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EC number: 200-306-6 | CAS number: 57-00-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-9-22 to 1997-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guideline for LLNA was not available when the test was conducted.
Test material
- Reference substance name:
- N-(aminoiminomethyl)-N-methyl-Glycine, monohydrate
- Cas Number:
- 6020-87-7
- Molecular formula:
- C4H9N3O2*H2O
- IUPAC Name:
- N-(aminoiminomethyl)-N-methyl-Glycine, monohydrate
- Details on test material:
- - Name of test material (as cited in study report): Creatine monohydrate
- Substance type: organic
- Physical state: slightly yellow solid
- Analytical purity: 101.1%
- Purity test date: 1997-11-26
- Lot/batch No.:725 201
- Expiration date of the lot/batch: 1998-9-15
- Stability under test conditions: at least 96 h
- Storage condition of test material: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd. Basel, Switzerland
- Age at study initiation: approx. 7 weeks old
- Weight at study initiation: group mean did not exceed 500 g
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- (1 % aqueous carboxymethyl cellulose)
- Concentration / amount:
- Test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (1% Aqueous Carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.
Induction: intradermal injection 2 % (w/w); epidermal treatment with 50% (w/w)
Challenge: epidermal application of 50% test substance (0.5 ml)
Challengeopen allclose all
- Route:
- other: epidermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- (1 % aqueous carboxymethyl cellulose)
- Concentration / amount:
- Test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (1% Aqueous Carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.
Induction: intradermal injection 2 % (w/w); epidermal treatment with 50% (w/w)
Challenge: epidermal application of 50% test substance (0.5 ml)
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: selection of test substance concentrations suitable for induction and challenge;
Test concentrations: undiluted, 50%, 20%, 10%, 5%, 2%, 1%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: day 1 to 8
- Test groups: 1 group consisting of 10 animals
- Control group: consisting of 5 animals; was treated as described for experimental animal, except that, instead of the test substance, the vehicle was administered
- Site: scapular region
- Duration: 8 days
- Concentrations: 2% and 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 (on day day 21)
- Exposure period: 24 h
- Test groups: all animals
- Control group: consisting of 5 animals; was treated as described for experimental animals, except that, instead of the test substance, the vehicle was administered
- Site: scapular region
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- negative/vehicle control: instead of the test substance , the vehicle was administered
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde, tech. 85%
Results and discussion
- Positive control results:
- The sensitivity of female albino Himalayan guinea pigs to alpha-hexylcinnamicaldehyde, tech. 85% was checked. The experiments led to determination of a sensitisation rate of 100% to both the 10% and 5% concentrations of the substance.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- score 2 and 3
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- score 2 and 3
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- score 2 and 3
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- score 1, 2 and 3
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study creatine monohydrate is not skin sensitizing
- Executive summary:
In a dermal sensitization study based on OECD guideline No. 406 "Skin Sensitization (maximization test) creatine monohydrate in 1 % aqueous carboxymethyl cellulose was tested in female albino guinea pigs (Himalayan strain; approx. 7 weeks old; body weight mean < 500 g). A reliability check was carried out with alpha-hexylcinnamicaldehyde. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence for skin hypersensitivity. A sensitization rate of 0% was determined. In this study creatine monohydrate is not a dermal sensitizer.
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