Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate

EC Number:

244-435-6

EC Name:

Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate

Cas Number:

21544-03-6

Molecular formula:

C14H18O6

IUPAC Name:

1,2-bis[(oxiran-2-yl)methyl] cyclohex-4-ene-1,2-dicarboxylate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

The test was performed on 3 male and 3 female rabbits of the Himalayan breed weighing 1.5 to 2 kg.
They were housed individually in metal cages, were kept at a constant room temperature of 22 + 1 C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day.
The animals received ad libitum Standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: 2 days before treatment: shaved and immediately before treatment the left side was slightly scarified.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL.

Duration of treatment / exposure:

24 hours exposure time.

Observation period:

72 hours

Number of animals:

3 male and 3 female

Details on study design:

Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly scarified. For treatment gauze patches of 2.5 x 2.5 cm with test material were applied to the prepared abraded and non abraded skin, in quantities of 0.5 ml.

The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.
The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after
initiation of treatment). Skin irritation was scored in accordance with the irritation score according to the scoring system available below.

The severity of skin irritation was rated as follows:
A mean value of less than 2 indicated mild, from 2 to 6 moderate and above 6 severe skin irritation.

SCORING SYSTEM:

Score for skin irritation in rabbits
Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Maximum possible erythema score: 4

Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4

Maximum possible edema score 4

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

The primary irritation index is the mean value of the sum of the scores for erythema and edema from all 6 rabbits 24 and 72 hours after initiation of treatment. The maximum possible score is 8.

Time point:

other: 24-72 hours

Score:

3

Max. score:

8

Reversibility:

not fully reversible within: 3 days

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

The primary skin irritation index in this experiment was established to be 3.0. The test material caused therefore a moderate skin irritation to rabbits.

Any other information on results incl. tables

Skin irritation in individual rabbits

		24 hours after application		72 hours after application
Animal N° sex	Skin reaction	Intact skin	Scarified skin	Intact skin	Scarified skin
1 male	Erythema	0	2	0	2
1 male	Edema	0	2	0	1
2 male	Erythema	2	3	3	3
2 male	Edema	2	2	2	1
3 male	Erythema	0	2	2	3
3 female	Edema	2	2	0	1
4 female	Erythema	0	2	2	2
4 female	Edema	2	2	0	0
5 female	Erythema	0	3	2	3
5 female	Edema	1	3	0	1
6 female	Erythema	2	2	3	3
6 female	Edema	1	2	0	0

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The primary irritation index, a measure of the acute irritation to the rabbit skin was 3.0. This indicates that the test material is a moderate irritant to the rabbit skin.

Executive summary:

The skin irritation potential of the test item was determined according to the procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

The test was performed on 3 male and 3 female rabbits of the Himalayan breed.

Two days before treatment the entire back and the flank of the rabbits were shaved and immediately before treatment the shaven skin on the left side was slightly scarified.

For treatment the test material was applied to the prepared abraded and non abraded skin, in quantities of 0.5 ml.

The patches were covered with an impermeable material (occlusive application) for 24 hours.

The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment).

The primary skin irritation index in this experiment was established to be 3.0. The test material caused therefore a moderate skin irritation to rabbits.