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 sensitising potential of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate was evaluated in a repeated insult patch test (RIPT) with 106 volunteers (Harrison, 1999). Ten subjects discontinued the study due to personal reasons before the challenge part. This study was confirmed and informed consent free of coercion received in conformity with 21 CFR 50.25, Subtitle A, Protection of Human Subjects. 29 male and 77 female subjects between 18 and 68 years of age received a series of nine induction patches over a period of approximately three weeks. At every induction 0.2 mL of the test substance was applied with a patch, which remained in place and was kept dry for 24 h before removal. The test side was observed and scored 24 h afterwards. A rest period of approximately 14 days followed the last induction and subjects were challenged on their previously untreated site with 0.2 mL test substance for 24 h. The subjects were observed for skin reactions after 24, 48, 72, and 96 h. Only in one of 96 subjects a skin reaction was noted during the induction phase, which was classified as faint, minimal erythema. Since none of the subjects exhibited any skin reaction after the challenge application, no skin sensitisation was observed.

In conclusion, data from human repeated insult patch test indicate that 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate has no skin sensitising properties.

Migrated from Short description of key information:
Repeated insult patch test with human volunteers: not sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study in humans available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (E 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.