Registration Dossier
Registration Dossier
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EC number: 215-211-5 | CAS number: 1313-82-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
A comprehensive literature search and evaluation programme for animal and human sensitisation data of sodium sulfide has been conducted. All data sources were assessed by expert toxicologists for quality and reliability, as well as relevance for regulatory risk assessment under REACH. The results are attached to the technical dossier in a tabular report (IUCLID section 13).
Based on the caustic alkaline nature of the substance with extreme pH and the skin corrosive properties, animal testing for sensitisation potential is not scientifically justifiable as it would not provide any information relevant for the human risk assessment. Additionally, testing with a corrosive substance is not required in accordance with section 8.3, column 2, Annex VII of regulation (EC) 1907/2006, the skin sensitisation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the skin and the substance is a strong base (pH≥11.5).
As a separate aspect, sulfides may be seen as ions endogenously occurring under physiological conditions, so that their role in normal human metabolism suggests that a sensitisation potential does not necessarily need to be expected.
Migrated from Short description of key information:
No data are available on skin sensitisation of sodium sulfide. As sodium sulfide is classified for skin corrosivity and has a pH value above 11.5 no testing need to be conducted.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data are available and no testing is required.
Justification for classification or non-classification
Sodium sulfide should not be classified as skin sensitiser or respiratory sensitiser for the following reasons:
According to EC Regulation No. 1272/2008, table 3.4.2 a, substances shall be classified as skin sensitisers (Category 1) in accordance with the following criteria:
(i) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or
(ii) if there are positive results from an appropriate animal test (see specific criteria in paragraph 3.4.2.2.4.1).
According to the CLP Regulation Annex I, Section 3.4.2.2 substances fulfilling the criteria for skin sensitisation will be classified as such in Category 1. If none of the above mentioned conditions are met (incl. specific considerations according to chapter 3.4.2.2.2), the substance need not be classified as a skin sensitizer. As for sodium sulfide no information, neither human nor animal data, is available, none of the specific conditions are fulfilled and no testing need to be conducted, it should not be classified as a skin sensitiser.
Substances shall be classified as respiratory sensitisers (Category 1) in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and /or
(b) if there are positive results from an appropriate animal test.
According to the CLP Regulation Annex I, Section 3.4.2.1 substances fulfilling the criteria for respiratory sensitisation will be classified as such in Category 1.
As no such information is available for sodium sulfide, no classification is proposed on respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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