2-(methylamino)ethanol, compound with sulphur dioxide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitising potential of 2 -(Methylamino)ethanol was assessed in a guinea pig maximisation test according to Magnusson and Kligman (Leung and Blaszcak, 1998). Pretest screening allowed the selection of test substance concentrations for the induction (5 % and 25 % for intradermal and epicutaneous induction, respectively) and challenge phases (5 % for epicutaneous challenge). In this study, 18/20 animals challenged with a 5 % concentration of the test substance were free of a skin response, and the remaining 2/20 animals displayed a clear skin response (score 1) at 24 hours but not at 48 hours after dosing. No skin response occurred in the irritation control animals treated at the same concentration. On this basis, 2 -(Methylamino)ethanol was considered to have a low skin sensitisation potential in guinea pigs. In view of the low incidence (2/20 animals, 10 %) of positive responses noted, the test substance does not meet the EU criteria for classification as a skin sensitiser.

One reliable animal study, conducted according to OECD guideline 429 (Skin Sensitisation: Local Lymph Node Assay, modified according to Ehling et al., 2005) was performed for Sodium sulfite which showed that the test item had no sensitising properties at concentrations of 10, 25 and 50 % in aqua ad iniectabilia (LPT, 2010; 25738). The positive control group caused the expected increases in lymph node cell count (S.I.: 2.106) (statistically significant at p ≤ 0.01); the stimulation index for lymph node weight was 2.160 and for ear weight 1.040. In a similar study conducted according to the same protocol with Disodium disulfite at concentrations of 10, 25 or 50 % in aqua ad iniectabilia (LPT, 2010; 25740), no skin sensitising properties were noted. The positive control group caused the expected increases in lymph node cell count (S.I.: 2.427) and lymph node weight (S.I.: 2.160) (statistically significant at p ≤ 0.01). The stimulation index for ear weight was 1.033. In both studies, the stimulation indices in the test groups were below the respective threshold values.

Nevertheless it has to be mentioned that in human individuals urticaria and asthma with itching, edema, rhinitis, and nasal congestion were reported (OECD SIDS; 2004) An immunological pathogenesis of these findings are not still clear.

Migrated from Short description of key information:
The salt 2-(Methylamino)ethanol, compound with Sulfur dioxide, is considered highly unlikely to possess a relevant skin sensitisation potential. Among the ions/salts that result from its dissociation in aqueous systems and that were tested in reliable standard studies with counterions of no toxicological significance (Na+, H+) only 2-(Methylamino)ethanol displayed slight skin sensitising properties, without relevance for classification. The surrogate substances Sodium sulfite and Disodium disulfite were shown to be no skin sensitisers.

Justification for selection of skin sensitisation endpoint:
A weight-of-evidence approach is used to assess the skin sensitisation hazard of 2-(Methylamino)ethanol, compound with Sulfur dioxide.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

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