Registration Dossier

Administrative data

Description of key information

Most critical cresols:
skin irritation: corrosive (o-cresol)
eye irritation: corrosive (o-cresol)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

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

The most critical component of the cresols was with the o-cresol which was corrosive to the skin and the eye of rabbits.

Skin irritation:

0.5 mL undiluted o-cresol was applied to the intact and abraded skin of 6 rabbits and readings were made 24, 48 and 72 hours after application. o-cresol 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). A study with m-cresol was performed where 0.5 mL of the undiluted test substance was applied to the intact and to the abraded skin of 6 rabbits (Ind. Bio-test Lab Inc 1969). At the observation time of 24 hours after application all animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) that persisted to the second observation time point after 72 hours. No tissue destruction and /or necrosis had been reported. In another study, application of 0.5 ml undiluted p-cresol on shaved intact or abraded rabbit skin areas, coverage not mentioned, and reading up to 72 hours post application yielded in a mean irritation score of 8 of max 8 respectively and reversibility was not reported (Ind Bio-test Lab Inc 1969).

 

Eye irritation:

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). Based on the results in these studies o-cresol is evaluated as corrosive. Application of 0.5 ml of m-cresol or 0.1 ml p-cresol into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score of 87.3 and 89 respectively of max 110 accounting for severe irritancy. Reversibility was not reported (Ind Bio-test Lab Inc 1969).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Because of the missing data for the exposure time cresols have to be classified according to:

DSD: C, R34: Causes burns;

CLP: Category 1B, H314: Causes severe skin burns and eye damage