Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt

Endpoint summary

Description of key information

A Human repeated Insult Patch Test was performed with the registered substance (1% dilution). Under the conditions of this study, 1% dilution of the test material, did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.

Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation with a read across substance (CAS 37294-89-8 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 material on the Draize-Shelanski Test. It is unlikely that this material would present irritation or sensitisation in normal, intended use.

In summary, none of the tested sulfosuccinates showed skin sensitizing properties. The target substance is considered not to be sensitizing to the skin.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A Human repeated Insult Patch Test was performed with the registered substance (1% dilution). The test substance (1% dilution) was applied on the upper back of the volunteers using an occlusive dressing. Patches were applied 3 times per week for a total of nine applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent Induction patches at home, 24 h after application. The evaluation of this site was made again just prior to reapplication. Approximately 2 weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site. The patch was removed and the site scored at the clinic 24 and 72h post application.

Under the conditions of this study, 1% dilution of the test material, did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.

Sensitisation data with higher active ingredient concentration are not available for the registered substance, however read across data were available from a rea-across substance, CAS No. 37294 -49 -8 (Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt).

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 (supportingn study; 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. Therefore, it is unlikely that this material would present irritation or sensitisation in normal, intended use.

Conclusion

In all 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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

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