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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Link to relevant study records
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
October 10-12, 1988
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with full documentation
according to guideline
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
in vitro mammalian chromosome aberration test
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 fraction following Aroclor 1254 exposure
Test concentrations with justification for top dose:
200, 600, 1902 micrograms per milliliter
Untreated negative controls:
Negative solvent / vehicle controls:
True negative controls:
Positive controls:
Positive control substance:
other: Ethylmethanesulfonate without S9 and cyclophosphamide with S9
solvent was xylene
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
Untreated negative controls validity:
Positive controls validity:
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'.

Mitotic Index: Concentration related plating efficiency was established in 1000 cells from each of two slides per test group. No influence on mitotic index was observed.

The precipitation concentration was > 1902 ug/mL

Interpretation of results (migrated information):

The test substance does not induce chromosome mutations (aberrations) in V79 Chinese Hamster cells. The substance is neither mutagenic nor cytotoxic under the conditions of the study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Sulphuric acid, the main component of the multiconstituent substanceis not classified as mutagen or carcinogenic. No study on sulphuric acid reveal any alert for genotoxicity

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.

No concern is arised by the disulphonic acid

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.