Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6/18/1980 - 7/02/1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP, non-guideline study, only 4 animals used, with QAU statement

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

but QUA statement included

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

EC Number:

228-985-4

EC Name:

Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Cas Number:

6386-38-5

Molecular formula:

C18H28O3

IUPAC Name:

methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nicholas Helf
- Age at study initiation: 8 weeks
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: 1 animal/cage in suspended wire mesh cages
- Diet: Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: 1 week

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 200 cm squared
- % coverage: 10%
- Type of wrap if used: Gauze patches, secured with adhesive tape and wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities

Clinical signs:

other: Slight erythema was noted at 25 hours. Day 7 and 14, Slight edema was noted at 25 hours.

Gross pathology:

Necropsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The LD 50 in rabbits after dermal application of the test substance is greater than 2.0 g/kg of body weight.

Executive summary:

In an acute dermal toxicity test 2 male and 2 female New Zealand white rabbits were dosed with 2000 mg/kg of the test substance. 24 hours prior to dosing the fur was clipped from the backs of the animals. Just prior to dosing, abrasions were made in one half of the.rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding. The test material was applied to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. The exposure site was washed with warm tap water and dermal reactions were scored at 25 hours, 7 and 14 days by the Draize score. No mortalities occured. Slight erythema was noted at 25 hours, day 7 and 14, slight edema was noted at 25 hours. Two animals lost weight and two animals body weights were normal. Necropsy findings were normal. In conclusion, the dermal LD 50 after single application to rabbit skin is greater than 2000 mg/kg.