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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:
23 September 1987 - 7 October 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "OECD Short term and long term toxicology groups final report" adopted in May 1981
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, Michigan
- Age at study initiation: 'young'
- Weight at study initiation: 237 +/- 18 grams
- Fasting period before study: ca. 18 hours prior to administration of test material
- Housing: All rats were housed individually in conventional design stainless steel, wire mesh bottom cages.
- Diet: Purina Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: All animals were weighed 24 hours, 7 and 14 days after administration of the test material. The animals were observed frequently on the first day of dosing and twice a day thereafter, at least 4 hours apart during weekdays. Individual observations for mortalities and behaviour or other reactions were made for each animal.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: A complete gross pathologic examination was performed on all rats at the termination of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No visible changes in animal behaviour or any signs of toxicity were observed.
Body weight:
No obvious effects on body weight gains were noted.
Gross pathology:
Terminal sacrifice of the animals did not reveal any gross pathological alterations in the organs and tissues examined.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An LD50 value of >5000 mg/kg was reported in a study carried out according to current guideline and in compliance with GLP.