Registration Dossier
Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
Endpoint summary
Administrative data
Description of key information
Overall, based on the results in the skin and eye irritation studies p-cresol is evaluated as corrosive.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no further data
- 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
- 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no information on GLP, strain used
- Principles of method if other than guideline:
- 0.1 ml undiluted test substance was applied into the eye of rabbits, time of reading: 24, 48, 72 hrs.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- no further data
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 63.3
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Score:
- 15.7
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- other: mean score cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 72 hours
- Score:
- ca. 93
- Max. score:
- 110
- Irritation parameter:
- other: mean score cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 48 hours
- Score:
- ca. 89.7
- Max. score:
- 110
- Irritation parameter:
- other: mean score: cornea, iris conjunctivae
- Basis:
- animal: mean score for all animals
- Time point:
- other: 24 hours
- Score:
- ca. 84.7
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal: all animals
- Time point:
- other: up to 72 hours
- Score:
- ca. 89
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: (mean over total observation period)
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
The application of 0.1 ml undiluted p-cresol into the eyes of rabbits followed by an obervation period of upto 72 hours resulted in mean irritation score 89 of max 110. Reversibility is not reported.
Reference
mean score for cornea: 60; mean score for iris: 10; mean score for conjunctivae: 14.7 48 hours: cornea, iris, conjunctivae: 89.7/110 (mean score)
mean score for cornea: 63.3, mean score for iris: 10, mean score for conjunctivae: 16.3 72 hours: cornea, iris, conjunctivae: 93.0/110 (mean score)
mean score for cornea: 66.6, mean score for iris: 10; mean score for conjunctivae: 16.3 summary: irritation score: 89.0/110
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
IRRITATION TO SKIN
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 (Ind Bio-test Lab Inc 1969). Application of p-cresol to the clipped back of rabbits for 4 hours under semi-occlusive conditions resulted in visible tissue damage indicative of corrosive effects (Vernot 1977).
IRRITATION TO EYE
The application of 0.1 ml undiluted p-cresol into the eyes of rabbits followed by an obervation period of upto 72 hours resulted in mean irritation score of 89 of max 110. Reversibility is not reported (Ind Bio-test Lab Inc 1969).
Overall, based on the results in these studies p-cresol is evaluated as corrosive
Justification for selection of skin irritation / corrosion endpoint:
The most reliable study was used as key study and for classification.
Justification for selection of eye irritation endpoint:
The most reliable study was used as key study and for classification.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Overall, based on the results in the skin and eye irritation studies p-cresol is evaluated as corrosive.
According to Regualtion (EC) No. 1272/2008 the substance is allocated to Category 1B of skin corrosive substances; Hazard Communication H314.
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