Registration Dossier
Registration Dossier
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EC number: 930-857-4 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Specific details on test material used for the study:
- 2-(ter-butylamino)-1-(3-chloro-4-hydroxy-5-chloromethylphenyl)ethanone HCl
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: ip, single
- Vehicle:
- 0.9% NaCl
- Frequency of treatment:
- single dose
- Post exposure period:
- 44h-68h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 125 mg/kg bw (total dose)
- Remarks:
- (0.5 MTD)
- Dose / conc.:
- 250 mg/kg bw (total dose)
- Remarks:
- (1 MTD)
- No. of animals per sex per dose:
- 5
- Positive control(s):
- 40 mg/kg bw Cyclophosphamide
Examinations
- Tissues and cell types examined:
- pheripheral bloods, immature erythrocytes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- only in the highest dose group evaluated (1MTD) signs of systemic tox were observed up to 44 h after bt not after 68h after the treatment
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- It can be stated that during the study the substance did not induce structural and/or numerical chromosomal demage in the immature erytrocytes of the mouse. therefore the substance is consider to be non-mutagenic in the Mammalian Erytrocyte Micronucleus Test
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