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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Repeated dose oral toxicity in rodent 28 day study. OECD method no 407, May 12 1981, and Annex to 92/69/EEC 31/7 92 part B.7.
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: SPF rat 20 males and 20 females of stock MOL: WIST
Strain:
other: SPF rat stock MOL: WIST
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results of examinations

Details on results:
Clinical observations: There were no clinical signs caused by the treatment.
No deaths occured. Laboratory findings: The precentage of gamma globulins in the male rats group 4 was lower than that in the male rats in the control group. No difference was seen in the female rats and the difference was considered incidental. No other differences between groups were seen for the clinical chemical parameters. Effects in organs: None

Effect levels

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