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Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Principles of method if other than guideline:
- EC Directive 96/54/EEC, B.7 Repeated Dose (28 days)
Toxicity (oral), 1996.

- OECD 407, Repeated Dose 28-day Oral Toxicity Study in
Rodents, 1995

- OPPTS 870.3050, Repeated dose 28-day oral toxicity study
in rodents. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-00-366, 2000.
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: Rat, Wistar Crl:(WI) BR

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
propylene glycol
Details on oral exposure:
Method of administration:
Gavage
Duration of treatment / exposure:
Test duration: 28 days
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no changes in clinical appearance, performance of
functional observations, body weight and food consumption
measurements that were considered to be of toxicological
significance.

Laboratory findings:
There were no changes or alterations during haematological
investigations that were considered to be of toxicological
significance.

Effects in organs:
There were no changes in macroscopic examination that were
considered to be of toxicological significance.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
< 50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified

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