Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V, B7
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
15, 150, 500 mg/kg bw/day
Basis:

No. of animals per sex per dose:
5 animals (Male or female) for each dose

Results and discussion

Results of examinations

Details on results:
Clinical observations:
500 mg/kg/day: salivation and urine staining. Decreased bodyweights and slightly decreased food consumption for males only. Slightly long tail flick response time and slightly reduced forelimb grip strenght.

150 mg/kg/day: salivation and urine staining. Decreased bodyweights for males only. Slightly long tail flick response time and slightly reduced forelimb grip strength for males.

Laboratory findings:
500 mg/kg/day: increased white blood cell counts and components of the count. Increased alanine aminotransferase and alkaline phosphatase (male only).

Effects in organs:
500 mg/kg/day: alightly increased liver weight. No histopathological changes.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Dose descriptor:
NOEL
Effect level:
15 mg/kg bw/day (nominal)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Not classified.