Tall oil, compd. with ethanolamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The potential of the read across substance distilled tall oil to cause skin sensitisation (delayed contact hypersensitivity) was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. It was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997).

Twenty albino Dunkin-Hartley guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 7.5 % v/v in Alembicol D for the intradermal application and undiluted test material for the topical application.

In the challenge application, the animals were exposed to the test material as supplied and 50 % v/v in Alembicol D.

No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals.

Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.

The second read across maximisation test was obtained from a reliable secondary source (MAK. 33rd update, 2001)and was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997).

Two guinea pig maximisation tests were carried out; one used water as the vehicle and the second used saline as the vehicle.

In each experiment, 15 Dunkin-Hartley guinea pigs were treated with 0.6 and 10.3 % of the test material for intradermal and topical induction, respectively. Before the topical induction, the animals were treated topically with 10 % sodium dodecyl sulfate. Three weeks after induction, the animals were challenged with 4.1, 2.05 and 0.41 % of the test material, using water or saline as a challenge control.

In the experiment using water as the vehicle, after challenge with 4.1, 2.05 and 0.41 % of the test material, 3/15, 2/15 and 3/15 animals reacted positively,respectively, after 72 hours. 2/15 of these animals showed a reaction to the challenge control of water only. Of the 12 control animals, none reacted to the test material or the vehicle.

In the experiment using saline as the vehicle, after challenge with 4.1, 2.05 and 0.41 % of the test material, 1/15, 1/15 and 0/15 animals reacted positively after 72 hours. 0/15 of these animals showed a reaction to the challenge control of saline only. Of the 12 control animals, none reacted to the test material and 1 reacted to the vehicle.

Under the conditions published in this study, the test material is considered a non-sensitiser in accordance with EU criteria.

On the basis that the read across components that make up the substance itself are both non-sensitisers, it is considered that Tall Oil, compound with ethanolamine can be considered to be a non sensitiser also.

Migrated from Short description of key information:
In a guinea pig maximisation test, the read across material tall oil was determined not be a sensitiser.

In a second guinea pig maximisation test, the read across material monoethanolamine was also determined not to be a sensitiser.

Justification for selection of skin sensitisation endpoint:
No one study is selected on the basis that this endpoint is covered by read across to two key studies. One study is provided on the material tall oil, the other is provided on the material monoethanolamine (2-aminoethanol). It is considered that these studies together are an accurate reflection of the total composition of the registered substance, Tall Oil, compound with ethanolamine.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for sensitisation.