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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 30/4/1996 to 2/7/1996
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
other: colorless fluid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
Sighting study:
2000 mg/Kg bw and 5000 mg/Kg bw
Main study:
5000 mg/Kg bw (10 mL/Kg bw
No. of animals per sex per dose:
Sighting study:
2 rats
Main study:
5 males and 5 females
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 of the test item in rats was found to be >5000 mg/Kg bw
Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in OECD Guidelines 420 "Fixed dose method" from 1992.

The study was initiated with a sighting study. On the basis of the results of the sighting study, it was decided to carry out main study with dose of 5000 mg /Kg bw with a group of 10 animals.

Eight animals of the main study survived the treatment and showed moderate signs of toxicity

Under the experimental conditions described, the oral LD50 of the test item in rats was found to be >5000 mg/Kg bw