Registration Dossier
Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: documentation incomplete; no information on exposure time
Data source
Reference
- Reference Type:
- publication
- Title:
- Bio-Fax-data sheet: p-cresol
- Author:
- Industrial. Bio-Test Laboratory Inc.
- Year:
- 1 969
- Bibliographic source:
- Industrial Bio-Test Laboratory Inc, Northbrook, Ill/USA, data sheet no. 5-5/69
Materials and methods
- Principles of method if other than guideline:
- 0.5 ml undiluted test substance was applied to the intact and abraded skin, time of observation: 24 and 72 hrs.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-cresol
- EC Number:
- 203-398-6
- EC Name:
- p-cresol
- Cas Number:
- 106-44-5
- Molecular formula:
- C7H8O
- IUPAC Name:
- p-cresol
- Details on test material:
- Test substance: p-cresol, M.P.: 36°C; B.P.: 202°C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no further data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved intact skin or shaved and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml undiluted
- Duration of treatment / exposure:
- no data
- Observation period:
- up to 72 hours
- Number of animals:
- 6 rabbits intact skin and 6 rabbits abraded skin
- Details on study design:
- reading for erythema and edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal: mean score of each animal
- Time point:
- other: abraded and intact skin. after 72 hours
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal: mean score of each animal
- Time point:
- other: abraded and intact skin: after 72 hours
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean value over all animals
- Time point:
- other: abraded and intact skin: after 72 hours
- Score:
- ca. 8
- Max. score:
- 8
- Reversibility:
- no data
- Irritant / corrosive response data:
- no further data
- Other effects:
- no further data
Any other information on results incl. tables
72 hr: Score 4 in 6/6
edema: 24 hr: Score 4 in 6/6
72 hr: Score 4 in 6/6
abraded skin: erythema: 24 hr: Score 4 in 6/6
72 hr: Score 4 in 6/6
edema: 24 hr: Score 4 in 6/6
72 hr: Score 4 in 6/6
no tissue destruction and /or necrosis reported
Summary: irritation score: 8.00/8.00
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Executive summary:
Application of 0.5 ml undiluted p-cresol on shaved intact or abraded rabbit skin areas (coverage and exposure time not mentioned) and reading up to 72 hours post application yielded mean irritation score 8 of max. 8. Reversibility is not reported.
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