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:

Sensitisation data were not available for the registered substance, however read across data were available from a subgroup member, CAS No. 37294-49-8 (Disodium C-isodecyl sulphonatosuccinate). Further information supporting the safety of the test substance is provided in the read across justification for the Mono-ester subgroup (justification with data matrix separately attached in Section 13).

 

Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation:

- In the first study a batch with > 90% active ingredient was used (key study: Kligman, 1976).

- In the second study a batch with 37% active ingredient was used (Kligman, 1977).

The study design was as follows: a 15 mm patch with 300 mg test material (2.5% test material) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, 15 mm challenge patches (1% test material) of the material were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter, using the 0-4 scale.

In conclusion, it is unlikely that this material would present irritation or sensitisation in normal, intended use.

Conclusion

- In both studies, there were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

- This is also supported by data and negative group classification of the di-ester group (see separate read-across justification attached to Section 13).


Migrated from Short description of key information:
Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation with a read across substance (CAS 37294-49-8 or Disodium C-isodecyl sulphonatosuccinate): one with a batch containing > 90% active ingredient and one with 37% active ingredient. In both studies, there were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Justification for selection of skin sensitisation endpoint:
Key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data from read across, there was no indication for sensitisation from the Human Patch Test, classification for sensitisation is not warranted.