Registration Dossier
Registration Dossier
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EC number: 231-820-9 | CAS number: 7757-82-6
Carcinogenicity
Administrative data
Description of key information
The substance is found to be non-mutagenic from the conclusions of the genetic toxicity tests, and no adverse effects are predicted from repeated dose studies with sodium sulphate.
A study was reported by Blunck and Crowther (1975), in which the carcinogenicity of sodium sulphate was determined. Due to the limited number of endpoints as well as the low number of animals, it is not enough to make an assessment on the reliability of the findings presented. In this study, two groups of 5 male rats were fed 2% sodium sulfate in the diet for 27 and 44 weeks respectively. No adverse effects were detected with respect to the limited number of endpoints reported from this study.
Further, a study by Toth (1987), in which mice were exposed subcutaneously with sodium sulphate for 26 weeks (once per week). Tumor incidences were 0% and 2% in females and 4% and 0% in males. Due to methodological deficiencies, it is not sufficient for an assessment on reliability of the results.
However, the results of these data are in line with the available data on further toxicity endpoints, reporting no toxicity of sodium sulphate. Based on these data, testing for this endpoint is not required.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with CLP criteria, sodium sulphate does not require a classification for carcinogenicity based on the fact that the substance is not classified as mutagen category 2 as well as no findings on hyperplasia and/or pre-neoplastic lesions were found in repeated dose toxicity studies. Further, available data on carcinogenicity did not show any carcinogenic potential of sodium sulphate.
Additional information
According to column 2 (specific rules for adaptation from column 1) point 8.9.1, under Annex X of the regulation EC no. 1907/2006, a study may be proposed if:
- the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and
- the substance is classified as mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
A study was reported by Blunck and Crowther (1975), in which the carcinogenicity of sodium sulphate was determined. Due to the limited number of endpoints as well as the low number of animals, it is not enough to make an assessment on the reliability of the findings presented. In this study. two groups of 5 male rats were fed 2% sodium sulfate in the diet for 27 and 44 weeks respectively. No adverse effects were detected with respect to the limited number of endpoints reported from this study.
Further, a study by Toth (1987), in which mice were exposed subcutaneously with sodium sulphate for 26 weeks (once per week). Tumor incidences were 0% and 2% in females and 4% and 0% in males. Due to methodological deficiencies, it is not sufficient for an assessment on reliability of the results.
The substance is found to be non-mutagenic from the conclusions of the genetic toxicity tests, and no adverse effects are predicted from repeated dose studies with sodium sulphate. Based on this data, testing for this endpoint is not required.
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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