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:

The sensitization potential of ARCOSOLV® DPnP was evaluated in this modified Buehler method dermal sensitization study. A test group of 10 male and 10 female Hartley albino guinea pigs was dosed topically with the test article one time per week for three weeks for a total of three induction exposures. The duration of each exposure was six hours. Two weeks after the last induction exposure, the animals were challenge-dosed for detection of sensitization by topical application of the test article to previously unexposed areas of skin. A Naive Control-I Group of 5 male and 5 female guinea pigs was dosed with the test article at challenge in the same manner as the Test Group and served as an irritation control. Reactions to challenge dosing were evaluated at approximately 24 and 48 hours after completion of exposure. Body weights and clinical observations were recorded at randomization (study day -1) and at study termination (study day 30).

There were no deaths, test article-related clinical findings or remarkable body weight changes during the study period. Following challenge dosing with ARCOSOLV® DPnP, there were no significant dermal reactions in the Test or the Naive Control Groups. The Incidence Index for the Test Group was 0% (0/20) following challenge dosing.

Under the conditions of this study, ARCOSOLV® DPnP was a non-sensitizer in albino guinea pigs.


Migrated from Short description of key information:
Skin sensitization study in guinea pigs

Justification for classification or non-classification

Based on the results of the study and Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, dipropylene glycol n-propyl ether will not be classified as a skin sensitizer.