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:

No test data were available for registered substance, however read across data were available from CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate) and CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt). Justification for read across within the category of sulfossuccinates Di-esters is documented in a separate document attached in Section 13.

Modified Draize-Shelanski Repeat Insult Patch Tests were carried out with

- CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate), with a batch containing > 90% active ingredient (Key study; Kligman, 1976a). Approximately 33 mg of the test item (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test.

- CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt), with a test item containing 96 -98% active ingredient (Kligman, 1976b). Approximately 300 mg of the test item (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. There were no instances of irritation or sensitisation from these materials in the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

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

Conclusion

- Based on the repeated absence of sensitising potential in Repeat Insult Patch Tests, it is unlikely that this test item would present irritation or sensitisation in normal, intended use.

- Further information supporting the absence of sensitisation potential is provided in the read across justification for the Di-ester category, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13). 

 


Migrated from Short description of key information:
Read-across was performed with CAS No. 23386-52-9 containing > 90% active ingredient and CAS No. 848588-96-5 containing 96-98% active ingredient . Modified Draize-Shelanski Repeat Insult Patch Tests demonstrated no irritation and no sensitisation potential. 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

As there was no indication for sensitisation from the human patch test with current test item and category analogues, classification for skin sensitisation is not needed according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).