Registration Dossier
Registration Dossier
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EC number: 613-816-2 | CAS number: 6553-64-6
Skin irritation / corrosion
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 6,6-dimethylcyclohex-2-en-1-one
- EC Number:
- 613-816-2
- Cas Number:
- 6553-64-6
- Molecular formula:
- C8H12O
- IUPAC Name:
- 6,6-dimethylcyclohex-2-en-1-one
- Test material form:
- liquid
- Details on test material:
- Batch No.: LF 375 067
Purity: > 98%
Name of test material (as cited in study report): DIMETHYL-6,6-CYCLOHEXEN-2-ONE-1
Physical state: yellow liquid
Storage temperature: ambient temperature
Constituent 1
Test animals
- 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%
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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