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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 37294-49-8 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.

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 for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
0
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
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:
GHS criteria not met
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 material on the Draize-Shelanski Test. It is unlikely that this 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 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).


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 under CLP (No. 1272/2008 of 16 December 2008) for sensitisation is not warranted.