Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Of the two studies available on xylenols, 3,5 xylenol returned an equivocal result. Whilst the author of this study concluded that the test material, 3,5 xylenol did not exhibit any skin sensitising potential, due to similar skin reactions being elicited by the solvent and the test preparation, the outcome of the study could not be concluded with confidence. The study conducted on 2,4 xyelnol returned a positve result, furthermore, no reactivity with the solvent was observed.

 

Both the Draize test and the human maximisation test on p-cresol confirmed this cresol isomer to be a non-sensitiser. The GPMT on o-cresol did not provide sufficient information to allow a definitive conclusion to be drawn.

 

Currently no skin sensitisation data is available for ethyl phenols; based on structural similarities a conservative approach who be to conclude that ethyl phenols will give a similar effect to that observed by 2,4 xylenol, Skin Sensitiser.

 

The overall conclusion for this endpoint who be that of a potential skin sensitiser.


Migrated from Short description of key information:
Skin Sensitisation:
Key study on 2,4 xylenol (GPMT). Weimann, 1999. KL.1 - Sensitiser
Disregarded study on 3,5 xylenol (GPMT). Weimann, 1999. KL.3 - No conclusion drawn due to cross reaction in vehicle animals
Supporting study on p-cresol (Draize). Sharp, 1978 - Non-sensitiser.
Supporting study on p-cresol (human MT). Opdyke, 1974. KL.2 - Non sensitiser
Disregarded study on o-cresol (GPMT). Bruze, 1986. KL.4 - Insufficient information to draw a conclusion.

Respiratory Sensitisation:
Currently no validated in vivo methods available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Respiratory sensitisation

Currently no validated in vivo methods are available. Neither xylenols, cresols or ethylphenols contain reactive chemical groups which are known respiratory sensitisers. Consequently there is no concern regarding this endpoint.


Migrated from Short description of key information:
N/A

Justification for classification or non-classification