4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate

EC Number:

700-641-2

Cas Number:

1261240-30-5

Molecular formula:

C37H46O5

IUPAC Name:

4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate

Test material form:

other: Crystalline powder

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

Age and body weight range of test animals: nine weeks old and 227 to 235 grams.
Number and sex: a total of 6 females were used in this study. Animals were quarantined and acclimated for 6 days prior to study. Ear-notch and cage tags were used for animal identification. Each cage was identified by a card indicating cage number, study number , dose level, sex and animal IDs.
Environmental conditions: The animals were housed individually in a Polycarbonate (PC) cage (three rats per cage). The animals were housed in room C438 for three days, then transferred to room C411 due to the air pressure problem. The daily mean temperature was 20.6 - 21.3 degree C in C438 and 20.5 - 21.5 degree C in C411. The daily mean relative humidity was 50.8 - 57.3% in C438 and 29.2 - 58.6% in C411. THe 12-hr/12-hr light/dark cycle with light on at 6:00 AM and off at 6:00 PM was maintained.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methyl Cellulose at 0.5% (w/v) was used for dosing formulation preparation.

Doses:

The starting dose of 2000 mg/kg was used.

No. of animals per sex per dose:

6

Details on study design:

Three female animals were used for the starting dose of 2000 mg/kg. Because neither mortality nor body weight loss over 20% was observed within 3 days, three more females were administered at the same dose. Total 6 animals were administered test article formulation at dose of 2000 mg/kg with concentration of 100 mg/mL. The dosing volume was 20 mL/kg.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal death was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross lesion was observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

After the animals were administered to the dose level of 2000 mg/kg, neither animal death nor clinical sign was found during the entire study period. The body weights were increased during the study period. At animal necropsy, no gross lesion was found in all rats. Based on the data obtained from this study, the test substance would be assigned to GHS Category 5/unclassified and the harmonized LD50 cut-off values is 5000 mg/kg.