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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP, but well reported. Testing procedure more stringent than OECD testing guideline 404.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The Draize test was used to assess primary skin irritation. Six rabbits were used. The back of each rabbit was clipped free of hair 24 h before application of the mixture. Four sites, two intact and two abraded, were established. The material was applied at each location. The test sites were covered with a gauze pad and the entire back was overlaid with an adhesive plastic surgical drape. Each rabbit was then placed in a rabbit jacket. The jackets and wraps were removed 24 h later, and each test site was scored visually for erythema and edema. Readings were recorded at 24, 48, and 72 h. A final irritation score was calculated for the 24- and 72-h readings.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

229-722-6

EC Name:

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

Cas Number:

6683-19-8

Molecular formula:

C73H108O12

IUPAC Name:

3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Specific details on test material used for the study:

- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Keen Ridge Rabbit Ranch, Edgewood, New Mexico
- Weight at study initiation: 2.0 - 3.0 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: corn oil

Controls:

no

Amount / concentration applied:

500 mg substance in 0.5 mL of corn oil

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Back
- Type of wrap if used: The test sites were covered with a gauze pad, and the entire back was overlaid with an adhesive plastic surgical
drape.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

None of the 6 rabbits exhibited edema or erythema in 24 h; therefore, all animals were judged normal. The total primary irritation score was 0.00.