Registration Dossier
Registration Dossier
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EC number: 200-774-1 | CAS number: 72-19-5
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:
- 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:
- 2 010
- Bibliographic source:
- Food Chem Toxicol. 2010 Jul;48(7):1919-25
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- L-threonine
- EC Number:
- 200-774-1
- EC Name:
- L-threonine
- Cas Number:
- 72-19-5
- Molecular formula:
- C4H9NO3
- IUPAC Name:
- L-threonine
- 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)
Constituent 1
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.
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