(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

No studies on the skin sensitising properties of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One local lymph node assay is available for the structural analogue (+)-Pseudoephedrine.

In a local lymph node assay, performed according to OECD Guideline 442B and GLP, three groups of 5 CBA/CaOlaHsd female mice were treated on the dorsal surface of both ears once per day for 3 days with 2.5, 5, 10% of (+)-Pseudoephedrine, with the vehicle alone (propylene glycol) or with the positive control (α-hexyl cinnamaldehyde) at 25% (BASF 2012). The mice were observed daily and no irritation at the dosing site or other signs of toxicity were noted. Four days after the first topical application the mice were intraperitoneally injected with BrdU. Approximately 24 hours after intraperitoneally injection, the mice were sacrificed and the draining auricular lymph nodes excised, pooled per animal and immediately weighed. The proliferative capacity of pooled lymph node cells was determined by the incorporation of BrdU measured in a photometer.A statistically significant increase in BrdU labeling was observed for the mid (5%) and high (10%) dose group. This was also observed for all dose groups in lymph node weights and lymph node cell count. Furthermore, the cut-off-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was exceeded in the high dose group (index of 2.4). In this study Stimulation Indices (S.I.) of 1.2, 1.7 and 3.1 were determined with the test item at concentrations of 2.5, 5 and 10 % (w/w) in propylene glycol. Based on the S.I.s obtained with 2.5 and 5% test item concentration, an EC1.6 value of 4.5% (w/w) was calculated. The test item(+)-Pseudoephedrine was found to be a skin sensitizer under the test conditions of this study.

Migrated from Short description of key information:
(+)-Pseudoephedrine, a structural analogue of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride is considered to be a skin sensitizer under the test conditions of a GLP-compliant LLNA study (OECD Guideline 442B).

Justification for selection of skin sensitisation endpoint:
There is one Local Lymph Node Assays with mice available for a structural analogue of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride. The study is performed according to OECD 442B and according GLP. The study is sufficiently adequate for this endpoint.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

(+)-Pseudoephedrine is a structural analogue of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride. Because(+)-Pseudoephedrine is skin sensitizing it is suspected that (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride is also skin sensitizing. Therefore (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride is classified as Xi:R43: May cause sensitisation by skin contact in accordance with Directive 67/548/EEC (DSD) and Cat 1:H317: May cause an allergic skin reaction in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.