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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.