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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-05-05 to 2003-05-27
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
5 female rats, 9-10 weeks old (160-192g) at experimental start. Housed singly. Temperature range 20-24C with 12/12 hour light/dark cycle.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing.
Doses:
single oral dose at 2,000 mg/kg bw
No. of animals per sex per dose:
5 female
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None observed
Body weight:
Gained weight and appeared active and healthy
Gross pathology:
unremarkable
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.
Executive summary:

5 female rats were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing. All animals survived and gained bodywieght. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed. Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification