Registration Dossier

Administrative data

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 37294-89-8 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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached read-across justification
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
0
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
0
Key result
Reading:
other: 1st and 2nd reading
Group:
negative control
Remarks on result:
not measured/tested
Key result
Reading:
other: 1st and 2nd reading
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
There were no instances of irritation or sensitisation from this read-across test item on the Draize-Shelanski Test.
It is unlikely that this read-across test item would present a danger of irritation or sensitisation in normal, intended use.
Executive summary:

A modified Draize-Shelanski Repeat Insult Patch Test was conducted with a 15 mm patch with 300 mg read-across test material (2.5% test material with 90% act. ingr.) 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 with 90% act. ingr.) 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. There were no instances of irritation or sensitisation from this read-across material on the Draize-Shelanski Test. It is unlikely that this read-across material would present a danger of irritation or sensitisation in normal, intended use.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Sensitisation data are not available for the registered substance, however read across data were available from a category member, 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 (supporting 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 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 aslo supported by data and negative group classification of the di-ester group (see separate read-across justifciation attached to Section 13).

 

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 according to CLP (No. 1272/2008 of 16 December 2008.