Disodium (Z)-4-(9-octadecenylamino)-4-oxo-2(or 3)-sulphonatobutyrate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No data were available for registered substance, however data were available for read-across substances:
- 'Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts'
- CAS 68988-69-2 'Butanoic acid, 4-amino-4-oxosulfo-, N-tallow alkyl derivs., disodium salts'.
Justification for read-across with category members is provided in Section 13.

 

- In a key sensitisation study, 'Butanoic acid, 4-amino-4-oxo-2(or3)-sulfo-, N-(C16-C18 (even numbered), C18unsaturated alkyl), disodium salts' was tested in the skin sensitisation test in guinea pigs according to Magnusson and Kligman (Maximisation test) (Haferkorn, 2013b). A 0.1% in tap water chosen 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 the undiluted test item/animal chosen for the 2nd (topical) induction stage revealed a moderate and confluent erythema in all 10 animals 48 and 72 hours after administration. The challenge with 2 mL of a 10% suspension of the test item in tap water/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.

- A supporting skin sensitisation study with CAS 68988 -69 -2 'Butanoic acid, 4-amino-4-oxosulfo-, N-tallow alkyl derivs., disodium salts' (Kligman, 1977) was performed as a Modified Draize-Shelanski Repeat Insult Patch Test. A 15 mm patch of the test item (test item 2.5% in petrolatum, about 300 mg) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, 15 mm challenge patches ( test item 1.0% in petrolatum, about 300 mg) 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 Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

- A study with same test substance was also available with a 50% boric acid solution of the test item (test item containing 35% active ingredient) (Hollander, 1944), however this study was not considered adequate and reliable. As only few data were available on test design and the negative control showed a high positive reaction rate, the study is considered not adequate an not reliable. Therefore it was disregarded.

- In conculsion, there were no instances of sensitisation in the guinea pig maximisation test and the Draize-Shelanski test. It is unlikely that this material would present a danger of sensitisation in normal, intended use.

Conclusion

- Based on the negative outcome of sensitisation in the guinea pig maximisation test and the Draize-Shelanski test with read-across substances, it can be assumed that there is no sensitisation potential for the structurally similar registered substance.

- This was further supported by the read-across justification (see Section 13).

Migrated from Short description of key information:
No data were available for registered substance, however key data were available for read-across substance 'Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts'. Induction with 0.1% suspension (intracutaneous) and 2 mL of undiluted test item , followed by challenge with 2 mL of a 10% suspension of the test item - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. A support skin sensitisation study with CAS 68988-69-2 'Butanoic acid, 4-amino-4-oxosulfo-, N-tallow alkyl derivs., disodium salts' was performed as a Modified Draize-Shelanski Repeat Insult Patch Test, demonstrating no instances of irritation or sensitisation from this material. Therefore there are no indications for skin irritation potential of registered substance.

Justification for selection of skin sensitisation endpoint:
Key study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

As there was no indication for sensitisation from the Guinea-pig Maximisation test, classification for skin sensitisation is not needed according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).