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:

The skin sensitizing potential of the test item 2,2',2''-Nitrilotriethanol, propoxylated was investigated in a guinea pig maximisation test according to OECD Guideline 406 (Skin Sensitisation). Male guinea pigs were treated intradermally (together with Freund's adjuvant) and epicutaneously (lowest irritating concentration) with the test item. 21 days after first administration, the test item was applied epicutaneously at the highest non-irritating concentration.

The local reactions recorded in the eight test animals (40 %) after the challenge were considered to be of irritant nature. This interpretation is supported by the fact that the reactions faded at the 48-hour reading and that 60 % of the control animals also showed a local erythema at the 24 -hour reading.

Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, 2,2’,2’’-Nitrilotriethanol, propoxylated does not have to be classified and labelled as a skin sensitizer.

An LLNA study was conducted according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay). Female CBA/Ca mice (five/group) received 0.5%, 5%, or 50% (v/v) test substance diluted using 4:1 acetone: olive oil (AOO). A stimulation index (ratio of 3H thymidine incorporation into lymph node cells of test nodes relative to that recorded for the control nodes) of 5.33 was recorded for the 50% w/v concentration of the test material. Stimulation indices of less than 3 (1.06 and 1.00) were determined for the 0.5 and 5 % dose groups. The EC3 value was calculated to be 25.79.

Considering the currently available studies, an occupational exposure incident and based on a weight of evidence approach, it is suggested that 2,2',2''-Nitrilotriethanol, propoxylated does not represent a skin sensitisation hazard to humans. 2,2',2''-Nitrilotriethanol, propoxylated is not a classifiable skin sensitiser and the result of the LLNA has to be regarded as a false positive. The weight of evidence approach document "Evaluation of the Skin Sensitizing Potential of 2, 2',2''-Nitrilotriethanol (Triethanolamine) Propoxylated, MW340" is attached in IUCID dataset (Section 7.4 sensitisation – endpoint summary).

Migrated from Short description of key information:
Non-sensitiser in a guinea pig maximisation test and in human occupational exposure incident. Weak sensitiser in LLNA.

Justification for classification or non-classification

Findings from a GPMT and in human occupational exposure incident do not warrant classification in the EU for skin sensitisation.