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 sensitizing potential of amides, C8-18 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 test animals. Two to three hours later, 6 intracutaneous injections were made, simultaneously 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 material in maize oil was applied to freshly shaved skin. The whole 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 hours, a 2x2 cm filter paper with 20% test substance in maize oil was applied for 24 hours 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. 24 and 48 hours after removal of the adhesive bandage, the reaction was scored. No animals showed any effects to the treatment. Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) was therefore considered non-sensitizing under the conditions of the study (Mürmann P, 1990).

A study was performed to determine the delayed contact hypersensitivity potential of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) in 20 female Pilbright guinea-pigs according to OECD Guideline 406. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injectionswere given (0.1ml Freund's adjuvant; 0.1 ml of a 5% solution of Comperlan COD in propylene glycol, and 0.1 ml of a 1:1 mix of Freund's adjuvant and 5% test substance.One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 days after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the test conditions, test material did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitizing (Potokar (1982).


Migrated from Short description of key information:
The available in vivo skin sensitisation studies suggest that amides, C8 -18 and C18 -unsatd., N, N-bis(hydroxyethyl) is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Both studies are of good quality and assigned KL2.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Although no information is currently available, amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) is not expected to be a respiratory sensitiser based on the available toxicological data.

 


Migrated from Short description of key information:
Although no information is currently available, amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) is not expected to be a respiratory sensitiser based on the available toxicological data.

Justification for classification or non-classification

Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) was negative inin vivoskin sensitisation tests and therefore no classification is required for sensitisation according to EC (67/548/EEC) and CLP (EC 1272/2008) criteria.