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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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997-9-10 to 1997-8-27
- 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:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- route of dosing intraperitoneal instead of oral
- Principles of method if other than guideline:
- Route of dosing intraperitoneal instead of oral.
- GLP compliance:
- yes
- 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 %
- Purity test date: 1997-7-29
- Lot/batch No.: CRT 197
- Expiration date of the lot/batch: 1998-6-19
- Stability under test conditions: at least 96 h
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: male mean: 31 g; female mean 26 g
- Housing: group housing of 3 animals per sex per cage
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- - Concentration in vehicle: 1 g of the ground substance was dissolved in 9 ml distilled water
- Justification for choice of vehicle: the vehicle was selected based on information provided by the sponsor
DOSAGE PREPARATION: the test substance was ground and filled in a syringe; 9 ml of water was drawn into the syringe and thoroughly shaken to prepare the suspension; the formulation was administered immediately after preparation
- MAXIMUM DOSE VOLUME APPLIED: 0.66 ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test - Doses:
- 2000 mg/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: body weights were determined on day 1 (pre-adminsitration) and on day 8 and 15; observations of clinical signs was monitored in periodic intervals on the day of dosing (day 1) and once daily thereafter
- Necropsy of survivors performed: yes - Statistics:
- no statistical analysis was performed (the method is not intended to allow the calculation of a precise LD50 value)
Results and discussion
Effect levels
- 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 (anhydride)
- Mortality:
- No mortality occurred
- Clinical signs:
- No clinical signs of toxicity were noted in the animals
- Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
- Other findings:
- none
Any other information on results incl. tables
Table 1: Body weights and individual dose volume (ml)
Group/sex |
Animal |
Day 1 |
Dose volume |
Day 8 |
Day 15 |
Group 1/ Males (2000 mg/kg) |
1 |
30 |
0.60 ml |
33 |
36 |
2 |
33 |
0.66 ml |
36 |
39 |
|
3 |
31 |
0.62 ml |
33 |
34 |
|
Mean |
31 |
|
34 |
36 |
|
St. Dev. |
2 |
|
2 |
3 |
|
n |
3 |
|
3 |
3 |
|
Group 1/ Females (2000 mg/kg) |
4 |
26 |
0.52 ml |
29 |
33 |
5 |
25 |
0.50 ml |
28 |
30 |
|
6 |
27 |
0.54 ml |
28 |
30 |
|
Mean |
26 |
|
28 |
31 |
|
St. Dev. |
1 |
|
1 |
2 |
|
n |
3 |
|
3 |
3 |
Applicant's summary and conclusion
- Conclusions:
- The intraperitoneal LD50 value of Creatine Monohydrate in mice was established as exceeding 2000 mg/kg body weight. As none of the animals died the LD0 of Creatine Monohydrate is 2000 mg/kg body weight. This equals to 1758.36 mg/kg bw Creatine (anhydride).
- Executive summary:
The intraperitoneal toxicity of Creatine Monohydrate was assessed in a limit test based on the OECD guideline 423 in mice (strain CD-1) except the route of dosing which was intraperitoneal instead of oral. Creatine monohydrate was administered once as a suspension in deionized water by intraperitoneal injection to three mice of each sex at a dose of 2000 mg/kg body weight. Animals were subjected to daily observation and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred and no clinical signs were observed. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination. The intraperitoneal LD50 value of creatine monohydrate in mice was established as exceeding 2000 mg/kg body weight. As none of the animals died the LD0 is exceeding 2000 mg/kg body weight.
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