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Toxicological information

Genetic toxicity: in vivo

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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: published well documented GLP guideline study

Data source

Reference
Reference Type:
publication
Title:
Safety assessment of N-acetyl-L-threonine.
Author:
van de Mortel EL, Shen ZA, Barnett JF Jr, Krsmanovic L, Myhre A, Delaney BF.
Year:
2010
Bibliographic source:
Food Chem Toxicol. 2010 Jul;48(7):1919-25

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Thr (CAS No. 72-19-5)
- Analytical purity: 100 % (LC/MSD method)
- Other: supplier: Sigma-Aldrich (St.Louis, MO)

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: sterile water
- Amount of vehicle (if gavage or dermal): 20 ml/kg bw
Duration of treatment / exposure:
24 h and 48 h
Frequency of treatment:
a single oral gavage
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
500 mg/kg bw
Basis:

Remarks:
Doses / Concentrations:
1000 mg/kg bw
Basis:

Remarks:
Doses / Concentrations:
2000 mg/kg bw
Basis:

No. of animals per sex per dose:
10 male and 10 female / dose
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide

- Route of administration: oral gavage
- Doses / concentrations: 50mg/kg

Examinations

Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION: femoral bone marrow was collected, bone marrow smears were prepared and stained with May-Grunwald-Giemsa stain

METHOD OF ANALYSIS: The incidence of MPCEs per 10000 PCEs per group (2000 PCEs per each animal) served as parameter of genotoxicity.

OTHER:
Evaluation criteria:
The incidence of MPCEs per 10000 PCEs per group (2000 PCEs per each animal) served as parameter of genotoxicity.
Statistics:
Kastenbaum-Bowman tables (ninominal distribution, p

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
A single oral gavage of test substance at doses up to 2000 mg/kg bw did not induce a significant increase in the incidence of MPCEs in the bone marrow of male or female ICR mice.