Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
other: Crl CDBR
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Single dose of 5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females at 5000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical obserbations made over 14 day period. Bodyweight assessed periodically throught study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities (0/5) in males treated at 5000 mg/kg.
No mortalities (0/5) in females treated at 5000 mg/kh/
Clinical signs:
Signs of toxicity related to dose levels: The only sign of toxicity was soft stool in two females on the day of treatment.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
Effects on organs: At necropsy, the spleen in one male was observed to have two 5 mm in diameter, white areas and the left testis in a second male was observed to be small when compared to the right testis. These were considered incidental findings and unrelated to the test material. There were no visible lesions in any of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 is >5000 kg/mg in rats of both sexes.
Executive summary:

The study was conducted in accordance with OECD Guideline No. 401.

The test material was administered to 10 Crl:CD BR rats (5 per sex) by oral gavage, at a single dose of 5000 mg/kg in corn oil. Clinical observations were made over a 14 -day period.

No deaths occurred during the observation period. All rats were sacrificed on day 14 and necropsy performed. Bodyweight gains of the treated animals were unaffected by treatment. Clinical signs of toxicity were limited to soft stool in two females on the day of treatment. Necropsy on sacrificed animals revealed no treatment-related macroscopic lesions/

Results of the study indicate an acute oral LD50 of >5000 mg/kg in rats of both sexes for the test material.