Registration Dossier

Diss Factsheets

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:

A study with a structural analogue, EDTN, showed no indication that the test substance could elicit an SI >= 3 when tested up to 50%, the test substance was considered not to be a skin sensitizer. Therefore, the test substance EDTN does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact. This is supported by negative results from a study performed with PDTN although the levels tested were below the threshold for irritation. Overall, it was concluded that PDTN is not a skin sensitiser.


Migrated from Short description of key information:
Two studies were available: one GPMT with PDTN which was considered unreliable and one LLNA with EDTN, a structurally related substance (EDTN has two C molecules in its backbone, whereas PDTN has three. The four tails are identical).

Respiratory sensitisation

Endpoint conclusion
Additional information:

Because PDTN is not considered a skin sensitiser it is highly unlikely that PDTN would be a respiratory sensitiser. This is based on the fact that all known respiratory sensitisers - when tested - proved to be sensitisers in dermal sensitisation tests.

Justification for classification or non-classification

Based on the available data, PDTN does not need classification for skin or respiratory sensistisation.

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