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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

AMES Assay

Test substance did not induce a reproducible, dose-related increase in his+ revertants over the corresponding solvent in the S. typhimurium tester strains TA1535, TA1537, TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is negative for mutation in vitro.

In vitro Mammalian gene mutation assay

Test chemical was evaluated for its mutagenic potential in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay.. The test results were considered to be negative in the presence and absence of S9 mix.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
Weight of evidence prepared from various publication mention below
1,Bacterial reverse mutation assay was performed to evaluate the mutagenic nature of the test compound.
2.Evaluate mutagenicity of test chemical by the FMN preincubation modification of the Salmonella assay.Evaluate mutagenicity of test chemical by the FMN preincubation modification of the Salmonella assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other:
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared
Test concentrations with justification for top dose:
1,0, 100, 333, 1000, 3333 or 10000 µg/plate
2,33, 100, 333, 1000 and 3333 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: The chemical was soluble and stable in water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Water
True negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-Aminoanthracene (All strains; With S9)
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Trypan blue (228 /µg/plate)
Details on test system and experimental conditions:
1,METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:

OTHER: No data available

2,Details on test system and conditions
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 hr
Rationale for test conditions:
No data
Evaluation criteria:
An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of "+W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.

The chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.

It chemical was considered to be questionable (?) if a reproducible increase of his+ revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials.
Statistics:
Mean and Standard error of mean (SEM)
Species / strain:
S. typhimurium, other: TA98, TA100, TA1535, and TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effects were observed.
Conclusions:
Test substance did not induce a reproducible, dose-related increase in his+ revertants over the corresponding solvent in the S. typhimurium tester strains TA1535, TA1537, TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is negative for mutation in vitro.
Executive summary:

Data for the various test chemicals was reviewed to determine the mutagenic nature of sodium 4-(2-methylprop-2-en-1-yl)benzenesulfonate (1208-67-9). The studies are as mentioned below:

AMES test

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test compound test substance using S. typhimurium tester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in water and was used at a dosage level of 0, 100, 333, 1000, 3333 or 10000 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. Test substance did not induce a reproducible, dose-related increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA1535, TA1537, TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is negative for mutation in vitro.

 

Gene mutation toxicity study was performed to evaluate mutagenicity of test substance by the standard plate-incorporation assay.The study was performed using S.typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100. All strain were tested at dose levels of 0, 3333, 1000, 6666 and 10000 µg/plate both with and without metabolic activation (Aroclor 1254-induced male Fischer). Positive control and solvent control as used. There was no dose-related increase in the number of revertants above spontaneous solvent controls, with a 2-fold increase for strains TA1535, TA1538, TA98 and TA100, and a 3-fold increase for TA1537. Hence, the test substance is considered to be not mutagenic in Salmonella typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100 with and without metabolic activation.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
Weight of evidence prepared from various publication mention below
To evaluate the mutagenic potential of test chemical in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay.
GLP compliance:
not specified
Type of assay:
other: In vitro Mammalian cell gene mutation assay.
Target gene:
TK locus
Species / strain / cell type:
mouse lymphoma L5178Y cells
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
mouse lymphoma L5178Y cells
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction from non-induced Syrian golden hamsters was used
Test concentrations with justification for top dose:
1,10, 20, 40, 80, 160 and 320 μg/ml, without and with S9-mix.
2,+S9;100-10000 µg/PLATE
-S9; 125-5000 µg/PLATE
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: culture medium
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
culture medium
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
experiment 1: 4 h both without and with S9-mix; expression period
72 h and a selection period of 10-15 days.
experiment 2: 24 h without S9-mix; expression period 48 h and a selection period of 10-15 days.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
To discriminate between large (indicative for mutagenic effects) and small colonies (indicative for a clastogenic effect) colony sizing was performed.
An increased occurrence of small colonies indicated by a low large/small colonies ratio (<4) was associated with clastogenic effects and/or chromosomal aberrations.
Statistics:
Not specified
Species / strain:
mouse lymphoma L5178Y cells
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:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic effects were observed
Conclusions:
Test chemical was evaluated for its mutagenic potential in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay.. The test results were considered to be negative in the presence and absence of S9 mix.
Executive summary:

Data for the various test chemicals was reviewed to determine the mutagenic nature of sodium 4-(2-methylprop-2-en-1-yl)benzenesulfonate (1208-67-9). The studies are as mentioned below:

Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed as per OECD 476.The test substance in Mouse Lymphoma cell line L5178Y. The test material was exposed at the concentration of 10, 20, 40, 80, 160 and 320 μg/ml in the presence and absence of S9 mix. No mutagenic effect were observed in Mouse Lymphoma cell line L5178Y ,both in the presence and absence of S9.Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed in Mouse Lymphoma cell line L5178Y. The test material was exposed to different concentration of mention below

+S9;100-10000 µg/PLATE

-S9; 125-5000 µg/PLATE

 

 No mutagenic effect were observed in Mouse Lymphoma cell line L5178Y ,both in the presence and absence of S9.Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data for the various test chemicals was reviewed to determine the mutagenic nature of sodium 4-(2-methylprop-2-en-1-yl)benzenesulfonate (1208-67-9). The studies are as mentioned below:

AMES test

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test compound test substance using S. typhimurium tester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in water and was used at a dosage level of 0, 100, 333, 1000, 3333 or 10000 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. Test substance did not induce a reproducible, dose-related increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA1535, TA1537, TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is negative for mutation in vitro.

 

Gene mutation toxicity study was performed to evaluate mutagenicity of test substance by the standard plate-incorporation assay.The study was performed using S.typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100. All strain were tested at dose levels of 0, 3333, 1000, 6666 and 10000 µg/plate both with and without metabolic activation (Aroclor 1254-induced male Fischer). Positive control and solvent control as used. There was no dose-related increase in the number of revertants above spontaneous solvent controls, with a 2-fold increase for strains TA1535, TA1538, TA98 and TA100, and a 3-fold increase for TA1537. Hence, the test substance is considered to be not mutagenic in Salmonella typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100 with and without metabolic activation.

In vitro Mammalian gene mutation assay

Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed as per OECD 476.The test substance in Mouse Lymphoma cell line L5178Y. The test material was exposed at the concentration of 10, 20, 40, 80, 160 and 320 μg/ml in the presence and absence of S9 mix. No mutagenic effect were observed in Mouse Lymphoma cell line L5178Y ,both in the presence and absence of S9.Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed in Mouse Lymphoma cell line L5178Y. The test material was exposed to different concentration of mention below

+S9;100-10000 µg/PLATE

-S9; 125-5000 µg/PLATE

 

 No mutagenic effect were observed in Mouse Lymphoma cell line L5178Y ,both in the presence and absence of S9.Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

 

Based on the data summarized, sodium 4-(2-methylprop-2-en-1-yl)benzenesulfonate (1208-67-9). did not induce gene mutation .Hence it is not likely to be mutagenic in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria the test chemical sodium 4-(2-methylprop-2-en-1-yl)benzenesulfonate (1208-67-9). did not induce gene mutation .Hence it is not likely to be mutagenic in vitro.