Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

A study was conducted to assess the sensitising potential of the read across substance, amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), in a guinea-pig maximisation test according to OECD Guideline 406. A 4 x 6 cm2 area was shaved on the shoulders of the test animals. Two to three hours later, 6 intracutaneous injections were made, simultaneously on the right and left: 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 of 0.5% test substance in maize oil, 0.1 cm3 of 0.5% test substance in FCA/water (1+1). Controls received 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 maize oil, 0.1 cm3 of FCA/maize oil (1+1). One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test substance in maize oil was applied to freshly shaved skin. The skin was covered with an adhesive bandage for 48 h. Controls received maize oil. Two weeks later, the right and left flanks were shaved. After 2 - 3 h, a 2 x 2 cm filter paper with 20% test substance in maize oil was applied for 24 h to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil. At 24 and 48 h after removal of the adhesive bandage, the reaction was scored. No effects were noted. Under the conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising (Mürmann, 1990).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance is not expected to be a skin sensitiser based on a negative in vivo skin sensitisation study conducted on a structurally similar substance. Therefore no classification is required for sensitisation according to CLP (EC 1272/2008) criteria.