Registration Dossier

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:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Principles of method if other than guideline:
No guideline mentioned .
Method: other
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male
Details on test animals and environmental conditions:

Body weight average 30 g at the study initiation
Control animals: Distilled water 5 animals/sex

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Negative: Vehicle (Distilled water)
Positive: Triethanolamine 0.25 mg/kg b.w.
Frequency of treatment:
2 application, 24 h interval
Post exposure period:
6 h after second treatment
Doses / concentrations
Remarks:
Doses / Concentrations:
), 300, 1000, 3000 mg/kg b.w. was administered in two treatments with an interval of 24 h
Basis:

No. of animals per sex per dose:
60 males, 5 animals/sex/dose
Control animals:
yes
Positive control(s):
Positive: Triethanolamine 0.25 mg/kg b.w.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified

Any other information on results incl. tables

Genotoxicity :

The mean micronucleated cell count for all dose groups were essentially comparable with the concurrent vehicle control group.The positive control, triethanolamine induced a significant genotoxic response.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
There was no increase in the number of micronuclei in treated animals as compared to controls.
Piperonyl Butoxide was not genotoxic in the mouse micronucleus test in vivo.