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EC number: 200-273-8 | CAS number: 56-41-7
- 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
An acute oral LD50 value of > 5110mg/kg bw from a reliable study was derived. No mortality occurred during the observation period of 14
days. No signs of toxicity were observed either at the male nor the female animals.
The acute dermal study and the acute inhalation study were waived based on the very low systemic toxicity as well as on the physico-chemical and toxikokinetic properties.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-03-11 to 1983-03-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Guideline:
- other: No guideline available at that time
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Intercomparison study on the determination of single administration toxicity in rats, Commission of the European Communities, Health and Safety Directorate, J. Assoc. Off. Anal. Chem. 62, 864-73, 1979
- GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 52 days, females 66 days
- Weight at study initiation: males 0.134 - 0.139 kg, females 0.127 - 0.133 kg
- Fasting period before study: 16 hours
- Housing: Makrolon cages type II
- Diet (e.g. ad libitum): standardised test animal diet ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days acclimatisation period before study begin
ENVIRONMENTAL CONDITIONS
According to method
IN-LIFE DATES: From: To: no data available - Route of administration:
- oral: gavage
- Vehicle:
- other: Tragant
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 238 mg/ml
- Amount of vehicle (if gavage): 21.5 ml/kg
- Justification for choice of vehicle: solubilty, inherent vehicle
- Lot/batch no. (if required): not applicable
- Purity: ca. 100 %
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg - Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: no data vailable - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the observation period of 14 days.
- Clinical signs:
- other: No signs of toxicity were observed, neither at the male nor the female animals.
- Gross pathology:
- no data available
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 value of L-alanine via the oral route represented by male and female rats was > 5110 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 110 mg/kg bw
- Quality of whole database:
- Comparable to guideline study with acceptable restrictions (Klimisch Code 2)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No acute toxic effects were observed for the oral route up to the maximum dose of 5110 mg/kg body weight. The LD50 value of L-alanine via the oral route represented by male and female rats was > 5110 mg/kg body weight. These results show that the toxicity of L-alanine via the oral route is extremely low.
No acute toxic effects were observed for the oral route for single or repeated oral doses of 50 g L-alanine per subject in three human studies (Genuth 1973; Koeslag et al 1985a and 1985b).
Citations:
Genuth S.M. Effects of oral alanine administration in fasting obese subjects. Metabolism. 1973 Jul; 22(7): 927-37;
Koeslag, J.H., Levinrad, L.I., Klaff, L.J., 1985a. Pancreatic polypeptide response to exercise: effect of alanine and glucose ingestion in carbohydrate-starved athletes. S. Afr. Med. J. 67, 884–887;
Koeslag, J.H., Levinrad, L.I., Lochner, J.D., Sive, A.A., 1985b. Postexercise ketosis in post-prandil exercise: effects of glucose and alanine ingestion in humans. J. Physiol. 358, 395–403.
Justification for selection of acute toxicity – oral endpoint
Key study
Justification for classification or non-classification
Based on the data available no classification for acute toxicity (oral toxicity, dermal toxicity, inhalation toxicity) is required.
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