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EC number: 200-568-1 | CAS number: 63-91-2
- 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
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- Flash point
- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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
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- Terrestrial toxicity
- Biological effects monitoring
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 1970 to 1971-09-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: An OECD or other international guideline for acute oral toxicity was not available at the the year of the study. The study is similiar to OECD 401.
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Groups of ten rats (five males and five females) were administered 0, 10 and 16g/kg bw L-phenylalanine and observed during two weeks for mortality.
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-phenyl-L-alanine
- EC Number:
- 200-568-1
- EC Name:
- 3-phenyl-L-alanine
- Cas Number:
- 63-91-2
- Molecular formula:
- C9H11NO2
- IUPAC Name:
- phenylalanine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carworth Europe, Alconbury, Huntingdon
- Weight at study initiation: 62 - 123 g
- Fasting period before study: 20 hours before dosing (and 4 hours after dosing)
- Housing: caged in groups according to sex and age
Administration / exposure
- Route of administration:
- other: Solution in water or as suspension in 1 % methyl cellulose and administered by gastric intubation.
- Vehicle:
- other: water or methyl cellulose plus water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30% solution in water or 30% suspension in 1% methyl cellulose
MAXIMUM DOSE VOLUME APPLIED:
Maximum dosage volume of 53.3 ml/kg bodyweight, equivalent to a maximum practical dose of 16g amino acid /kg bodyweight.
Dosage volumes in excess of 20 ml/kg were given in divided doses at two hourly intervals. - Doses:
- 0, 10 and 16 g/kg bw.
Rats dosed with the vehicle alone served as controls. - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight/behaviour - Statistics:
- Method of Litchfield J.T., Wilcoxon F (1949), J. Pharmac. exp. Ther. 96, 99
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 10 000 - <= 16 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 16 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: median Iethal oral dose
- Mortality:
- Three female rats died; one dosed at 10g/kg and two dosed at 16g/kg bw. Death occurred within 46 hours of dosing and was preceded by coma. Autopsy of animals that died did not reveal any specific cause of death.
- Clinical signs:
- other: Lethargie behaviour was observed shortly after dosing. Recovery of survivors, as judged by external appearance and behaviour was apparently complete within 3 days.
- Gross pathology:
- Autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute oral toxicity study was performed with groups of 5 male and 5 female rats. The results indicate that the median lethal oral dose (LD 50) of L-phenylalanine is ca. 16g/kg bw.
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