Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle used: DMSO
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
Twice with 24 hr interval
Frequency of treatment:
Twice with 24 hr interval
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
Dose / conc.:
2 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Micronuclei in red blood cells.from bone marrow.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Vehicle controls validity:
valid
Additional information on results:
Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.

Applicant's summary and conclusion

Conclusions:
Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.