Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-210-1 | CAS number: 16066-35-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There is a fully documented, GLP Guideline (OECD 471) Ames Test (Hoechst, 1988a) and a fully documented, GLP Guideline (OECD 473) Chromosome Aberration Test (Hoechst, 1988b) for one of the aromatic sulphonic acids, p-toluenesulphonic acid (CAS No. 104-15-4). Both tests were conducted with and without metabolic activation. The Ames test exposed up to 5000 micrograms/plate and the chromosome aberration test exposed up to 1902 micrograms per liter of the test substance. These studies conclude the substance is neither mutagenic norcytotoxic.
There is an additional, published report (Zeiger, 1988) of an Ames Test for another of the aromatic sulphonic acids, benzenesulphonic acid (CAS No. 98-11-3). Exposures up to 10,000 micrograms/plate were done with and without metabolic activation. The conclusion is the same as for the p-toluenesulphonic acid; that is, not mutagenic and notcytotoxic.
There are no in vivo mutagenicity studies for the aromatic sulphonic acids, but there are two in vivo mouse micronucleusstudies for the related hydrotropes – sodium cumene sulphonate (CAS 28348-53-0) (Sasol, 1992) and calcium xylene sulphonate (CAS 28088-63-3) (Ruetgers-Nease, 1994). Both are GLP-compliant Guideline mouse micronucleus studies with full documentation. The Sasol study was an oral dose of 4467 mg/kg bw and the Ruetgers-Nease study was an IP injection exposure of up to 580 mg/kg bw. Both studies conclude the test substances were not mutagenic in these assays.
Short description of key information:
Negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
All study results are negative.
No classification for mutagenicity is warranted under 67/548/EEC or Regulation 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
