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:
Two sensitization tests were conducted in guinea pigs using the method of Buehler. One of them gave a positive response after re-challenge whereas the other produced negative results. However, the positive response obtained is inconsistent with other information and suggestive of a technical abnormality during the study. The strong irritant effect during induction phase, only observed in this assay, is also surprising, considering the minimal evidence for irritancy in other studies. 

 

Due to conflicting information, tests were conducted in humans. No positive reactions were reported in a repeated insult patch test conducted with DINP in humans (ExxonMobil, 1995). Accordingly, it is concluded that DINP is not a sensitizer in humans and is not classified. 

Respiratory sensitisation

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

Respiratory sensitisation has not been reported for DINP or any other high molecular weight phthalates. In a study that examined the cytokine profile associated with bronchial asthama, no response was mediated by DINP (Butala et al,. 2004), suggesting little or no sensitizing potential. Therefore, it is assumed that DINP will not be a respiratory sensitiser.

Justification for classification or non-classification

No classification for skin/respiratory sensitization is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling, and packaging (CLP) regulation (EC) No 1272/2008.