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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

There is no study according to the current OECD test guideline but the studies, which were choses as key studies, are adequately documented and are considered of sufficient quality to allow an evaluation of this endpoint. Based on the results in these studies o-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: sufficient information for evaluation
Principles of method if other than guideline:
Application of the undiluted substance on shaved intact or abraded skin areas, coverage not mentioned, reading 24,48, 72 hours.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no further information
Type of coverage:
not specified
Preparation of test site:
other: shaved : intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
no data
Observation period:
72 hours
Number of animals:
6
Details on study design:
Evaluation of erythema and edema.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
other: mean value overall animals
Time point:
other: abraded and intacxt skin: after 72 hours
Score:
ca. 8
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
no further information
Other effects:
no further information

intact and abraded skin:
total irritation score: 8.00/8.00

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Executive summary:

Application of 0.5 ml undiluted substance on shaved intact or abraded rabbit skin areas, coverage not mentioned, and reading 24, 48, 72 hours post application yielded mean irritation score: 8 of max 8. Reversibility is not reported (Industrial Biotest Laboratories 1969).

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: sufficient information to evaluate the substance
Principles of method if other than guideline:
Application of 0.1 ml of the undiluted substance into the eye of each of 6 rabbits reading 24hrs, 48 hrs and 72 hours: cornea, iris, conjunctivae.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no further information
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:
no data
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: no data
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 91.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
48 h
Score:
ca. 86.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 82.7
Max. score:
110
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after 72 hour reading
Score:
ca. 91.3
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for edema score avaiable. Total irritation score: 91.3/110
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for iris score avaiable. Total irritation score: 91.3/110
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for conjunctivae score avaiable. Total irritation score: 91.3/110
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for chemosis score avaiable. Total irritation score: 91.3/110
Irritant / corrosive response data:
no further data
Other effects:
none reported

Total irritation score: 91.3/110.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

Application of 0.1 ml undiluted testsubstance into the eyes of rabbits and observation for up to 72 hours resutlted into a mean score of 97 of max 110. Reversibility is not reported (Industrial Biotest Laboratories 1969).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is no study according to the current OECD test guideline but the studies, which were choses as key studies, are adequately documented and are considered of sufficient quality to allow an evaluation of this endpoint.

SKIN

Undiluted o-cresol was applied to the intact and abraded skin of rabbits (no further experimental details given) and caused within 24 hours severe erythema and edema in each rabbit (mean score 8.00 of 8.00 [max], Ind. Bio-test Lab Inc 1969). In another study, application of o-cresol for 4 hours under semiocclusive conditions yielded severe edema and necrosis within 24 hours and eschar formation within 14 days (no scores given, Ferro Corp 1978).

EYE

Application of o-cresol into the conjunctival sac of the rabbits eyes resulted in severe irritation (mean score: 91.3 of 110[max]). Recovery was not reported (Ind. Bio-test Lab Inc 1969).

OVERALL

Based on the results in these studies o-cresol is evaluated as corrosive.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Under Harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) - m-and p-cresol as well as o-cresol are classified as corrosive Skin Corr. 1B;  H314.