2,2-dimethylpropane-1,3-diyl dibenzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to the guideline of today, observation time 7 days, no GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period 7 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dibenzoate

EC Number:

224-081-9

EC Name:

2,2-dimethylpropane-1,3-diyl dibenzoate

Cas Number:

4196-89-8

Molecular formula:

C19H20O4

IUPAC Name:

3-(benzoyloxy)-2,2-dimethylpropyl benzoate

Specific details on test material used for the study:

- yellowish white chunks

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2066-2380 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped and 3/6 rabbits abraded

Vehicle:

not specified

Controls:

other: the opposite site of the back

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

up to 72 hours

Number of animals:

6: 3/6 with intact skin and 3/6 with abraded skin

Details on study design:

3 male and 3 female rabbits were used for this study. The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. 500 mg of the test material was applied to the back of each rabbit and covered by semiocclusive dressing. The opposite site of the treated area served as control. Following 24 hours of application the bandages were removed and the application sites were washed with tepid water and examined for skin irritation. These examinations were repeated at 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean animals with intact skin

Time point:

other: 24 hours

Score:

ca. 0 - ca. 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 1/3 animals showed erythema score 1 of max 4 at 24 hours.

Results 2

Irritation parameter:

erythema score

Basis:

other: mean animals with intact skin

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

4

Remarks on result:

other: No rabbit with intact skin showed erythema at 72 hours.

Results 3

Irritation parameter:

edema score

Basis:

other: mean animals with intact skin

Time point:

other: 24 hours up to 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

other: N edema were observed.

Irritant / corrosive response data:

Animals with abraded skin showed erythema up to erythema score 2 at 24 hours and at 72 hours. 2/3 animals showed no erythema and 1/3 animals showed score 1 erythema. 1/3 animals with abraded skin showed edema up to 72 hours (score 1/4). 2/3 animals showed no edema.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2,2-dimethylpropane-1,3-diyl dibenzoate has to be evaluated as minimal to slightly irritating to the skin of rabbits, which does not lead to classification or labelling.

Executive summary:

3 male and 3 female rabbits were used for a skin irritation study similar to the respective OECD guideline. The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. 500 mg of the test material was applied to the back of each rabbit and covered by semiocclusive dressing. The opposite site of the treated area served as control. Following 24 hours of application the bandages were removed and the application sites were washed with tepid water and examined for skin irritation. These examinations were repeated at 72 hours.

Based on the available results the primary irritation score was calculated to be 0.6. Thus 2,2-dimethylpropane-1,3-diyl dibenzoate has to be evaluated as minimal to slightly irritating to the skin of rabbits, which does not lead to classification or labelling.