Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In accordance with the CLP criteria, skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”.

Tributyl phosphateis a known skin irritant.No sensitisation effects of tributyl phosphate were reported in experimental systems as well as in human patch test studies (OECD SIDS, 2002).

In conclusion, based on the skin sensitization data summarized here, tributyl phosphate is not considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:

In accordance with the CLP criteria, respiratory sensitizer is defined as “a substance that will lead to hypersensitivity of the airways following inhalation of the substance”. Generally, a substance is classified as respiratory sensitizer if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or if there are positive results from an appropriate animal test.

Currently, no recognized animal models for the testing of respiratory hypersensitivity are available.

Therefore, evidence that a substance can induce specific respiratory hypersensitivity will normally be based on human experience. However, no hypersensitivity reactions associated with exposure totributyl phosphatewere reported in humans.

In conclusion, based on the respiratory sensitization data summarized here and taking into account that there have been no reports of respiratory sensitization caused bytributyl phosphate, it is not considered to be a respiratory sensitizer.

Justification for classification or non-classification