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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:
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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.