Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The dermal sensitizing potential of Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated was investigated on the basis of the methods of the OECD Guideline 406 (1992), the council regulation (EC) No 440/2008 part B.6. (2008) and the U.S. EPA guideline OPPTS 870.2600 (2003). The test developed by BUEHLER (1965) and known as Buehler test was used.

Buehler assay, BASF SE 2013 (key study)

The purpose of this skin sensitizing study was to assess the possible allergenic potential of the test item when administered topically to guinea pigs. 20 female animals of the test group were treated topically with the test item applied at a concentration of 75 % and challneged 25 % in PEG (highest concentration to cause mild irritation) once a week for a 3 week induction phase. Two weeks after the final induction application all animals were treated with the vehicle PEG or with the test item at a concentration of 25 % . The ten animals of the control group were not treated during the induction. They were only treated as the test animals at the challenge. No cutaneous reactions were observed in the control group after challenge with the test item or in control and test group animals after treatment with the vehicle alone. In the test group 8/20 animals and 11/20 animals showed skin reactions 24 h and 48 h after challenge with the test item, respectively. Therefore, the test item is considered to be sensitising to the skin.

Buehler assay, BASF SE 2012 (disregarded)

The dermal sensitizing potential of Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated was investigated on the basis of the methods of the OECD Guideline 406 (1992), the council regulation (EC) No 440/2008 part B.6. (2008) and the U.S. EPA guideline OPPTS 870.2600 (2003). The test developed by BUEHLER (1965) and known as Buehler test was used.

The main study was performed on 30 guinea pigs in total. A control group of 10 animals and a test group of 20 animals were formed.

The test concentrations for the main study were selected based on the results of the preliminary investigations.

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 2.5 % (w/w) test item Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated in water (Aqua dest.), whereas the animals of the control group 1 were induced with water (Aqua dest.).

All control group animals did not show any signs of skin irritation during the induction phase. A discrete or patchy erythema (grade 1) was observed in four test group animals after each induction as well as a moderate and confluent erythema (grade 2) with local unevenness and formation of scales was seen in one of the test group animals after the first 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 0.5 % (w/w) in water (Aqua dest.). In the test group 8 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. In the control group, 2 of 10 animals responded with a slight skin reaction to the challenge treatment with the test item. The test fields treated with the vehicle water (Aqua dest.) were free of any reaction in both of the two groups.

A safe positive assessment of the skin reactions was initially impossible, because comparable erythema were observed in the control group 1 and the test group 2. But the more frequent appearance of the skin reactions in the test group supplied clues for a sensitisation potential of the test item.

Due to these unclear findings, a rechallenge was performed according to the agreement with the sponsor.

The 6-hour rechallenge procedure of an occlusive topical application of 0.25 % (w/w) of the test item on the left flank of all animals followed two weeks after the challenge. The skin reactions were evaluated 24 hours and 48 hours after the rechallenge application.

For the rechallenge the test item was used in a concentration of 0.25 % (w/w) in water (Aqua dest.). In the test group 6 out of 20 animals responded with a slight skin reaction to the rechallenge treatment with the test item after 24 hrs and/or 48 hrs. In the control group, 1 of 10 animals responded with a slight skin reaction to the rechallenge treatment with the test item. The test fields treated with the vehicle water (Aqua dest.) were free of any reaction in the control group, whereas a discrete or patchy erythema was observed in 1 of 20 animals of the test group after 24 hrs and 48 hrs. No clear conclusion can be drawn from the available data set. The study was thus concluded to be invalid and is not taken into account for risk assessment.

Migrated from Short description of key information:
The test item is considered to be sensitising to the skin as it revealed an allergenic potential in the Buehler assay.

Justification for selection of skin sensitisation endpoint:
The key study was selected.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the data available the test item is classified as skin sensitizer Cat 1 B / H317 (may cause an allergic skin reaction)according to Regulation (EC) 1272/2008 (CLP) and R43 (may cause sensitisation by skin contact) according to Directive 67/548/EEC (DSD).