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Registration Dossier
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EC number: 288-284-4 | CAS number: 85711-26-8
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C9-11-branched and linear
- EC Number:
- 288-284-4
- EC Name:
- Alcohols, C9-11-branched and linear
- Cas Number:
- 85711-26-8
- Molecular formula:
- C9H20O, C10H22O and C11H24O
- IUPAC Name:
- Alcohols, C9-11-branched and linear
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Institute, New Jersey, USA
- Age at study initiation:
- Weight at study initiation: 2.2 - 3 kg
- Housing: individual, suspended, stainless steel cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24 and 48 hours after exposure and at 7 days.
- Number of animals:
- 3M, 3F
- Details on study design:
- TEST SITE
- Type of wrap if used: gauze patches were held in place with strips of Blenderm tape. The entire trunk was then covered in plastic covering, which was secured and sealed and then wrapped with elastic bandage to immobilize and occlude the patches.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was wiped away with a moist towel.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.46
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- skin reactions were assessed at 24/72h
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: Mean 24 + 72 hour score for 6 animals intact skin 2.67, abraded skin 2.75.
- Oedema: Mean 24 + 72 hour score for 6 animals intact skin 1.46, abraded skin 1.54.
-PDII 4.2
REVERSIBILITY: At 7 days all the application sites had developed eschar (scored as 4) so the effects had increased over the period of the study.
PII 4.2.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The in vivo skin irritation study for Alcohols, C9-11-branched and linear, conducted according to a protocol similar to OECD Test Guideline 404 and in compliance with GLP, concluded Alcohols, C9-11-branched and linear to be irritating to skin.
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