Registration Dossier
Registration Dossier
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EC number: 211-522-5 | CAS number: 657-84-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The HYDROTOPES Category comprises the following 6 substances:
STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)
SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)
NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)
SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)
KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)
NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)
In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH.
OECD 471, Mutagenicity on Bacteria: All the available studies (STS, SXS, CaXS and SCS) showed no toxicity and no mutagenic effects at any dose level with any tester strain, in the absence and presence of S9 metabolic activation. Since there was no evidence of mutagenicity observed for any of the compounds with and without metabolic activation, it could be concluded that all the Hydrotrope category members does not induce reverse mutation in Salmonella Typhimurium and Escherichia coli. The substances for which the test is missing are assessed with the available data considering that the difference is only in the type of salt which is not considered to influence the behaviour of the substances.
OECD 476: The tested hydrotropes (STS and SXS) did not increase the frequencies of gene mutations in mammalian cells. The substances for which the test is missing are assessed with the available data considering that the difference is only in the type of Ccation which is not considered to influence the behaviour of the substances.
OECD 473: There are available in vitro studies for all the three subgroups (STS, SXS and SCS) which don't show any mutagenic effects. The substances for which the test is missing are assessed with the available data considering that the difference is only in the type of cation which is not considered to influence the behaviour of the substances.
OECD 479: There is availbale one in vitro study for SXS which is positive without metabolic activation and negative with metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
OECD 474: There are available in vivo studies on SCS and CaXS which don't show any mutagenic effects. The substances for which the test is missing are assessed with the available data considering that the difference is only in the type of salt which is not considered to influence the behaviour of the substances.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The HYDROTOPES Category comprises the following 6 substances:
STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)
SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)
NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)
SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)
KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)
NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)
In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH.
The available mutagenic data covers the three hydrotropes subgroups (toluene, xylene and cumene sulphonates) and all the results showed the absence of mutagenic effect. Since no positive results were seen in any of the studies, the chemicals in the hydrotropes category is considered not to have a genotoxic or mutagen potential. The density of the mutagenic data is high enough to consider the hydrotropes as a category and the available information support a regular pattern of same absence of and type of effects with regard to mutagenicity. The substances for which the test is missing are assessed with the available data on the other members considering that the difference in the type of cation or in the chemical structure is not considered to influence the behaviour of the substances.
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