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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was administered neat by oral gavage to one male rat each at dosages of 450, 670, 1000, 1500, 2300 or 3400 mg/kg.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Test material form:
liquid
Details on test material:
- Purity: Not reported

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
450, 670, 1000, 1500, 2300 or 3400 mg/kg
No. of animals per sex per dose:
1
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD0
Effect level:
> 3 400 mg/kg bw
Based on:
test mat.
Other findings:
At necropsy, the livers were enlarged while the testes and accessory sex organs were small. Microscopic examination revealed minimal to mild centrilobular hypertrophy and midzonal fatty change in livers and minimal to moderate degeneration/atrophy of seminiferous tubules in the testes. While the lesions in the liver were considered test substance-related, the testicular changes could be related to either the test substance, the marked body weight losses during the test period, or a combination of both.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 3400 mg/kg
Executive summary:

The test substance was administered neat by oral gavage to one male rat each at dosages of 450, 670, 1000, 1500, 2300 or 3400 mg/kg. Under the conditions of this test, the approximate lethal dose was greater than 3400 mg/kg. The death of the rat treated with 1500 mg/kg was attributed to animal variability since the rats treated at 2300 and 3400 mg/kg survived the study. At necropsy, the livers were enlarged while the testes and accessory sex organs were small. Microscopic examination revealed minimal to mild centrilobular hypertrophy and midzonal fatty change in livers and minimal to moderate degeneration/atrophy of seminiferous tubules in the testes. While the lesions in the liver were considered test substance-related, the testicular changes could be related to either the test substance, the marked body weight losses during the test period, or a combination of both.