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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1978 - May 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to a method similar to OECD471 but with some deviations. The study was performed pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
- test performed on single plates instead of triplo.
- no independent repeat to confirm negative results
- with this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. For the current substance this is not considered critical.
GLP compliance:
no
Remarks:
pre-GLP
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Identification: Para-Toluene Sulphone Amide
Date Received: March 27, 1978
Physical description: White powder

Method

Target gene:
histidine operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
1, 10, 100, 500, 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: See "any other information on...."
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: not applicable
- Exposure duration: 48 hours (bacteria), 3-5 days (yeast)
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable

SELECTION AGENT (mutation assays): histidine
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable

NUMBER OF REPLICATIONS: duplicate

NUMBER OF CELLS EVALUATED: all colonies were counted

DETERMINATION OF CYTOTOXICITY
- Method: no data

OTHER EXAMINATIONS:
- Determination of polyploidy: not applicable
- Determination of endoreplication: not applicable
- Other: not applicable

OTHER: not applicable
Evaluation criteria:
Strains TA-1535, TA-1537, and TA-1538
If the solvent control value is within the normal range, a chemical that produces a positive aose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.

Strains TA-98, TA-100, and D4
If the solvent control value i s within the normal range, a chemical that produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control value for TA-100 and 2-3 times the solvent control value for strains TA-98 and D4 is considered to be
mutagenic. For these strains , the dose-response increase should start at approximately the solvent control value.

Reproducibility
If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the initial positive test data lose significance.
Statistics:
None

Results and discussion

Test results
Species / strain:
other: all
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Highest doses selected to show slight toxicity as determined by subjective criteria.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test compound Para-Toluene Sulphone did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.
Executive summary:

The test compound was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces indicator organisms. The compound was tested with and without metabolic activation prepared from Aroclor induced rats. The following results were obtained: The compound was tested over a series of concentrations such that there was either quantitative or qualitative evidence of some chemically induced physiological effect at the highest dose level. The low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this compound was from 1.0 µg to 1000 µg per plate. The results of the tests conducted on the compound in the absence of a metabolic activation system were all negative. The results of the tests conducted on the compound in the presence of a rat liver activation system were all negative. The test compound para-Toluene Sulphone did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.