Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate

Endpoint summary

Description of key information

Skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

In vitro studies were run to assess key event 2 and 3 of skin sensitisation, following OECD guideline 442D andd 442E, respectively.

In the test run according to OECD guideline 442D, the luciferase activity induction obtained with the test item was statistically significant above the threshold of 1.5 at 5.33 µM and above in the first test, meeting all acceptance criteria and the criteria for a positive response.

However, the luciferase activity induction obtained with the test item was not statistically significant above the threshold of 1.5 in the second test only was close to the threshold but did not cross it. Although the test met all acceptance criteria and was concluded valid, the criteria for a positive response were not fulfilled.

The luciferase activity induction obtained with the test item was statistically significant above the threshold of 1.5 at 5.33 µM and above in the third test, also meeting all acceptance criteria and the criteria for a positive response.

Since results of two positive tests were concordant out of the three valid tests, the overall result was concluded positive for luciferase gene induction.

In the study run according to OECD guideline 442E, both CD86 and CD54 marker expressions gave prevailingly positive results, thus the overall h-CLAT prediction was concluded positive.

Based on these results and the h-CLAT prediction model, the test item demonstrated an in vitro sensitizing potential under the experimental conditions of human Cell Line Activation Test.

The study is evaluated in a weight of evidence approach.

As the 2 studies gave concordant results, i.e. positive response to different key events of skin sensitisation, they were considered as sufficient to draw a conclusion on the skin sensitising potential of test substance.

Accordingly, test item was considered as skin sensitising.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin sensitiser means a substance that will lead to an allergic response following skin contact.

Based on a positive response in 2 in vitro tests assessing to 2 out of 3 key events of skin sensitisation, i.e. key event 2 (keratinocytes activation) and key event 3 (activation of dendritic cells), a skin sensitising potential is attributed to test substance.

Accordingly , the substance is classified as cat. 1 (H317: May cause an allergic skin reaction) within the CLP Regulation.

Based on available information, no conclusion on potency can be drawn, thus no subcategoritation, i.e. cat. 1A or 1B, can be attributed.