Registration Dossier
Registration Dossier
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EC number: 215-211-5 | CAS number: 1313-82-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
General
A literature search and evaluation programme on animal and human genetic toxicity data of sodium sulfide and sodium hydrogensulfide 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 atabular report (IUCLID section 13).
Results:
All three available studies performed with sodium sulfide yielded negative results concerning genetic toxicity:
- in a reliable in-vitro HPRT test (Stone_2010) it is concluded that sodium sulfide, anhydrous did not induce mutation at thehprtlocus of mouse lymphoma cells when tested under the conditions employed in this study.
- in a reliable in-vitro Ames test (reverse gene mutation assay) reported by Engelhardt_1989 it is concluded that sodium sulfide is not mutagenic under the experimental conditions.
- a reliable in-vivo micronucleus test (Gocke_1981) also gave had a negative result: no significant exerted mutagenic action was observed.
The REACH requirements according to the endpoints in section 8.4, Annex VII-X in Regulation (EC) 1907/2006 are fulfilled. No further testing is required.
Short description of key information:
In-vitro studies:
- The HPRT test (Covance_2010) performed with sodium sulfide (anhydrous) according to OECD guideline 476 was rated as RL=1 (reliable without restrictions) and used as a key study. The study had a negative result for induction of mutation at the hprt locus of mouse lymphoma cells.
- The key study on in vitro gene mutation of sodium sulfide (bacterial reverse mutation assay; Engelhardt_1989) was rated as reliable with restrictions and had a negative result for mutagenic properties.
In-vivo studies:
- Chromosome aberration of sodium sulfide has been tested in-vivo in a micronucleus assay performed in mice similar to OECD guideline 474 (Gocke_1981). This study was rated as reliable with restrictions (RL=2) and is used as a key study. The study had a negative result.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
All available reliable studies showed no genetic toxicity for sodium sulfide. Thus, no classification is required for sodium sulfide.
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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