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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed pre-GLP and according to a method similar to OECD471 but with some deviations: - Single plates were used instead of triplicate plates. - With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have. - 3 concentration tested at which no cytotoxicity was observed instead of 5.

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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
- Single plates were used instead of triplicate plates.
- With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have.
- 3 concentration tested at which no cytotoxicity was observed instead of 5
GLP compliance:
no
Remarks:
pre-GLP
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tosyl chloride
EC Number:
202-684-8
EC Name:
Tosyl chloride
Cas Number:
98-59-9
Molecular formula:
C7H7ClO2S
IUPAC Name:
4-methylbenzenesulfonyl chloride
Details on test material:
Identification: Para-Toluene Sulpho Chloride
Date Received: March 27, 1978
Physical Description: White crystals

No further data

Method

Target gene:
Histidine operon
Species / strainopen allclose all
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 1538 and TA 100
Species / strain / cell type:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
1.0, 10.0, 100.0, 500.0 and 1000.0 microgram/plate
Controls
Untreated negative controls:
yes
Remarks:
DMSO solvent
Negative solvent / vehicle controls:
yes
Remarks:
DMSO solvent
True negative controls:
no
Positive controls:
yes
Remarks:
depending to strain
Positive control substance:
2-nitrofluorene
ethylmethanesulphonate
other: Quinacrine mustard; Anthraceen

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
Saccharomyces cerevisiae
Remarks:
D4
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(except at 500 and 1000µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks:
There is no know positive compound that works wwith this strain in the activation plate assay.

Any other information on results incl. tables

The test compound exhibited toxicity with all the strains except D4 at 500 and 1000 ug per plate dose level. The results of the tests conducted on the compound in the presence and absence of a metabolic activation system were all negative.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: study is invalid no reliable conclusion can be drawn

Tosyl chloride was not mutagenic in the Ames Salmonella/microsome plate test with and without metabolic activation.
Executive summary:

The study was performed pre-GLP and according to a method similar to OECD 471 (plate incorporation). S. typhimurium TA 1535, TA 1537, TA 98, TA 1538 and TA 100 and Saccharomyces cerevisiae were exposed to 1.0, 10.0, 100.0, 500.0 and 1000.0 microgram/plate. The negative control was the solvent DMSO. The postitive control depended on the strain.

The study was performed with some deviations compared to OECD 471:

- Single plates were used instead of triplicate plates.

- With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have.

- 3 concentration tested at which no cytotoxicity was observed instead of 5.

The test compound exhibited toxicity with all the strains except D4 at 500 and 1000 ug per plate dose level. The results of the tests conducted on the compound in the presence and absence of a metabolic activation system were all negative.The authors concluded that the outcome of the study is negative.

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