Registration Dossier

Administrative data

Description of key information

Not skin sensitising

Key value for chemical safety assessment

Skin sensitisation

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

Tall oil and diethanolamine (DEA) are the two primary metabolites of the target substance. This was confirmed with both the TIMES rat liver S9 metabolism model and the TIMES skin metabolism simulator. Therefore, the skin sensitization potential of the target substance should be fully satisified using these two source substances. For further information on the read across substances and metabolism of the target substance, see the Read Across Justification document in Section 13.

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 potential of the second read across test material, diethanolamine, to cause skin sensitisation was also 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 female Himalayan guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 5 % in saline and 5 % in saline/FCA for the intradermal and 25, 50, 75 and 100 % in physiological saline for the topical application.

In the challenge application, the animals were exposed to the test material at 25 % v/v in physiological saline.

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.

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 skin or respiratory sensitisation.