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:

Data are available for the corresponding sodium salt of the substance, docusate sodium, and other substances of similar structure. These data are used for read-across to the substance registered.

A key sensitisation study for docusate sodium was conducted according to the modified Draize-Shelanski Repeat Insult Patch Test with approximately 300 mg docusate sodium applied to patch sites on the backs or volar forearms of 100 human subjects for ten alternate-days during 24 hour periods under occlusion (Cytec, Kligman 1977). Following a seven-day rest period, challenge patches of the material 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. Although some subjects had mild irritation during induction, there was no sensitisation after challenge.

Sensitisation assays were also available from other category members as supporting information. 

For a formulated product containing 44-46% CAS No. 127-39-9 (sodium di-iso-butyl sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1977).

For a formulated product containing 78-80% CAS No. 2373-38-8 (sodium dihexylsulfosuccinate), there were no instances of irritation or sensitization. (Cytec, Kligman 1976a).

For a formulated product containing approximately 70% CAS No. 2763 -22 -5 (bis (tridecyl) sodium sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976b).

For a test substance with >97% CAS No. 922-80-5 (sodium diamylsulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976c).

In summary, no skin sensitization was observed with docusate sodium and structural similar chemicals, hence it is unlikely that the registered substance has sensitization potential. Further testing is not recommended/proposed based on this information.

Migrated from Short description of key information:

Sensitisation studies according to the modified Draize-Shelanski Repeat Insult Patch Test were negative for skin sensitisation for docusate sodium and for various category members as supporting information.  Therefore it is unlikely that thes substance regsitered has sensitization potential for the skin.

Justification for classification or non-classification

As there was no skin sensitisation observed, there is no indication for classification.