Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In a key study the sensitisation potential of the read-across substance Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts containing 39.80% active ingredient was tested in guinea pigs in a test model according to Magnusson and Kligman. 0.5% concentration for the 1st (intracutaneous) and 25% suspension for the 2nd (topical) induction were used, versus a 10% suspension for the challenge. Under the present test conditions, there was no sensitisation. In a supporting sensitisation study in guinea pigs , intracutaneous injection with 1% SBU 185 (50 %)   was done for 10 times, followed by challenge  2 weeks after the 10th injection. There was no sensitisation, however no control groups were included in this study.

Key value for chemical safety assessment

Skin sensitisation

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

In a key study (LPT, 2013), the sensitisation potential of the read-across substance Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts containing 39.80% active ingredient was tested in guinea pigs in a test model according to MAGNUSSON and KLIGMAN. From a preliminary experiment, it was decided to use a 0.5% concentration in aqua ad iniectabilia for the 1st (intracutaneous) stage, a 25% suspension in aqua ad iniectabilia for the 2nd (topical) induction stage and a 10% suspension in aqua ad iniectabilia for the challenge. A 0.5% suspension in aqua ad iniectabilia 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 a 25% suspension of the test item in aqua 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. Behaviour of the animals remained unchanged. Body weights were not affected. Under the present test conditions, read-across test item containing 39.8% active ingredient, was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

In a supporting sensitisation study (Evonik, 1965) an area of the body surface on the back and the flanks of 10 white guinea pigs was clipped free of hair. A 1 % solution of SBU 185 (50 %) in distilled water was injected intracutaneously, using a 26-gauge hypodermic needle. The injections were made every other day or three times weekly, until a total of ten had been made. The first injection consisted of 0.05 mL, while the remaining 9 injections consisted of 0.1 mL each. 2 weeks after the 10th injection a retest injection was made, using 0.05 mL of a freshly prepared solution, as before. 24 hours following injections, readings were made of the area, height and color of reaction. A comparison of the reaction following retest was made with the average of the readings taken after each of the original 10 injections. No negative and no positive control groups were included in the test. According to the interpretation of the study authors, the sample SBU 185 tested did not show to be a sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on these results of registered and read-across substances, no classification and labelling is needed for skin sensitisation according to theCLP regulation(No. 1272/2008 of 16 December 2008).