Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

No data/information is available for sodium ethanolate. It is classified as corrosive according to Annex I of the Dangerous Substance Directive (67/548/EEC) and Annex VI of the CLP regulation (EC 1272/2008), testing concerning skin sensitization is not necessary/meaningful.

Four studies are available for the reaction products ethanol and sodium hydroxide (NaOH).

BP Chemicals Ltd. (1984) reported a guinea pig maximization test using ethanol (CAS: 64-17-15). Ethanol did not show any signs of sensitizing properties.

In a mouse ear swelling test, ethanol was applied intradermally and epicutaneously to Swiss mice. The degree of contact hypersensitivity based on ear swelling was quantified 24 and 48 hours after application. Ethanol was found not to cause any statistical increase in ear swelling and therefore showed no sensitizing properties (Descotes, 1988).

Lalko et al. (2004) reported a mouse local lymphnode assay (LLNA) performed equivalent to OECD guideline 429. No sensitizing properties were detected for test compound ethanol.

For the second reaction product NaOH (CAS: 1310-73-2), a human patch test is available. Here, results gave also no indication for sensitization.

Justification for classification or non-classification

No data/information are available for sodium ethanolate.

Since no structural alert exists and sodium ethanolate is classifed as a corrosive substance, testing concerning skin sensitization is not necessary/meaningful. No classification is proposed.