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EC number: 225-392-2 | CAS number: 4819-67-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 14 to 17, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed according to US-FHSA guideline. Deviations from standard method: no data on test animals, 24 h exposure instead of 4h, occlusive dressing instead of semi-occlusive, observation at 24 and 72 h only (no 48h scoring), reversibility not assessed during a 14-day observation period. However, since only minimal responses persisted until the 72-h time point (maximum score = 1), the study results can be used for classification purpose (Ref: CLP Guidance). A repeat study is unlikely to show worse effects; therefore, this study was considered sufficiently robust to cover this endpoint.
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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.41 - Hazardous Substances and articles, administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
Test material
- Reference substance name:
- 2-pentylcyclopentan-1-one
- EC Number:
- 225-392-2
- EC Name:
- 2-pentylcyclopentan-1-one
- Cas Number:
- 4819-67-4
- Molecular formula:
- C10H18O
- IUPAC Name:
- 2-pentylcyclopentan-1-one
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): P1078/2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one side intact, the other side abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g on each site - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Side of the animals
- Type of wrap if used: Treated areas were covered with gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #4 & #6
- Time point:
- other: mean 24 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #4, #5 & #6
- Time point:
- other: mean 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- - Slight erythema and oedema were observed.
- Other effects:
- No data
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test (intact skin)
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
24 h |
1 / 1 / 0/ 1 / 0 / 1 |
1 / 0 / 0/ 1 / 1 / 1 |
72 h |
0 / 1 / 1/ 1 / 0 / 1 |
0 / 1 / 0 / 0 / 0 / 0 |
Average 24h, 72h |
0.5 / 1 / 0.5 / 1 / 0 / 1 |
0.5 / 0.5 / 0 / 0.5 /0.5 / 0.5 |
Reversibility*) |
nc. |
Nc. |
Average time for reversion |
- |
- |
Table 7.3.1/2: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test (abraded skin)
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
24 h |
1 / 1 / 0/ 1 / 1 / 1 |
1 / 0 / 0/ 1 / 0 / 1 |
72 h |
0 / 1 / 1/ 1 / 0 / 1 |
0 / 1 / 0 / 0 / 0 / 0 |
Average 24h, 72h |
0.5 / 1 / 0.5 / 1 / 0.5 / 1 |
0.5 / 0.5 / 0 / 0.5 /0 / 0.5 |
Reversibility*) |
nc. |
Nc. |
Average time for reversion |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008.
- Executive summary:
In a dermal irritation study performed according to US-FHSA guideline, 0.5 g of undiluted test material was dermally applied on the intact or abraded side surface of 6 albino rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.
Under the test conditions, the test material induced slight erythema and oedema. Although reversibility was not assessed, responses were minimal at the 72 -hour time points. According to the CLP Guidance, it is therefore possible to use this study for classification by calculating the mean values for erythema and oedema on the basis of 24 and 72 -h time points.
The individual scores for each animal within 3 scoring times (24, 48 and 72 hours) were 0.5 / 1 / 0.5 / 1 / 0 / 1 for erythema and 0.5 / 0.5 / 0 / 0.5 /0.5 / 0.5 for oedema).
Therefore, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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