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Toxicological information

Repeated dose toxicity: oral

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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
Guideline:
other: Directive 96/54/EC, B.7.
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: Rat, F344 Fischer.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Water. An aqueous solution of the test substance was used in the dosed groups.
Details on oral exposure:
Method of administration:
Stomach intubation.
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 20 mg/kg bw/day
Male: 5 animals at 65 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 20 mg/kg bw/day
Female: 5 animals at 65 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality: none in any group.

Observations in life, clinical and functional observations:
There were no test substance related effects.

Body weight gain: No relevant changes were observed,
compared to the control.

Feed consumption: No relevant changes were observed,
compared to the control.

Laboratory findings:
Haematology: No relevant changes were observed, compared to
the control.

Blood chemistry: No relevant changes were observed, compared
to the control.

Effects in organs:
Necropsy: no relevant findings.

Organ weights: no relevant findings.

Histopathology: no relevant findings.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
200 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
200 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