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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 10-12, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with full documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-toluolsulfonsaure
- Molecular formula (if other than submission substance): C7H8O3S
- Molecular weight (if other than submission substance): 190.2
- Substance type: organic
- Physical state:crystallin powder
- Analytical purity: >98%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: GPAD 185
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: in the dark at 20C

Method

Species / strain
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
Controls
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

Results and discussion

Test results
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'.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.