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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:
2010
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

Constituent 1
Chemical structure
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

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