Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Version / remarks:
(12.05.81)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Version / remarks:
(25.04.1984)
Deviations:
not specified
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Tif:RAIf (SPF)
Strain:
other: F3-hybrid of RII 1/Tif x RII 2/Tif
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% CMC and 0.1% Tween80
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
1 dose per day, 7 times per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 40, 200 and 1000 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
200 other: mg/kg bw/day
Based on:
not specified
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Signs of toxicity related to dose levels, and including haemathology and clinical chemistry findings:

- No clinical symptoms and no signs of systemic toxicity were observed during the treatment. - Haematology: A minor increase in the % of segmented neutrophils was found in m and f of the 1000 mg/kg bw dosage group but without statistical significance. - Blood chemistry: Only a minor increase in aspartate aminotransferase activity (statistically not significant ) was observed in the m group 4, treated with 1000 mg/kg bw. Effects on organs: - (gros and microscopic) related to dose level: Neither macroscopical nor microscopical findings revealed evidence of a reaction to the treatment.

Applicant's summary and conclusion

Conclusions:
NOAEL = 200 mg/kg bw/day (in rats of both sexes)