Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US-EPA-FIFRA section 158.340 Guideline 84-2
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Boric acid
EC Number:
233-139-2
EC Name:
Boric acid
Cas Number:
10043-35-3
Molecular formula:
H3BO3
IUPAC Name:
Boric acid

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Distilled water.
Details on exposure:
Mice given two doses (in 10 mL distilled water) by gavage.

Duration of treatment / exposure:
2 days.
Frequency of treatment:
Animals dosed once per day.
Post exposure period:
No data
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
225 mg/kg bw/day (actual dose received)
Dose / conc.:
450 mg/kg bw/day (actual dose received)
Dose / conc.:
900 mg/kg bw/day (actual dose received)
Dose / conc.:
1 800 mg/kg bw/day (actual dose received)
Dose / conc.:
3 500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
No data
Control animals:
not specified

Examinations

Tissues and cell types examined:
No data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Clinical signs included rough fur and haunched position.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
The test substance was not genotoxic.