Reaction mass of 4-hydroxybenzene-1,3-disulphonic acid and 4-hydroxybenzenesulphonic acid and sulphuric acid and water

Genetic toxicity: in vitro

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

p-Toluolsulfonsaure

IUPAC Name:

p-Toluolsulfonsaure

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.