Registration Dossier
Registration Dossier
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EC number: 203-577-9 | CAS number: 108-39-4
Endpoint summary
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
- 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
- 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.
Reference
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.
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: 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
- 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.
Reference
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
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.
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