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 sensitising potential of Monoethanolamine (MEA, 2 -Aminoethanol), as well as Di- and Triethanolamine (DEA and TEA), was studied using the guinea pig maximisation test (Wahlberg and Boman, 1996). Groups of 15 animals were induced with either MEA, DEA or TEA and then challenged after three weeks with the inducing amine and the two others. MEA was tested at concentrations of 0.6 % (intradermal) and 10.3 % (epicutaneous) for induction and 0.41, 2.05 or 4.1 % for challenge. Prior to the topical induction, pretreatment with 10 % Sodium dodecyl sulfate was carried out. The challenge reactions were read blindly 48 and 72 hours after application of the patches. Control groups of twelve animals were given the same treatment (FCA, vehicle, occlusion, etc.) except for the inducing amine. No statistically significant difference between actively induced animals and control animals was observed and there was no indication of cross reactivity.

One reliable animal study, according to OECD guideline 429 (Skin Sensitisation: Local Lymph Node Assay) was performed with Sodium nitrate which showed that the test substance had no sensitising properties at concentrations of 10, 25 and 50 % in 1% watery Pluronic L92 (NOTOX B.V., 2010; 493628). Since the within group variation was relatively high in this study, median values were used to interpret the data. Median DPM/animal values for the experimental groups treated with the test substance at concentrations of 10, 25 and 50 % were 704, 338 and 576 DPM, respectively. Median values of 363 and 1163 DPM were determined for the vehicle control group and the positive control group, respectively. The SI values calculated for the test substance concentrations 10, 25 and 50 % were 1.9, 0.9 and 1.6, respectively. Since there was no indication that the test substance elicited a SI 3 when tested up to a concentration of 50 %, the test substance was considered not to be a sensitiser.


Migrated from Short description of key information:
The salt (2-Hydroxyethyl)ammonium nitrate is considered highly unlikely to possess skin sensitisation potential. None of the read across substnaces that were tested displayed skin sensitising properties in reliable standard tests. These surrogate substances were 2-Aminoethanol and Sodium nitrate.

Justification for selection of skin sensitisation endpoint:
A weight of evidence approach is used to assess the skin sensitisation hazard of (2-Hydroxyethyl)ammonium nitrate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the current weight of evidence, (2 -Hydroxyethyl)ammonium nitrate is not subject to classification for skin sensitisation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS/CLP).