(1α,2β,4β,6α)-2,2,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD 404 and under GLP. No information on the composition of the test item is available. Individual animal weights at start and conclusion of test not reported.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[1R-(1α,2β,4β,6α)]-2,2,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane

EC Number:

243-411-2

EC Name:

[1R-(1α,2β,4β,6α)]-2,2,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane

Cas Number:

19894-99-6

Molecular formula:

C10H16O

IUPAC Name:

(1R,2R,4S,6R)-2,7,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane

Details on test material:

Name: EPOXY ALPHA PINENE GAUCHE
Appearance: colourless liquid
Storage conditions: room temperature, protected from light and heat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: JEGARD, 22120 Yffiniac, France
- Housing: individual housing on floor grid.
- Diet: complete pelleted rabbit maintenance diet ERGILAP
- Acclimation period: at least 5 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item was applied

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: clipped skin from the dorsal area of the trunk
- Type of wrap used: Undiluted test item was applied to the clipped skin then covered with a gauze (2.5 x 2.5 cm) held in place by means of a 5 x 5 cm wide "Micropore" fastening tape. Then the trunk of the animals was wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, placed in such way so as not to hinder respiratory movements.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
- Residual test substance was removed using coton wool moistened with water.

SCORING SYSTEM: According to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 72h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 72h

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item is classified as "R38: irritating to skin" according to the Directive 67/548/EEC and Category 2 "H315 Cause skin reaction" to the CLP Regulation (EC) N° 1272 /2008.

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand albino rabbits were dermally exposed to 0.5 mL of undiluted EPOXY ALPHA PINENE GAUCHE under a semi-occlusive patch for 4 h on clipped skin. After removal of the dressings, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h after exposure.

The application of the test item produced one hour after patch removal, in all animals, the outbreak of well defined erythema with slight to moderate edema. During the first 72 hours, erythematous reactions were maintained or decreased in the rabbits and the oedematous reactions decreased in all the rabbits. The reversibility of this cutaneous reactions was complete within 8 days for one rabbit and 9 days for the 2 others.

Mean scores over 24, 48 and 72 h for each animal were 2.0, 1.3 and 2.0 for erythema and 2.3, 1.3 and 2.3 for edema.

Under the test conditions, the test item was classified as "R38: irritating to skin" according to the Directive 67/548/EEC and Category 2 "H315 Cause skin reaction" to the CLP Regulation (EC) N° 1272 /2008.