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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-8-27 to 1997-9-10
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
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: solid, white crystals
- Analytical purity: 101.8%
- Lot/batch No.: CRT 197
- Expiration date of the lot/batch: 1998-6-19
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: at least 96 h
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 6 weeks old
- Weight at study initiation: female: average 145 g; male: average 180 g
- Fasting period before study: overnight prior to dosing until approximatetly 3-4 hours after administration of the test substance
- Housing: 3 animals per sex per cage
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 g test substance per 9 ml of water
- Justification for choice of vehicle: The vehicle was selected based on information provided by the sponsor
DOSAGE PREPARATION (if unusual): substance was ground into fine powder and 1 g was filled into the tube of a syringe; 9 ml water was drawn in; the syringe was shaken thoroughly to prepare the suspension; the suspension was administered immediately after preparation - Doses:
- 2000 mg/kg (20ml/kg) body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations of clinical signs once daily; body weight: day 1 (pre-administration, 8 and 15)
- Necropsy of survivors performed: yes - Statistics:
- no statistical analysis was performed
Results and discussion
- Preliminary study:
- n.a.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- equals 1758.36 mg/kg bw Creatine (anhydrous)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- equals 1758.36 mg/kg bw Creatine (anhydrous)
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No clinical signs were detected
- Gross pathology:
- No abnormalities were found
- Other findings:
- none
Any other information on results incl. tables
Table 1: Body weights (gram)
Group/Sex |
Animal |
Day 1 |
Day 8 |
Day 15 |
Group 1/ Males (2000 mg/kg) |
1 |
184 |
245 |
284 |
2 |
188 |
243 |
292 |
|
3 |
169 |
218 |
252 |
|
Mean |
180 |
235 |
276 |
|
Standard deviation |
10 |
15 |
21 |
|
n |
3 |
3 |
3 |
|
Group 1/ Females (2000 mg/kg) |
1 |
147 |
177 |
203 |
2 |
144 |
178 |
194 |
|
3 |
144 |
192 |
223 |
|
Mean |
145 |
182 |
207 |
|
Standard deviation |
2 |
8 |
15 |
|
n |
3 |
3 |
3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of creatine monohydrate in Wistar rats was established as exceeding 2000 mg/kg body weight. The corresponding LD50 of creatine is > 1758.36 mg/kg body weight.
- Executive summary:
To assess the oral toxicity of creatine monohydrate a limit test based on the OECD guideline No. 423 "Acute oral toxicity-Acute toxic class method" was carried out. Creatine monohydrate in distilled water (1 g per 9 ml) was administered by oral gavage to three approx. 6 week old, fasted Wistar rats of each sex at a dose of 2000 mg/kg body weight. The animals were observed for 15 days. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occurred and no clinical signs were noted. Body weight gain was considered as normal. No abnormalities were found at the macroscopic post mortem examination. The oral LD50 value of creatine monohydrate in Wistar rats was established as exceeding 2000 mg/kg body weight.
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