Fatty acids, C14-18 and C16-18-unsatd., maleated

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Read across justification

The test item is an UVCB and composes mainly of modified fatty acids from sun flower oil (mSOFA) and, to a minor part, of modiefied fatty acids from tall oil (mTOFA). The fatty acids obtained from tall oil and sun flower oil are of comparable chain lenghth and are modified by the same reaction step. In contrast to mTOFA, mSOFA is also produced solely by the very same reaction as the UVCB and consists therefore of the same reaction products and similar impurities. Furthermore, mSOFA was intentively examined for its toxicological properties. Thus, it is acceptable to derive data on skin sensitization from the read across substance mSOFA.

Method and observation

The dermal sensitizing potential of the test item was investigated on the basis of the methods of the OECD Guideline 406; the test developed by BUEHLER (1965)1 and known as Buehler testwas used. The main study started with an induction phase including an occlusive patch topical application for 6 hours once a week for three consecutive weeks. The animals of the test group 2 were induced with the 50% (w/w) test item whereas the animals of the control group 1 were induced with PEG E 400.

A discrete or patchy erythema as well as very slight and local erythema were observed in test group animals after the first, second and third induction. The 6-hour challenge procedure of an occlusive topical application of the test item on the right flank of all animals followed four weeks after the first induction. The skin reactions were evaluated 24 hours and 48 hours after the challenge application. For the challenge the test item was used in a concentration of 10 % (w/w). ln the test group 11 out of 20 animals responded with a sl ight skin reaction to the challenge treatment with the test item after 24 hrs and/or 48 hrs. ln the control group, none of the animals responded with skin reactions to the challenge treatment with the test item. Due to the frequency of positive skin reactions in the test group (55%) compared to the control group being free of any reactions, the sensitization potential of the test item has been sufficiently shown in the challenge. Therefore and in agreement with the sponsor, it was waived to perform a rechallenge.

Conclusion

Under the experimental conditions described in this report, the test item caused a delayed contact hypersensitivity. Based on results of the non-adjuvant sensitization study described in this final report, the test item shall be classified as a skin sensitizer according to the regulation (EC) No 1272/2008 (2008)5 and the GHS (2009).

Migrated from Short description of key information:
he dermal sensitizing potential of the test item was investigated on the basis of the methods of the OECD Guideline 406; the test developed by BUEHLER (1965)1 and known as Buehler testwas used. ln the test group 11 out of 20 animals responded with a slight skin reaction to the challenge treatment with the test item after 24 hrs and/or 48 hrs. Under the experimental conditions described in this report, the test item caused a delayed contact hypersensitivity.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 286/2011).