Registration Dossier
Registration Dossier
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EC number: 500-465-4 | CAS number: 160901-28-0 1 - 2.5 moles ethoxylated
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 68891-38-3 (purity 27-29%)
- IUPAC Name:
- 68891-38-3 (purity 27-29%)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water
- Duration of treatment / exposure:
- n.a.
- Frequency of treatment:
- Once
- Post exposure period:
- test group: 10, 24 and 48 h
positive control: 26 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (50 mg/kg bw)
Examinations
- Tissues and cell types examined:
- Femoral bone marrow cells
- Details of tissue and slide preparation:
- SAMPLING TIMES
test groups: 10, 24 and 48 h after treatment
positive control group: 26 h after treatment - Evaluation criteria:
- According to Guideline.
- Statistics:
- Yes
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative
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