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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June to 03 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 without any deviation
- Justification for type of information:
- An in vivo study was performed for worldwide (Asia) notification purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2010-12-07 / Signed on 2011-03-07
Test material
- Reference substance name:
- (2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one
- Molecular formula:
- C16 H26 O
- IUPAC Name:
- (2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one
- Reference substance name:
- (2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one
- Molecular formula:
- C16 H26 O
- IUPAC Name:
- (2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: white crystals
- 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: 2.21-3.12 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: between ten and fifteen changes per hour.
- Photoperiod: 12 hours light/12 hours dark.
IN-LIFE DATES: From 12 June to 03 July 2012.
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 g
- 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 females
- 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: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
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:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- 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
- Irritation parameter:
- edema score
- Basis:
- animal #2
- 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
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- - A well defined erythema was noted on the treated area of all animals, 1 hour after the patch removal. The erythematous reactions were totally reversible between days 1 and 7.
- A slight to moderate oedema was noted on the treated area of all animals, 1 hour after the patch removal.
- The oedematous reactions were totally reversible between days 1 and 7. Dryness was noted on day 3 in all animals and was totally reversible between days 7 and 14. - 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 |
||
A2136/Female |
A2164/Female |
A2166/Female |
||
Erythema/Eschar formation |
1 h |
2 |
2 |
2 |
24 h |
2 |
0 |
2 |
|
48 h |
2 |
0 |
1 |
|
72 h |
1 |
0 |
1 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
5 |
0 |
4 |
|
Mean (24, 48 and 72 hours) |
1.7 |
0 |
1.3 |
|
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 |
||
A2136/Female |
A2164/Female |
A2166/Female |
||
Oedema formation |
1 h |
3 |
2 |
3 |
24 h |
3 |
0 |
1 |
|
48 h |
2 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
6 |
0 |
1 |
|
Mean (24, 48 and 72 hours) |
2 |
0 |
0.3 |
|
Note:
A2136: dryness from D3 to D7
A2164: dryness at D3
A2166: dryness from D3 to D7
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 Regulation EC No. 1272/2008 (CLP) and 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 g of undiluted test item was applied on an undamaged skin area of the flank of 3 female 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.
As well defined erythema was noted on the treated area of all animals, 1 hour after the patch removal. The erythematous reactions were totally reversible between days 1 and 7. A slight to moderate oedema was noted on the treated area of all animals, 1 hour after the patch removal. The oedematous reactions were totally reversible between days 1 and 7. Dryness was noted on day 3 in all animals and was totally reversible between days 7 and 14.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.7 / 0.0 / 1.3 for erythema and 2.0 / 0.0 / 0.3 for oedema. These effects are reversible between days 2 and 7.
Therefore, the test material is not classified as irritant to the skin according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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