Registration Dossier
Registration Dossier
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EC number: 200-274-3 | CAS number: 56-45-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology studies with N-acetyl-L-serine.
- Author:
- van de Mortel EL, Shen ZA, Barnett JF Jr, Krsmanovic L, Myhre A, Delaney BF
- Year:
- 2 010
- Bibliographic source:
- Food Chem Toxicol. 2010 Aug-Sep;48(8-9):2193-9
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
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:
- mouse
- Strain:
- ICR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- single oral gavage
- Frequency of treatment:
- once via a single oral gavage at a volume of 20 mf/kg bw
- Post exposure period:
- 24 h first experiment
48 h second experiment
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females per treatment group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide monohydrate
- Route of administration: oral gavage
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- femoral bone marrow cells
- Evaluation criteria:
- The incidence of micronucleated polychromatic erythrocytes per 10000 polychromatic erythrocytes per group (2000 PCEs per animal) served as a parameter of test substance genotoxicity.
- Statistics:
- Statistical analysis of data was performed with Kastenbaum-Bowmann tables (binominal distribution, p<=0.05, Kastenbaum and Bowman, 1970)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- PCE/total erythrocyte ratio not significantly changed
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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