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Toxicological information

Endpoint summary

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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 diisotridecyl adipate was tested in two independent human repeated insult patch tests (RL2). In both tests, diisotridecyl adipate was demonstrated not to be sensitising.

 

The dermal sensitisation potential of diisotridecyl adipate was tested with human volunteers using a repeated insult patch test. 104 human subjects (19 males and 85 females) were divided into two groups (49 and 55 subjects) for semi-occlusive and occlusive application of test patches.

Induction exposure consisted of nine repeated 24 h exposures at the same site (left upper back). Test substance was administered on saturated patches (0.2 mL test substance) on Monday, Wednesday, and Friday for 3 weeks followed by a rest period of 2 weeks. After a single challenge exposure (24 h) on a virgin patch site (upper right back), the challenge reaction was evaluated 24, 48, and 72 hours after patch application.

No skin reaction in any of the 104 test subjects was observed either during induction exposure nor at any of the challenge readings.

In this study, diisotridecyl adipate did not exhibit any dermal sensitizing potential in humans (Zimmermann/Mobil/HRL 1,987).

The second test was performed using to the same method. A similar result was obtained.

The read-across substance diethylhexyl adipate was in a guinea pig test not sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data have been located.

Justification for classification or non-classification

In two human repeated insult patch tests, diisotridecyl adipate was demonstrated to be not sensitizing. According to EU Regulations (Directive 67/548/EEC and Regulation (EC) No 1272/2008), classification is not required.