Registration Dossier
Registration Dossier
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EC number: 214-780-7 | CAS number: 1193-81-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability has been presented as 2 because a protocol similar to OECD Guideline has been followed but pre-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-cyclohexylethanol
- EC Number:
- 214-780-7
- EC Name:
- 1-cyclohexylethanol
- Cas Number:
- 1193-81-3
- Molecular formula:
- C8H16O
- IUPAC Name:
- 1-cyclohexylethanol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No further info on test animals or environmental conditions were provided.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- OBSERVATION TIME POINTS: Erythema and edema after 4, 24, 48 and 72 hours and 7 days.
- Method of calculation: final irritation score was calculated as the average of iritation scores at 24 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #5
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #3
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #5
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- animal #6
- Irritant / corrosive response data:
- - Individual erythema scores for each animal were 2, 4, 3 and 3 for t=4, 24, 48 and 72 hours respectively.
- Individual edema scores for animal #1 were 2, 4, 3 and 3 for t=4, 24, 48 and 72 hours respectively. Individual edema scores for animal #2, #3, #4, #5 and #6 were 2, 3, 3 and 3 for t=4, 24, 48 and 72 hours respectively.
- All adverse effects were fully reversible within 7 days. - Other effects:
- - A defatting effect was observed: skin sloughed off in ten to fourteen days. There was no in depth injury.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant Category 2
- Remarks:
- according to Regulation (EC) No 1272/2008 and its amendments.
- Conclusions:
- The substance was tested in a skin irritation study. Based on the results, the substance is considered to be a skin irritant.
- Executive summary:
The substance was tested in a skin irritation study, equivalent to OECD TG 404. Six rabbits were exposed to the substance for 24 hours (instead of the normal 4h). Individual erythema scores for each animal were 4, 3 and 3 for t= 24, 48 and 72 hours respectively. Individual edema scores for animal #1 were 4, 3 and 3 for t=24, 48 and 72 hours respectively, and individual edema scores for animal #2, #3, #4, #5 and #6 were 3, 3 and 3 for t=24, 48 and 72 hours respectively. This resulted in a mean erythema score of 3.3 in all animals and a mean edema score of 3.3 and 3 for animal #1 and animals #2, #3, #4, #5 and #6 respectively (average of scores at 24, 48 and 72 hours). These effects had fully reversed within 7 days. A defatting effect was observed: skin sloughed off in ten to fourteen days, and no in depth injuries were observed. Based on these results, the substance is considered to be a skin irritant.
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