Registration Dossier
Registration Dossier
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EC number: 284-325-5 | CAS number: 84852-15-3
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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only abstract available; assessed in EU RAR 2002
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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
- Reference substance name:
- Nonylphenol
- EC Number:
- 246-672-0
- EC Name:
- Nonylphenol
- Cas Number:
- 25154-52-3
- IUPAC Name:
- 2-nonylphenol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 5
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- LD50: 307 mg/kg/day
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Because of doubts regarding the extent of exposure of the target tissue, only limited significance can be given to this negative result.
- Executive summary:
There were no increases in the frequency of micronuclei at any of the sampling times and the test was declared negative. The PCE/NCE ratio was not affected by nonylphenol, which raises concerns about adequacy of exposure of the bone marrow to the test substance. The toxicokinetic information suggests that the systemic bioavailability of nonylphenol following oral administration is restricted, which adds to this concern.
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