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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 November 2001- 20 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Qualifier:
according to guideline
Guideline:
other: EEC Directive 96/54/EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
00945
IUPAC Name:
00945
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
Once daily for at least 28 days, 7 days a week, approximately the same time each day with a maximum of 4 hours difference between the earliest and latest dose. Animals were dosed up the the day prior to necropsy.
No. of animals per sex per dose:
20 males and 20 females
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
The test substance was administered daily for 28 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 males and 5 females.

Effect levels

open allclose all
Dose descriptor:
dose level:
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related findings noted
Dose descriptor:
dose level:
Effect level:
150 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Slightly reduced body weight
Dose descriptor:
dose level:
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Slightly reduced body weight

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOEL > 1000mg/kg bw/day
Executive summary:

Wistar rats were treated with the test substance for 28 consecutive days by oral gavage at does level up to 1000 mg/kg/day.

A slight reduction of body weight was obtained for high dose animals and for group 3 males in the second half of the treatment period when compared to (historical) controls, but occured without a concurrent reduction of food consumption. Since a clear dose related response was absent, this change was considered to be of doubtful tocicological relevance.

Changes of some clinical biochemistry parameters noted in some group 3 and 4 animals were not accompanied by supportive treatment- related microscopic abnormalities. Also, most values of these groups remained comparable values of other studies. Therefore, these changes were considered to be without toxicological importance.

There were no changes at determination of clinical appearance, performance of functional observations, food consumption measurements, or alterations during haematological investigations, macroscopic examination, organ weight determination and microscopic examination that were considered to be an effect of treatment.