Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.In Ames assay of genetic toxicity study to Salmonella typhimurium which is treated withtest chemical .The test performed in the presence of Aroclor-induced rat liver microsomalS-9cell fraction to observe the mutagenic effect oftest chemical.Non-mutagenic effects were known with S 9 metabolic activation toSalmonella typhimurium when treated with testchemical .Hence the test substance cannot be classified as gene mutant in vitro

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Ames mutagenicity test was conducted for test chemical to evaluate its gene toxic effects when exposed to Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 with dose concentration of 100-10000 µg/plate in plate incorporation assay. Based on the preliminary study conducted, the test compound was used at a five dose level from 100- 10000 µg/plate. Concurrent solvent and positive control chemicals were used in the study. For a test article to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test chemical. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment. However, test chemical did not show a dose dependent increase in the number of revertants. On the basis of results noted, test chemical failed to induce mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 both in the presence and absence of S9 activation system and hence is not likely to be a gene mutant in vitro.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Link to relevant study records

Reference

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 for the target chemical is summarized based on the structurally similar read across chemicals

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:

WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

- Name of test material: Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine
- Molecular formula: C11H23N7O3S
- Molecular weight: 333.41 g/mol
- Smiles notation: C=O_CC1CCC(S(N)(=O)=O)CC1_Nc1nc(N)nc(N)n1
- Substance type: Organic
- Physical state: Solid

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium, other:

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with

Metabolic activation system:

S9 from Aroclor-induced rat liver microsomal S-9 cell fraction

Test concentrations with justification for top dose:

1.Not specified
2.10-10000 µg/plate

Vehicle / solvent:

1.Not specified
2.Not specified

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Details on test system and experimental conditions:

1.Not specified
2.Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period:48-h

Rationale for test conditions:

Not specified

Evaluation criteria:

1.Not specified
2.Histidine revertent colonies were observed.

Statistics:

1.Not specified
1.Not specified

Species / strain:

S. typhimurium, other:

Metabolic activation:

with

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

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538

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 effect were observed

Conclusions:

Gene mutation toxicity study for Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine ( 97808-67-8) as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.

Executive summary:

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.In Ames assay of genetic toxicity study to Salmonella typhimurium which is treated withtest chemical .The test performed in the presence of Aroclor-induced rat liver microsomalS-9cell fraction to observe the mutagenic effect oftest chemical.Non-mutagenic effects were known with S 9 metabolic activation toSalmonella typhimurium when treated with testchemical .Hence the test substance cannot be classified as gene mutant in vitro

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Ames mutagenicity test was conducted for test chemical to evaluate its gene toxic effects when exposed to Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 with dose concentration of 100-10000 µg/plate in plate incorporation assay. Based on the preliminary study conducted, the test compound was used at a five dose level from 100- 10000 µg/plate. Concurrent solvent and positive control chemicals were used in the study. For a test article to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test chemical. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment. However, test chemical did not show a dose dependent increase in the number of revertants. On the basis of results noted, test chemical failed to induce mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 both in the presence and absence of S9 activation system and hence is not likely to be a gene mutant in vitro.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a 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

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.In Ames assay of genetic toxicity study to Salmonella typhimurium which is treated withtest chemical .The test performed in the presence of Aroclor-induced rat liver microsomalS-9cell fraction to observe the mutagenic effect oftest chemical.Non-mutagenic effects were known with S 9 metabolic activation toSalmonella typhimurium when treated with testchemical .Hence the test substance cannot be classified as gene mutant in vitro

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Ames mutagenicity test was conducted for test chemical to evaluate its gene toxic effects when exposed to Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 with dose concentration of 100-10000 µg/plate in plate incorporation assay. Based on the preliminary study conducted, the test compound was used at a five dose level from 100- 10000 µg/plate. Concurrent solvent and positive control chemicals were used in the study. For a test article to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test chemical. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment. However, test chemical did not show a dose dependent increase in the number of revertants. On the basis of results noted, test chemical failed to induce mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 both in the presence and absence of S9 activation system and hence is not likely to be a gene mutant in vitro.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (97808-67-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for target substance Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine ( 97808-67-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.