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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
Endpoint summary
Administrative data
Description of key information
Based on the results of reliable studies on primary skin and eye irritation according OECD guideline 404 and 405, respectively,
Creatine monohydrate is considered to be not irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-9-16 to 1997-9-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: > 6 weeks
- Weight at study initiation: < 3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): standard laboratory rabbit diet
- Water (e.g. ad libitum): free access to tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance; moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- skin reactions were assessed at approximately 1, 24, 48 and 72 hours after removal of the dressings and test substance
- Number of animals:
- 3 of either sex
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm²
- Type of wrap if used: micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of dressing and of remaining test substance using a tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 1297
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 1298
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 1300
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 1297
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 1298
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 1300
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to creatine monohydrate. There was no evidence of a corrosive effect on the skin.
- Other effects:
- No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Creatine Monohydrate does not have to be classified and has no obligatory labelling requirement for skin irritation.
Creatine Monohydrate is not irritating. - Executive summary:
A primary dermal irritation study with creatine monohydrate in the rabbit (4-hour semi-occlusive application) was conducted based on the OECD guideline No. 404, "Acute Dermal Irritation/Corrosion".
Three male rabbits (at least 6 weeks old; weight: 1893-2069 g) were exposed to 0.5 grams of creatine monohydrate moistened with water (equivalent to 0.44 g creatine) to 2x3 cm clipped skin in the dorsal area for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. Irritation was graded according a numerical scoring system. No skin irritation was caused by 4 hours exposure to creatine monohydrate. In this study creatine monohydrate is not irritating to the skin and does not have to be classified.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
No edema and erythema after 4 hours of exposure; scoring of erythema and edema: for all three animals after 1, 24, 48 and 72 hours score 0.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-11-17 to 1997-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: individually in labelled cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days before start of the treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 69.8 +/- 0.5 mg (a volume of approximately 0.1 ml) - Duration of treatment / exposure:
- upon application eye closed for one second and subsequently not rinsed
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24,48 and 72 h after instillation of the test substance
- Number of animals or in vitro replicates:
- 3 animals of either sex
- Details on study design:
- SCORING SYSTEM: numerical scoring
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 1492
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 1494
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 1510
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 1492
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 1494
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 1510
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 1492
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 1492
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 1510
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Eyelids, Nictitating membrane
- Basis:
- animal #1
- Remarks:
- 1492
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Eyelids, Nictitating membrane
- Basis:
- animal #2
- Remarks:
- 1494
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 1510
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- There was no evidence of ocular corrosion. Remnants of the test substance were present in the eye of one animal and on the outside of the eyelid of another animal on day 1.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, creatine monohydrate does not have to be classified and has no obligatory labelling for eye irritation.0
Creatine monohydrate is not irritating. - Executive summary:
In a primary eye irritation study according to the OECD guideline 405 "Acute Eye Irritation/Corrosion" single samples of approximately 70 mg creatine monohydrate (a volume of approximately 0.1 ml) which is equivalent to 61.54 mg creatine (or 0.088 ml respectively) were instilled into the conjunctival sac of one eye of each of three male albino rabbits (New Zealand White; Source: Broekman Institute; at least 6 weeks old; body weight < 3.5 kg). The eyes were not washed. Observations were made 1, 24, 48 and 72 hours after instillation. Irritation was scored with a numerical scoring system. The irritation consisted of redness, chemosis and/or discharge, and had completely resolved within 24 hours in one animal and within 48 hours in the two other animals. Iridic irritation grade 1 was observed in two animals on day 1 only. In this study creatine monohydrate is not an eye irritant and does not have to be classified.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 1: Mean values of eye irritation scores (24, 48 and 72 h after instillation)
Animal No. |
Mean 24 – 72 hours |
|||
|
Corneal opacity |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
1492 |
0 |
0 |
0.3 |
0 |
1494 |
0 |
0 |
0.3 |
0 |
1510 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A primary dermal irritation study with creatine monohydrate in the rabbit (4-hour semi-occlusive application) was conducted based on the OECD guideline No. 404, "Acute Dermal Irritation/Corrosion".
No skin irritation was caused by 4 hours exposure to creatine monohydrate. In this study creatine monohydrate is not irritating to the skin and does not have to be classified.
An eye irritation study according to the OECD guideline 405 "Acute Eye Irritation/Corrosion" was conducted. The irritation consisted of redness, chemosis and/or discharge, and had completely resolved within 24 hours in one animal and within 48 hours in the two other animals. Iridic irritation grade 1 was observed in two animals on day 1 only. In this study creatine monohydrate is not an eye irritant and does not have to be classified.
Justification for classification or non-classification
Based on the available data Creatine monohydrate is considered to not irritating to the skin and eye.
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