Registration Dossier

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
Reference
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 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:
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
intact 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
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
Interpretation of results:
corrosive
Remarks:
Migrated information
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
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:
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)
24 hours: cornea, iris, conjunctivae: 84.7/110 (mean score)
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
Interpretation of results:
highly irritating
Remarks:
Migrated information
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.

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.

Under R67/548/EEC (29. ATP) p-cresol and m-cresol as well as o-cresol are classified as corrosive: R 34 = causes burns

According to Regualtion (EC) No. 1272/2008 the substance is allocated to Category 1B of skin corrosive substances; Hazard Communication H314.