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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-815-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with full documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- 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:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Ethylmethanesulfonate without S9 and cyclophosphamide with S9
- Remarks:
- solvent was xylene
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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.
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.
