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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Method B7 of directive 92/69/EEC and Japanese Ministry of Health and Welfare (MHW) and Ministry of International Trade and Industry (MITI) Guideline 1986.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat (Sprague-Dawley)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Polyethylene glycol 400
Details on oral exposure:
Method of administration:

gavage
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day

Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clincal observations:
No clinical observable signs of toxicity were detected in test or control animals throughout the study. No adverse effects on body weight gain, food consumption or water consumption were observed.

Laboratory findings:
No treatment realted effects were observed in hematology, blood chemistry or urinalysis.

Effects in organs:
No effect on organ weights were detected and no macroscopic abnormalitites were observed at necropsy. No treatment related findings were observed during histopathology.

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:
1 000 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.