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EC number: 474-190-2 | CAS number: 875471-31-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 08 and 20 November, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 with deviations not affecting the reliability of the study: details on feeding and environmental conditions not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-07-01 / Signed on 2004-09-13.
Test material
- Reference substance name:
- (5R)-5-pentyloxan-2-one
- Molecular formula:
- C10 H18 O2
- IUPAC Name:
- (5R)-5-pentyloxan-2-one
- Reference substance name:
- (5S)-5-pentyloxan-2-one
- Molecular formula:
- C10 H18 O2
- IUPAC Name:
- (5S)-5-pentyloxan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: room temperature.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe).
- Weight at study initiation: 2.74 - 3.46 kg.
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: no data
- Water: no data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-22 °C
- Humidity: 30-58 %
- Air changes: no data
- Photoperiod: no data
IN-LIFE DATES: From 08 to 20 November, 2005.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
- Number of animals:
- 3 males
- Details on study design:
- PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: Undamaged skin area of the right flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: no data.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable.
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - A slight to important erythema in the 3 animals, associated with a slight oedema in two animals, was noted 24 hours after the test item application.
- The oedematous reactions were totally reversible the 3rd day of the test and the erythematous reactions were totally reversible between the 4th and the 5th day of the test.
- On the cutaneous structure, the skin recovered a normal aspect, between the 5th and the 12th day of the test. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A6977/male |
A6981/male |
A6982/male |
||
Erythema/Eschar formation |
1 h |
2 |
2 |
1 |
24 h |
3 |
2 |
1 |
|
48 h |
2 |
2 |
1 |
|
72 h |
2 |
1 |
0 |
|
Day 4 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
7 |
5 |
2 |
|
Mean (24, 48 and 72 hours) |
2.3 |
1.7 |
0.7 |
|
Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A6977/male |
A6981/male |
A6982/male |
||
Oedema formation |
1 h |
1 |
0 |
0 |
24 h |
1 |
1 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
1 |
1 |
0 |
|
Mean (24, 48 and 72 hours) |
0.3 |
0.3 |
0 |
|
Note:
A6977: slight dryness from D2 to D3 and from D9 to D10, dryness from D4 to D8
A6981: slight dryness at D2, dryness from D3 to D4
A6982: slight dryness from D2 to D3
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item was applied on an undamaged skin area of the flank of 3 male New Zealand White rabbits. On the other flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
A slight to important erythema in the 3 animals, associated with a slight oedema in two animals was noted 24 hours after the test item application. The oedematous reactions were totally reversible the 3rd day of the test and the erythematous reactions were totally reversible between the 4th and the 5th day of the test. On the cutaneous structure, the skin recovered a normal aspect, between the 5th and the 12th day of the test.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.3 / 1.7 / 0.7 for erythema and 0.3 / 0.3 / 0.0 for oedema.
Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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