Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Methylparaben has been tested in three skin sensitization studies (two similar to the Guinea pig maximization test and one according to the Bühler method) to assess the sensitising potential of the test item. In one maximization study Methylparaben induced allergic reactions in 4/20 animals. According to the standard evaluation, this number is not high enough to be significant. In the second maximization test Methylparaben did not induce allergic reactions. The study according to the Bühler method did not reveal any allergic response.

 


Migrated from Short description of key information:
Methylparaben has been tested in three skin sensitization studies (two similar to the Guinea pig maximization test and one according to the Bühler method) to assess the sensitising potential of the test item.

Respiratory sensitisation

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

There are no respiratory sensitization properties of the substance known in literature. Beyond this there is no hint of any sensitization property of the compound from the conducted skin sensitization studies. Therefore, it is concluded that the subsance is not a respiratory sensitizer.


Migrated from Short description of key information:
Based on the existing data it is concluded that the substance is not a respiratory sensitizer.

Justification for classification or non-classification

Methylparaben has been tested in three skin sensitization studies (two similar to the Guinea pig maximization test and one according to the Bühler method) to assess the sensitising potential of the test item. None of them resulted in a statistically significant allergical response. Furthermore, allergic skin reactions or case reports of acute contact dermatitis to Methylparaben alone have not been described in the literature. Therefore, the substance does not have to be classified as a skin sensitizer.

A classification concerning respiratory sensitizing properties is not warranted as the classification criteria according to EU regulation 1272/2008 and 67/548 are not met.