Registration Dossier
Registration Dossier
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EC number: 200-274-3 | CAS number: 56-45-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Kouseisho-21 Yakuhatsu-424
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- L-serine
- EC Number:
- 200-274-3
- EC Name:
- L-serine
- Cas Number:
- 56-45-1
- Molecular formula:
- C3H7NO3
- IUPAC Name:
- L-serine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Sprague-Dawley strain SPF rats [Crl:CD(SD)]
- Test period: 2007.10.17 - 2008.01.31
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- L-Serine was administrated once each to groups of 5 males and 5 female Sprague-Dawley strain SPF rats [Crl:CD(SD)] at one dose level of
2,000 mg/kg.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred in males and females in any test article group. Therefore, the lethal dose level was estimated to be higher than 2,000 mg/kg for
L-serine. - Clinical signs:
- other: There were no abnormalities in clinical signs in any male or female animal during the observation period.
- Gross pathology:
- There were no abnormalities in the external appearance, or in organs/tissues in the cranial, thoracic or abdominal regions in any male or female
animals.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of the study report, it was estimated that the toxicity of L-serine was extremely low.
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