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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:
2003-05-05 to 2003-05-27
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Colourless liquid
Details on test material:
Bernel Ester TCC (Tricapryl Citrate) Lot #1585
100%
Test substance was expected to be stable for the duration of testing

Test animals

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.

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.