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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-13 to 2011-09-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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
- Reference substance name:
- Creapure
- IUPAC Name:
- Creapure
- Details on test material:
- - Name of test material (as cited in study report): Creatine monohydrate
- Molecular formula (if other than submission substance): C4H11N3O3
- Substance type: organic
- Physical state: solid; colourless, white powder
- Analytical purity: >= 99 %
- Purity test date: 2011-03-21
- Lot/batch No.: 108131
- Expiration date of the lot/batch: 2014-03-21
- Stability under test conditions: According to the sponsor, the stability of the test item is guaranteed throughout the study period when stored under the
conditions stated.
- Storage condition of test material: In the refrigerator (2 – 8°C)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
- Weight at study initiation: males (mean): 282.2 g; females (mean): 230.4 g
- Fasting period before study: not reported
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean of 20.92 °C
- Humidity (%): Mean of 56.72 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10 % of the estimated body surface
- % coverage: 10
- Type of wrap if used: cellulose patch (Pehazell, Hartmann AG), non irritating tape (Blenderm Wundpflaster, 3M), semi-occlusive dressing (Fixomull Stretch, Fa. Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none; Residual test substance was wiped off using wet cellulose tissue, if necessary.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The amounts of the test substance were calculated and weighed for each individual using the body weight determined on the day of the administration.
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, 7 days p.a., 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, body weight gain; changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions - Statistics:
- none
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 to 1758.36 mg/kg body weigh Creatine (anhydride)
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: General findings: All animals did not show any clinical signs during the entire observation period. Observations of skin condition: Exposed skin was not found to be altered by the test substance.
- Gross pathology:
- No abnormal findings were made in the animals at terminal necropsy.
Any other information on results incl. tables
Table 1: Body weights and body weight gain.
Individual data, mean and standard deviation SD.
Dose sex |
Animal No. |
Body weight (g) |
Body weight gain (g) |
||||
2000 mg/kg male |
before administr |
7 days p.a. |
14 days p.a. |
death |
0-7 days p.a. |
7-14 days p.a. |
|
121 |
283 |
323 |
366 |
- |
40 |
43 |
|
122 |
295 |
335 |
378 |
- |
40 |
43 |
|
123 |
271 |
300 |
348 |
- |
29 |
48 |
|
124 |
277 |
296 |
334 |
- |
19 |
38 |
|
125 |
285 |
318 |
352 |
- |
33 |
34 |
|
Mean |
282.2 |
314.4 |
355.6 |
- |
32.2 |
41.2 |
|
SD |
9.0 |
16.3 |
16.9 |
- |
8.8 |
5.4 |
|
2000 mg/kg female |
126 |
226 |
251 |
269 |
- |
25 |
18 |
127 |
240 |
245 |
258 |
- |
5 |
13 |
|
128 |
232 |
233 |
240 |
- |
1 |
7 |
|
129 |
226 |
230 |
239 |
- |
4 |
9 |
|
130 |
228 |
243 |
252 |
- |
15 |
9 |
|
Mean |
230.4 |
240.4 |
251.6 |
- |
10.0 |
11.2 |
|
SD |
5.9 |
8.7 |
12.6 |
- |
9.9 |
4.4 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight. No mortality occurred.
- Executive summary:
In an acute dermal toxicity study according the OECD guideline 402 groups of young adult rats (Crl:CD(SD)) (5/sex) were dermally exposed to Creatine Monohydrate (>=99 %) for 24 hours to 10 % of the body surface area at doses of 2000 mg/kg bw (limit test). Animals then were observed for 14 days. No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. No mortality occurred. A dermal LD50 (males/females) > 2000 mg/kg body weight was determined. From the results of this study no classification is derived for Creatine Monohydrate according to the Directive 2001/59/EC.
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