6,6-dimethylcyclohex-2-en-1-one

Endpoint summary

Description of key information

In accordance with Regulation EC No. 1272/2008, the test substance has to be classified in Category 1B. Hazard statement “H314: Causes severe skin burns and eye damage” with signal word “Danger” are required.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 February to 14 March 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study conducted in compliance with OECD 404 without any deviation and not under GLP

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Gérome, Quartier Labaste - 40260 Linxe, France
- Weight at study initiation: 2.50-2.90 kg
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23°C
- Humidity: 30-49%

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

1 hour

Observation period:

Obervation at 1, 24, 48 and 72h after the removal of the patch.

Number of animals:

In view of skin effects observed in the first animal treated, the two others were not treated.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.5

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

At 24 hours, a severe erythema and a moderate oedema were observed. They were totally reversible from Day 5 of the study.
At Day 4, a scab was observed on the treated site until the end of the observation period.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

In accordance with Regulation EC No. 1272/2008, the test substance has to be classified in Category 1B. Hazard statement “H314: Causes severe skin burns and eye damage” with signal word “Danger” are required.

Executive summary:

An in vivo skin irritation test on rabbit was conducted to predict the acute skin irritation potential of the test substance according to Guideline OECD 404.

The test substance was applied in one rabbit. 24h after the application, a severe erythema couple with a moderate edema were observed. This reactions were totally reversibles after 5 days. At day 4, the formation of a scab on the treated site was observed. This scab was noted until the end of the observation period.

Therefore, in accordance with Regulation EC No. 1272/2008, the test substance has to be classified in Category 1B “ Causes severe skin burns and eye damage”. Hazard statement “H314: Causes severe skin burns and eye damage” with signal word “Danger” are required.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

An in vivo skin irritation test on rabbit was conducted to predict the acute skin irritation potential of the test substanceaccording to Guideline OECD 404.

The test substance was applied in one rabbit. 24h after the application, a severe erythema couple with a moderate edema were observed. This reactions were totally reversibles after 5 days. At day 4, the formation of a scab on the treated site was observed. This scab was noted until the end of the observation period.

Justification for classification or non-classification

In accordance with Regulation EC No. 1272/2008, the test substance has to be classified in Category 1B. Hazard statement “H314: Causes severe skin burns and eye damage” with signal word “Danger” are required.