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EC number: 456-350-3 | CAS number: 878665-13-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 May 2004 to 28 May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 and in compliance with GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- 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:
- UK GLP Compliance Programme (inspected on 2002-12-02)
Test material
- Reference substance name:
- (3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Reference substance name:
- (3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Molecular formula:
- C25 H46 O S
- IUPAC Name:
- (3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
- Test material form:
- liquid
- Details on test material:
- - Physical state: white solid or Colourless liquid (depending on temperature)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- - Stability under test conditions: stable
- Storage condition of test material: ca. 4°C in the dark under nitrogen
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): free access
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 To: 28 May 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE (moistened with water)
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze patch secured on position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (gentle swabbing with cotton wool soaked in distilled water)
- Time after start of exposure: 4 hours
SCORING SYSTEM: draize scale, as described in OECD Test Guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema was noted at all treated skin sites one hour after patch removal. Reversibility of any observed effect: Changes fully reversible within 1 day
- Other effects:
- None
Any other information on results incl. tables
Very slight erythema was noted at all treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 24 -hour observation.
Table 7.3.1: Individual Daily and Mean Scores for Dermal Irritation Following a 4-hour exposure
|
|
Individual Scores – Rabbit Number and sex |
||
Skinreaction |
Reading (hours) |
1 male |
2 male |
3 male |
Erythema/escharFormation |
1 24 48 72 |
1 0 0 0 |
1 0 0 0 |
1 0 0 0 |
Mean Score (24 -48 -72 h) |
0.0 |
0.0 |
0.0 |
|
Oedema Formation |
1 24 48 72 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Mean Score (24 -48 -72 h) |
0.0 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and 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 test material moistened with water was dermally applied on the clipped skin of the dorsal surface of 3 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.
Slight erythema was observed 1 hour following patch removal. The individual scores calculated over all the animals tested within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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