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:

Test data were available for the registered substance, however read-across data were also used from N2 and N3 subgroup members as weight-of-evidence:

- 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts'
- 'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts'.
Justification for read across within the category of N-containing sulphosuccinates (N2 and N3 subcategories) is documented in a separate document attached in Section 13.

 

Guinea-pig maximization
- In a skin sensitisation study with the registered substance according to the method of Magnusson and Kligman, 2 groups (test and control group) of 20 animals each were tested with the registered substance containing 40% active ingredient (Sterner and Chibanguza, 1988). Intradermal induction was done in 10 male and 10 female control and test animals with 0.05 mL. Test group:1 pair (2) injections of test substance 10% solution (4% active ingredient) in deionised water; 1 pair (2) injections of test substance 10% solution in FCA and 1 pair (2) injections of FCA undiluted. Control group:1 pair (2) injections of FCA undiluted; 1 pair (2) injections of deionised water 10% solution in FCA and 1 pair (2) injections of deionised water undiluted. Epicutaneous induction was done, 7 days after intradermal induction; the first dermal treatment started with 0.5 mL of the test substance (50% solution= 20% active ingredient) on the left flank and 0.5 mL vehicle (deionised water) on the right flank in a closed patch test. After 48 hours the dressing was removed. Challenge, 3 weeks after intradermal treatment, was done with 0.5 mL of the test substance (50% solution = 20% active ingredient ) on the left flank and 0.5 mL vehicle (deionised water) on the right flank. After challenge with 50% solution (20% active ingredient), there was 1 animal in the test group with slightly erythema at 24h evaluation. At 48h after challenge none of the 20 animals of the test group had any reaction. In the control group after 24 and 48h there were no reactions on the test site or the control site. In 19 of the 20 test animals no reaction was observed, thus the test substance (50% solution or 20% active ingredient) can be classified as “probably not sensitising”. The significant irritation in 1 test animal can still be assigned to chance.
- In a skin sensitisation study with read-across substance 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts' according to the method of Magnusson and Kligman in guinea pigs, the test item containing 39.80% active ingredient was tested for its sensitising properties (Haferkorn, 2013d).A 0.5% suspension inaqua ad iniectabiliachosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 mL of a 25% suspension of the test item inaqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed a moderate and confluent erythema 48 hours and a discrete or patchy erythema 72 hours after start of exposure in all 10 animals. The challenge with 2 mL of a 10% suspension of the test item in aqua ad iniectabilia /animal - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions.

Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).Behaviour of the animals remained unchanged. Body weights were not influenced. The test item containing 39.80% active ingredient, was found to be not sensitising.

 

Human patch testing
In a skin sensitisation study with read across substance 'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts', a 15 mm patch of the test item containing 35.8% active ingredient (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 (Kligman, 1977). Following a seven-day rest period, 15mm challenge patches of the test item (1% 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, using the 0-4 scale. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Patch Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Conclusion
- Based on the negative findings in the guinea-pig maximisation and human patch testing, potential for skin sensitisation of registered substance can be excluded.

- Further information supporting the absence of sensitisation potential is also provided in the read across justification for the N2 & N3 subgroups, showing that other guinea-pig maximisation was also negative (justification with data matrix separately attached in Section 13).

 

 


Migrated from Short description of key information:
Weight-of-evidence on sensitisation potential was available from registered substance and following read across substances in n a guinea pig maximisation model and human patch test all indicated there is no sensitisation potential:
-'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts'
-'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts'.
Bassed on the negative findings in both models for different similar substances, potential for skin sensitisation can be excluded

Justification for selection of skin sensitisation endpoint:
Study with registered substance

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for sensitisation.