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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Application of 0.5 ml undiluted substance on shaved intact or abraded rabbit skin areas, coverage not mentioned, and reading up to 72 hours post application yielded mean irritation score 8 of max 8. Reversibility is not reported. Using semi-occlusive dressing for 4 hours, the visible tissue damage caused by m-cresol was indicative of corrosive effects (no scores given, Vernot 1977).
Application of 0.5 ml into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score 87.3 of max 110 accounting for severe irritancy. Reversibility is not reported (Ind Bio-test Lab Inc 1969).

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: limited documentation; no information on exposure time and conditions
Principles of method if other than guideline:
0.5 ml undiluted TS was applied to the intact and to the abraded skin, time of observation: 24 and 72 hours
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Preparation of test site:
other: partly shaved intact skin, partly shaved and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
no data undiluted
Observation period:
up to 72 hours
Number of animals:
6
Details on study design:
evaluation of erythema and edema
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 8
Max. score:
8
Reversibility:
not reversible
Remarks on result:
other: All animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) from the first observtion time point being reported (24h).
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: All animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) from the first observtion time point being reported (24h).
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: All animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) from the first observtion time point being reported (24h).
Irritant / corrosive response data:
All animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) from the first observtion time point being reported (24h).
Other effects:
no data

Intact skin, erythema. edema: 24 hr: Score 4 in 6/6; 72 hr: Score 4 in 6/6.
Abraded skin, erythema, edema: 24 hr: Score 4 in 6/6; 72 hr: Score 4 in 6/6.
No tissue destruction and/or necrosis reported, no further details reported.
Summary: 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 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: observation time should be longer to evaluate reversibility
Principles of method if other than guideline:
0.1 ml undiluted testsubstance was applied into the eye of rabbits, time of reading: 24, 48 and 72 hours.
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 data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: score cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 24 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
other: see time point: 48 hours
Irritation parameter:
other: mean score: cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 48 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
other: see time point: 72 hours
Irritation parameter:
other: mean score: cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 72 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
not specified
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: 87.3/110
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:
From beginning of the observation all animals showed irritational effects in the cornea (score 60), iris (score 10) and concunctivae (score 16-18) of the eye which did not change during the observation period of 72 hours.
Other effects:
no data

after 24 hrs: cornea, iris, conjunctivae: 87.3 (mean score): -- mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
after 48 hrs: cornea, iris, conjunctivae: 87.3 (mean score):
-- mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
after 72 hrs: cornea, iris, conjunctivae: 87.3 (mean score)
--mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
summary: irritation score: 87.3/110

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

Application of 0.1 ml into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score 87.3 of max 110. Reversibility was not reported.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

IRRITATION TO SKIN

Application of 0.5 ml undiluted substance on shaved intact or abraded rabbit skin areas, coverage not mentioned, and reading up to 72 hours post application yielded mean irritation score 8 of max 8. Reversibility is not reported. Using semi-occlusive dressing for 4 hours, the visible tissue damage caused by m-cresol was indicative of corrosive effects (no scores given, Vernot 1977).

IRRITATION TO EYE

Application of 0.5 ml into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score 87.3 of max 110 accounting for severe irritancy. Reversibility is not reported (Ind Bio-test Lab Inc 1969).

OVERALL

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


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Overall, based on the results on skin and eye irritation m-cresol is evaluated as corrosive.

According to Regulation (EC) No 1272/2008 the substance is allocated to category 1B of skin corrosive substances, Hazard Communication H314.