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:

For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis (2 -ethylhexyl) adipate and diisotridecyl dodecanedioate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across).

The sensitising potential of the component 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 the component 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 bis (2 -ethylhexyl adipate) was in a guinea pig test not sensitising.

A sensitisation study (Local Lymph Node Assay) with the read-across substance diisotridecyl dodecanedioate was performed on mice according to OECD Guideline for the Testing of Chemicals No. 429, adopted July 22, 2010 and Method B42 of Commission Regulation (EC) No. 440/2008.

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the undiluted test item or the test item as a solution in acetone/olice oil 4:1 at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.

The Stimulation Indeces expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were as follows:

25% test item in acetone/olive oil 4:1: SI = 2.87

50% test item in acetone/olive oil 4:1: SI = 2.80

100% test item (undiluted): SI = 1.99

As all results were negative (no threefold or greater increase in the Stimulation Index), the test item was considered to be a non-sensitiser under the condition of the test.


Migrated from Short description of key information:
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis (2 -ethylhexyl) adipate and Diisotridecyl dodecanedioate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across). In a human repeated insult patch test, the component diisotridecyl adipate did not show any indication of a sensitising potential. Also the analogue diisotridecyl dodencanedioate was not sensitising in a LLNA-test.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data have been located.

Justification for classification or non-classification

Based on studies with the component diisotridecyl adipate, the read-across substances bis(2 -ethylhexyl) adipate and diisotridecyl dodecanedioate it was demonstrated that the test substance Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is not sensitizing. According to EU Regulations (Directive 67/548/EEC and Regulation (EC) No 1272/2008), classification is not required.