled agent with a suitable inert material (sand, earth, vapex) and store contaminated material in
containers for collection of hazardous waste. For waste disposal, see Section 13.
6.4 Reference to other sections
See section 7, 8 and 13.
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Observe the principles of work in laboratory. Observe the normal operating procedures for handling
chemical substances and mixtures. Do not eat, drink or smoke. Use personal protective equipment, see
Section 8.
7.2 Conditions for safe storage, including any incompatibilities
Store in dry and covered stores in tightly closed containers at a temperature between +2 °C and +8 °C.
7.3 Specific end use(s)
The kit is designed for in vitro diagnostic devices.
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Control parameters of the mixture components according to Government Decree No 361/2007 Coll.
CAS Substance name PEL NPK-P Note Conversion
mg/m3 mg/m3 factor for
ppm
88-89-1 Picric acid 0.1 0.5 D, I, S –
PEL - Permissible exposure limits; NPK-P - the maximum permissible concentration; D - a significant penetration of the substance through the
skin or a strong irritating effect on the skin during exposure; S - the substance has a sensitizing effect; P - serious late effects of the substance
cannot be excluded; I – causes irritation of mucous membranes (eyes, respiratory system), resp. skin. * - the physico-chemical properties (e.g.
explosiveness) are taken into account for NPK-P.
Exposure limit values in the workplace according to Directive No 2006/15/EC.
CAS Substance name Limit values Note
8 hrs Short term
mg/m3 ppm mg/m3 ppm
88-89-1 Picric acid 0.1 – – – –
The note “skin” attached to the exposure limit values in the workplace indicates the possibility of a serious penetration through the skin.
Limit values for indicators of biological exposure tests are not defined according to Decree No
432/2003 Coll.
8.2 Exposure controls
Appropriate engineering controls
Sufficient ventilation.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 11 of 21 pages Version: 1.3

Name of the mixture: CREATININE

Personal protective equipment

a. Eye/face protection
Safety goggles.
b. Hand protection
Protective gloves - rubber, resistant to caustic substances.
c. Skin protection
Protective clothing.
d. Respiratory protection
Not required with adequate ventilation.
e. Thermal hazards
None known.
Environmental exposure controls
To eliminate the emergency conditions, have pre-prepared a decontamination mixture and appropriate
collection vessels for reaction residues. Dispose of reaction residues and decontaminated mixtures as
hazardous waste water in accordance with relevant legal regulations.
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
a. Appearance ................................................. ................................... Clear yellow liquid
b. Odour .......................................................... ................................... Information not available
c. Odour threshold .......................................... ................................... Information not available
d. pH (at 20 °C) .............................................. ................................... <4.5
e. Melting point/freezing point ....................... ................................... Information not available
f. Initial boiling point and boiling range (°C) ................................... Information not available
g. Flash point (°C) .......................................... ................................... Information not available
h. Evaporation rate .......................................... ................................... Information not available
i. Flammability (solid, gas) ............................ ................................... Information not available
j. Upper/lower flammability or explosive limits ................................ Information not available
k. Vapour pressure (hPa) ................................ ................................... Information not available
l. Vapour density............................................ ................................... Information not available
m. Relative density (kg m−3) ............................ ................................... 1 005
n. Water solubility .......................................... ................................... Information not available
o. Partition coefficient: n-octanol/water ......... ................................... Information not available
p. Autoignition temperature (°C) .................... ................................... Information not available
q. Decomposition temperature (°C) ................ ................................... Information not available
r. Viscosity ..................................................... ................................... Information not available
s. Explosive properties ................................... ................................... Information not available
t. Oxidizing properties ................................... ................................... Information not available
9.2 Other information
None.
SECTION 10: Stability and reactivity
Under normal conditions of use and storage the mixture is stable.
10.1 Reactivity
No data available.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 12 of 21 pages Version: 1.3

Name of the mixture: CREATININE

10.2 Chemical stability

The mixture is stable at normal temperature and pressure.
10.3 Possibility of hazardous reactions
Not known.
10.4 Conditions to avoid
Heavy metals, ammonia, amines, aromatic hydrocarbon. Dry mixtures of picric acid and aluminium
powder with water causes ignition.
10.5 Incompatible materials
Strong oxidizing agents.
10.6 Hazardous decomposition products
Not known.
SECTION 11: Toxicological information
11.1 Information on toxicological effects
a) Acute toxicity
Based on available data, the classification criteria are not met.
b) Irritability
Based on available data, the classification criteria are not met.
c) Corrosion
Based on available data, the classification criteria are not met.
d) Sensitization
Based on available data, the classification criteria are not met.
e) Repeated dose toxicity
Based on available data, the classification criteria are not met.
f) Carcinogenicity
Based on available data, the classification criteria are not met.
g) Mutagenicity
Based on available data, the classification criteria are not met.
h) Reproductive toxicity
Based on available data, the classification criteria are not met.
SECTION 12: Ecological information
12.1 Toxicity
No data available.
12.2 Persistence and degradability
No data available.
12.3 Bioaccumulative potential
No data available.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 13 of 21 pages Version: 1.3

Name of the mixture: CREATININE

12.4 Mobility in soil

No data available.
12.5 Results of PBT and vPvB assessment
The product does not have the properties of PBT and vPvB. Assessment based on the ingredients that do
not have properties of PBT and vPvB.
12.6 Other adverse effects
There is no information about any special danger for environment.
SECTION 13: Disposal considerations
13.1 Waste treatment methods
Dispose of in compliance with applicable regulations for hazardous waste management. Do not drain into
the wastewater. The mixture should be discarded as a laboratory waste. Incinerate residues of the mixture
in a hazardous waste incinerator. Contaminated packaging must be treated as hazardous waste.
SECTION 14: Transport information
Not governed by regulations for transport of dangerous goods (ADR).
14.1 UN number
Not specified.
14.2 UN proper shipping name
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.3 Transport hazard class(es)
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.4 Packing group
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.5 Environmental hazards
The mixture is not hazardous to the environment during transport.
14.6 Special precautions for user
No data available.
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not transported.
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixture
This safety data sheet complies with the requirements of Regulation (EC) No 1907/2006 (REACH) and
Regulation (EC) No 1272/2008 (CLP).
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 14 of 21 pages Version: 1.3

Name of the mixture: CREATININE

15.2 Chemical safety assessment

Assessment was not carried out.
SECTION 16: Other information
List of H-statements and R-phrases
H-statements: H201 Explosive; mass explosion hazard.
H301 Toxic if swallowed.
H311 Toxic in contact with skin.
H331 Toxic if inhaled.

R-phrases: R3 Extreme risk of explosion by shock, friction, fire or other sources of ignition.
R4 Forms very sensitive explosive metallic compounds.
R23/24/25 Toxic by inhalation, in contact with skin and if swallowed.

Recommended restrictions on use

This compound is designed for professional use. It should not be used for purposes other than those
described in Section 1.2.
Information about data sources used to compile the Safety Data Sheet
Material Safety Data Sheets of raw material suppliers, ECHA (European Chemicals Agency), corporate
documentation for products.

Declaration
The safety data sheet contains basic data corresponding to the present state of our knowledge and
experience, in accordance with applicable regulations. The foregoing information was gathered with the
utmost care, but that does not mean that it is complete and should be used as the only correct information.
Erba Lachema s.r.o. is not responsible for any damages caused by improper use and handling of the
mixture
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 15 of 21 pages Version: 1.3

Name of the mixture: CREATININE

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

company/undertaking
1.1 Product identifier
CREATININE
Pack Name CREA 500 S CREA 500 CREA 275 CREA 564 XL-1000
Cat. No. BLT00021 BLT00022 XSYS0024 XSYS0076
Reagent 3 STD 1×10 ml 1×10 ml – –

1.2 Relevant identified uses of the substance or mixture and uses advised against
The sets are designed for Health Service laboratories for determination of creatinine concentration in
serum and plasma. The mixture is intended for professional use.
1.3 Details of the supplier of the safety data sheet
Name of manufacturer: Erba Lachema s.r.o.
Place of business: Brno, Karásek 1d, postcode 621 00, CZ
ID no: 26918846
Phone: +420 517 077 111
E-mail: msds@erbalachema.com
1.4 Emergency telephone number
Erba Lachema s.r.o.
Phone: +420 517 077 556 (service only during business hours)
Toxicological Information Centre (TIS), Na Bojišti 1, 128 01 Prague 2
Phone: +420 224 919 293 or +420 224 915 402 (service available 24 hours a day)
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008
Reagent 3 STD is not classified as hazardous.
Classification according to 67/548/EEC or 1999/45/EC
Reagent 3 STD is not classified as dangerous.
2.2 Label elements
The product does not need to be labelled in accordance with EC directives.
2.3 Other hazards
Reagent 3 STD is not classified as PBT or vPvB.
SECTION 3: Composition/information on ingredients
3.1 Substances
The product is a mixture.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 16 of 21 pages Version: 1.3

Name of the mixture: CREATININE

3.2 Mixtures
Reagent 3 STD contains following hazardous substances:
CAS number Classification according to
Content
Substance name EC number
(% of weight) 67/548/EEC 1272/2008
Index number
Benzoic acid <0.2 65-85-0 Xi; R38-41 Skin Irrit. 2 H315
200-618-2 T; R48/23 Eye Dam. 1 H318
607-705-00-8 STOT RE 1 H372
(lungs, inhalation)
For a full text of R-phrases and H-statements see Section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures
No special measures required.
Exposure by inhalation
Discontinue the exposure.
Exposure by contact with skin
After contact with skin, wash with soap and water.
Exposure by contact with eyes
Rinse an open eye (hold eyelids with fingers) with plenty of water for about 15 minutes.
Exposure by ingestion
Rinse mouth with water, drink 1/2 l of lukewarm water.
4.2 Most important symptoms and effects, both acute and delayed
No data available.
4.3 Indication of any immediate medical attention and special treatment needed
No data available.
SECTION 5: Firefighting measures
The mixture is not flammable. The measure should be adapted to burning substances in the surrounding
area.
5.1 Extinguishing media
For mixture no unsuitable extinguishing media are known.
5.2 Special hazards arising from the substance or mixture
None.
5.3 Advice for firefighters
Use breathing apparatus. Wear protective clothing.
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment, see Section 8. Observe the principles of work safety in chemical
laboratories. Do not eat, drink or smoke.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 17 of 21 pages Version: 1.3

Name of the mixture: CREATININE

6.2 Environmental precautions

No special precautions required.
6.3 Methods and material for containment and cleaning up
Absorb spilled agent with a suitable inert material (sand, earth, vapex) and store contaminated material in
containers for collection of hazardous waste. For waste disposal, see Section 13.
6.4 Reference to other sections
See section 7, 8 and 13.
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Observe the principles of work in laboratory. Observe the normal operating procedures for handling
chemical substances and mixtures. Do not eat, drink or smoke. Use personal protective equipment, see
Section 8.
7.2 Conditions for safe storage, including any incompatibilities
Store in dry and covered stores in tightly closed containers at a temperature between +2 °C and +8 °C.
7.3 Specific end use(s)
The kit is designed for in vitro diagnostic devices.
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Control parameters of the mixture components are not defined according to Government Decree
No 361/2007 Coll.
Exposure limit values in the workplace are not defined according to Directive No 2006/15/EC.
Limit values for indicators of biological exposure tests are not defined according to Decree No
432/2003 Coll.
8.2 Exposure controls
Appropriate engineering controls
Sufficient ventilation.
Personal protective equipment
a. Eye/face protection
Safety goggles.
b. Hand protection
Protective gloves - rubber, resistant to caustic substances.
c. Skin protection
Protective clothing.
d. Respiratory protection
Not required with adequate ventilation.
e. Thermal hazards
None known.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 18 of 21 pages Version: 1.3

Name of the mixture: CREATININE

Environmental exposure controls

To eliminate the emergency conditions, have pre-prepared a decontamination mixture and appropriate
collection vessels for reaction residues. Dispose of reaction residues and decontaminated mixtures as
hazardous waste water in accordance with relevant legal regulations.
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
a. Appearance ................................................. ................................... Clear colourless liquid
b. Odour .......................................................... ................................... Odourless
c. Odour threshold .......................................... ................................... Information not available
d. pH (at 20 °C) .............................................. ................................... Information not available
e. Melting point/freezing point (°C) ............... ................................... ≈ 0
f. Initial boiling point and boiling range (°C) ................................... ≈ 100
g. Flash point (°C) .......................................... ................................... Information not available
h. Evaporation rate .......................................... ................................... Information not available
i. Flammability (solid, gas) ............................ ................................... Information not available
j. Upper/lower flammability or explosive limits ................................ Information not available
k. Vapour pressure (hPa) ................................ ................................... Information not available
l. Vapour density............................................ ................................... Information not available
m. Relative density (kg m−3) ............................ ................................... Information not available
n. Water solubility .......................................... ................................... Infinite
o. Partition coefficient: n-octanol/water ......... ................................... Information not available
p. Autoignition temperature (°C) .................... ................................... Information not available
q. Decomposition temperature (°C) ................ ................................... Information not available
r. Viscosity ..................................................... ................................... Information not available
s. Explosive properties ................................... ................................... Information not available
t. Oxidizing properties ................................... ................................... Information not available
9.2 Other information
None.
SECTION 10: Stability and reactivity
Under normal conditions of use and storage the mixture is stable.
10.1 Reactivity
No data available.
10.2 Chemical stability
The mixture is stable at normal temperature and pressure.
10.3 Possibility of hazardous reactions
Not known.
10.4 Conditions to avoid
Avoid exposure to heat of solar radiation.
10.5 Incompatible materials
None.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 19 of 21 pages Version: 1.3

Name of the mixture: CREATININE

10.6 Hazardous decomposition products

Oxides and carbon when heated to decomposition.
SECTION 11: Toxicological information
11.1 Information on toxicological effects
a) Acute toxicity
Based on available data, the classification criteria are not met.
b) Irritability
Based on available data, the classification criteria are not met.
c) Corrosion
Based on available data, the classification criteria are not met.
d) Sensitization
Based on available data, the classification criteria are not met.
e) Repeated dose toxicity
Based on available data, the classification criteria are not met.
f) Carcinogenicity
Based on available data, the classification criteria are not met.
g) Mutagenicity
Based on available data, the classification criteria are not met.
h) Reproductive toxicity
Based on available data, the classification criteria are not met.
SECTION 12: Ecological information
12.1 Toxicity
No data available.
12.2 Persistence and degradability
No data available.
12.3 Bioaccumulative potential
No data available.
12.4 Mobility in soil
No data available.
12.5 Results of PBT and vPvB assessment
The product does not have the properties of PBT and vPvB. Assessment based on the ingredients that do
not have properties of PBT and vPvB.
12.6 Other adverse effects
There is no information about any special danger for environment.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 20 of 21 pages Version: 1.3

Name of the mixture: CREATININE

SECTION 13: Disposal considerations

13.1 Waste treatment methods
Dispose of in compliance with applicable regulations for hazardous waste management. Do not drain into
the wastewater. The mixture should be discarded as a laboratory waste. Incinerate residues of the mixture
in a hazardous waste incinerator. Contaminated packaging must be treated as hazardous waste.
SECTION 14: Transport information
Not governed by regulations for transport of dangerous goods (ADR).
14.1 UN number
Not specified.
14.2 UN proper shipping name
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.3 Transport hazard class(es)
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.4 Packing group
ADR/RID: –
IMDG: –
ICAO/IATA: –
14.5 Environmental hazards
The mixture is not hazardous to the environment during transport.
14.6 Special precautions for user
No data available.
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not transported.
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixture
This safety data sheet complies with the requirements of Regulation (EC) No 1907/2006 (REACH) and
Regulation (EC) No 1272/2008 (CLP).
15.2 Chemical safety assessment
Assessment was not carried out.
SECTION 16: Other information
List of H-statements and R-phrases
H-statements: H315 Causes skin irritation.
H318 Causes serious eye damage.
H372 Causes damage to organs through prolonged or repeated exposure.
 Safety Data Sheet
according to the European Parliament and Council Regulation (EC) No 1907/2006 (REACH), Article 31, Annex II

Date of issue: 23.03.2015 Date of review: 04.05.2015 Page 21 of 21 pages Version: 1.3

Name of the mixture: CREATININE

R-phrases: R38 Irritating to skin.

R41 Risk of serious damage to eyes.
R48/23 Toxic: danger of serious damage to health by prolonged exposure through
inhalation.
Recommended restrictions on use
This compound is designed for professional use. It should not be used for purposes other than those
described in Section 1.2.
Information about data sources used to compile the Safety Data Sheet
Material Safety Data Sheets of raw material suppliers, ECHA (European Chemicals Agency), corporate
documentation for products

Declaration
The safety data sheet contains basic data corresponding to the present state of our knowledge and
experience, in accordance with applicable regulations. The foregoing information was gathered with the
utmost care, but that does not mean that it is complete and should be used as the only correct information.
Erba Lachema s.r.o. is not responsible for any damages caused by improper use and handling of the
mixture