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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study, animal experimental study with minor restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Principles of method if other than guideline:
Peripherable blood taken after 13 week continuous feeding fo rats to up to 40,000 ppm in DBP in the diet. - detailed in MacGregor et al (1990)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
> 99% pure

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Examinations

Statistics:
The frequency of micronucleated cells among normochromatic erythrocytes was analyzed by a statistical software package (ILS, 1990) that employed a one-tailed trend test across exposure groups and a t-test for pairwise comparisons of each exposure group to the concurrent control.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid

Any other information on results incl. tables

Analyses of peripheral blood samples taken from male and female mice at the end of the 13-week study revealed no increased incidences of micronucleated normochromatic erythrocytes in males or females.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
DBP did not cause an increased incidences of micronucleated normochromatic erythrocytes in males or female rats after a 13 week dosing period.