Registration Dossier
Registration Dossier
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EC number: 204-017-6 | CAS number: 112-92-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996/03/13-1996/03/16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- CH3(CH2)17OH
- IUPAC Name:
- octadecan-1-ol
- Test material form:
- solid
Constituent 1
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: 12 to 16 weeks
- Weight at study initiation: 2.56 to 2.73 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)
- Water: Tap water (ad libitum)
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19C
- Humidity (%): 49-60%
- Air changes: 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: Not stated.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of fur
- Vehicle:
- other: 0.5 g test material moistened with 0.5 ml water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of test material, moistened with 0.5ml of distilled water - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1h, 24h, 48h, 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: The back of the rabbit
- % coverage: 2.5x2.5cm patch
- Type of wrap if used: A cotton gauze patch was secured in position with surgical adhesive tape (BLENDERM) approximate size 2.5x4.0cm. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patches were removed and any residual test material removed by gentle swabbing with cotton.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize J H 1977 "Dermal and Eye Toxicity Tests"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No corrosive effects were noted.
- 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:
- The test material produced a primary irritation index of 0.0. No evidence of skin irritation was noted during the study, all scores were 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following a 4 hour semi-occlusive exposure to rabbits skin Kalcol 8098 was non-irritating to rabbit skin.
- Executive summary:
In a skin irritation study, 0.5 g test material moistened with 0.5 ml water was applied onto the skin of 3 rabbits and kept in contact to the skin under semi-occlusive dressing for 4 hours. The primary dermal iritation index was scored at 1, 24, 48 and 72 hours post-appliaction.
The test material produced a primary irritation index of 0.0. No evidence of skin irritation was noted during the study, all scores were 0.
The study was conducted according the appropriate OECD test guideline and in compliance with GLP.
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