Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Skin sensitisation:

In accordance with the CLP criteria, skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. To be classified as a skin sensitiser (Category 1) there must be evidence of chemicals’s sensitizing effects observed in substantial number of people.

 

No data on skin sensitisation potential ofMineral Paraffin Oilin humans were located. In addition, no alerts for sensitising properties ofMineral Paraffin Oil components were identified with the applicable QSAR models.

 

Based on the data summarized here and taking into account that there have been no reports of skin sensitization caused byMineral Paraffin Oil, it is not considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Respiratory sensitisation:

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 toMineral Paraffin Oilwere reported in humans. Therefore,Mineral Paraffin Oilis not considered to be a respiratory sensitizer.

Justification for classification or non-classification