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Diss Factsheets
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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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Additional information
Creatine is an endogenous organic acid that occurs naturally in vertebrates and helps to supply energy to all cells in the body, primarily muscle. Creatine is part of the diet and can be present in meat and fish in concentrations of 2-7 g/kg. In addition it is used as food supplement to increase muscle weight. In 2004 the European Food Safety Authority (EFSA) published a record which stated that oral long-term intake of 3g pure creatine per day is risk-free (Question number: EFSA-Q-2003-125). Sub-acute repeated dose toxicity in rodents (28 day) and epidemiological data don’t raise concern with regards to the use of creatine as food supplement. The reports of damage to the kidneys by creatine supplementation have been scientifically refuted (Gualano, et al. (2008). Effects of creatine supplementation on renal function: a randomized, double-blind, placebo-controlled clinical trial. European Journal of Applied Physiology, 103(1), Number 1 (2008), 33-40; Kreider, et al (2003). Long-term creatine supplementation does not significantly affect clinical markers of health in athletes. Molecular and Cellular Biochemistry 244, 1-2; 95-104). Even though there is a broad range of data from epidemiological and sub-acute studies available data don’t cover all parameters that would be monitored in Reproduction/Developmental Toxicity Tests according to OECD 414 and OECD 421, respectively. However, conducting studies according to OECD 414 and 421 in rodents is not scientifically justified as the limit dose used in those tests (1000 mg/kg/d) would not exceed the amount of creatine present in the diet. This can be shown by the following assumptions: 1) Physiological concentration and diet: According to scientific literature a 70 kg person carries a physiological amount of 120 g creatine and metabolizes 2000 – 4000 mg creatine per day. Half of this amount (1000 – 2000 mg/person/d) is synthesized endogenously in the liver, kidney and pancreas. The other 1000 – 2000 mg/person/day are delivered via the diet. The amount of endogenously synthesized creatine decreases when more creatine is provided by the diet. Examples of food with a high content of creatine are fish (2000 - 10000 mg/kg), meat (4500 – 5000 mg/kg), or milk (100 mg/kg). 2) Experimental conditions & conclusion: The daily endogenous synthesis in humans is in the range of 14 – 28 mg creatine/kg body weight/d. The same amount is supplied by diet. Obviously, the daily turnover of 28 – 56 mg creatine/kg bw is of no concern for humans. To measure any detrimental effects in an animal model the applied dose would need to exceed this value. The standard assessment factor for converting data from Reproduction/Developmental Toxicity Tests to humans is 200 (AF2 for converting sub-chronic to chronic; and AF 100 for accounting intra- and interspecies variation). Thus to even reach the standard daily human turnover a dose of 5600 mg applied to rat would be necessary. 5600 mg/kg/d is far above the limit dose of 1000 mg/kg/d used in a standard OECD 414 and OECD 421 study, respectively. Conducting a study at limit dose in rats is thus not suited to derive any data on non-physiological conditions in humans. Thus a study according to OECD 414 and OECD 421 applying the limit or any lower dose is not scientifically justified. The same is true for studies on repeated dose toxicity (90-Day; OECD 408).
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Species:
- rat
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.