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EC number: 206-126-4 | CAS number: 302-72-7
- 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
Acute oral toxicity study, 10 rats (male/female), result: LD50 > 16000 mg/kg bw
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No OECD testing guideline was available at that time - study was generally carried out as a limit test as described in OECD 403 but at a higher dose level than 5 g/kg bw, and a control group was also included
- GLP compliance:
- no
- Remarks:
- GLP did not exist at that time
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rats of the CFY strain were obtained from Carworth Europe, Alconbury, Huntingdon. At the time of dosing they were in the weight range of 62 to 123 g. Each animal was deprived of food for a period of 20 hours prior to dosing, after which food was withheld for a further four hours. Throughout the subsequent observation period of two weeks, they were caged in groups according to sex and dosage.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- The test substances were prepared as 30% solution in water or as 30% suspension in 1% methyl celluloe. Since DL-alanine is water soluble the application as a solution in water is likely.
- Details on oral exposure:
- The twenty five amino acids were prepared as 30% solutions in water or as 30% suspensions in 1% methyl cellulose and administered by gastric intubation at a maximum dosage volume of 53.3 mL/kg bodyweight. This gave a maximum practical dose of 16 g amino acid /kg body weight. Rats dosed with the vehicle alone served as controls. Dosage volumes in excess of 20 mL/kg were given in divided doses at two hourly intervals.
- Doses:
- 16 g amino acid / kg bodyweight
- No. of animals per sex per dose:
- Ten rats (five males and five females) were dosed at 16 g/kg bodyweight.
- Control animals:
- yes
- Details on study design:
- The test animals were deprived of food for a period of 20 hours prior to dosing, after which food was withheld for a further four hours. Throughout the subsequent observation period of two weeks, they were caged in groups according to sex and dosage. The test substance was prepared as a 30% solution and administered by gastric intubation at a maximum dosage volume of 53.3 ml/kg bodyweight. This gave a maximum practical dose of 16 g amino acid /kg body weight. Rats dosed with the vehicle alone served as controls. Dosage volumes in excess of 20 ml/kg were given in divided doses at two hourly intervals.
During the observation period, a record was kept of all mortalities and signs of toxicity. During the observation period (two weeks), a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and animals surviving terminally were similarly examined to detect possible residual damage.
Assessment of degree of recovery from the initial toxic action of the product was made subjectively from appearance and behaviour of the animals and, more objectively, by weekly checks on bodyweight. - Statistics:
- Not applicable.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female rat died seven hours after dosing. Autopsy did not reveal any specific cause of death.
- Clinical signs:
- other: none
- Gross pathology:
- No findings
- Other findings:
- Lethargic behaviour was the only sign of reaction to treatment.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The LD50 of D,L-alanine for acute oral toxicity in rats was determined to be > 16 g/kg bw.
- Executive summary:
In an acute oral toxicity study, ten CFY rats (five males and five females) were given a single dose of D,L-alanine at 16 g/kg bw. Lethargic behaviour was the only sign of reaction to treatment. One female was found dead 7 h after treatment. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within 24 hours. This observation was substantiated by normal bodyweight increases, except for a slight depression amongst treated females during the first week. The median lethal oral dose (LD50) was greater than 16 g/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- Good quality due to study according to international standards.One animal out of 10 was found dead 7 h after treatment.
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
Acute oral toxicity
In an acute oral toxicity study (key study), ten CFY rats (five males and five females) were given a single dose of DL-alanine (16 g/kg bw). Lethargic behaviour was the only sign of reaction to treatment. One female was found dead 7 h after treatment. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within 24 hours. This observation was substantiated by normal bodyweight increases, except for a slight depression amongst treated females during the first week. The median lethal oral dose (LD50) was greater than 16 g/kg bodyweight.
Justification for classification or non-classification
The LD50oral of > 16000 mg/kg bw of the substance DL-alanine has been assessed in a well conducted acute oral toxicity on rats, and was supported by 2 other acute oral toxicity studies with other amino acids. No classification for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP Regulation) is warranted.
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