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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Test chemical did not induce mutation in with and without S9 mix and hence it is not likely to classify as a gene mutant in vitro.

hence it is not likely to classify as a gene mutant in vitro.

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
Remarks:
Experimental data of read across substances
Justification for type of information:
Weight of evidence approach based on structurally similar chemicals
Reason / purpose for cross-reference:
exposure-related information
Reason / purpose for cross-reference:
exposure-related information
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
WoE report is based on two gene toxicity studies 1. and 2 Genotoxicity was performed to determine the mutagenic nature of test chemical
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: S. typhimurium strains TA98, 100, 1535, 1537 and 1538
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, TA97
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
not specified
Test concentrations with justification for top dose:
2. 10 mg/Platte
Vehicle / solvent:
not specified
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
not specified
Details on test system and experimental conditions:
not specified
Rationale for test conditions:
not specified
Evaluation criteria:
1. Revertants / plate (less than doubling)
Statistics:
not specified
Species / strain:
other: S.typhimurium strains TA98, 100, 1535, 1537 and 1538
Remarks:
1.
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
Species / strain:
S. typhimurium, other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, TA97
Remarks:
2.
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 mutation
Conclusions:
Test chemical did not induce mutation in with and without S9 mix and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed usingS. typhimuriumstrains TA98, 100, 1535, 1537 and 1538 both in the presence and absence of a metabolic activation system (liver S9 mix produced from rats pretreated with Aroclor 1254). The test material did not produce a statistically significant increase in the revertants / plate (less than doubling) thereby demonstrating no potential to induce gene mutations. Therefore, Test chemical did not induce revertants / plate (less than doubling) inS. typhimuriumstrains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA98, TA100, TA1535, TA1537 and TA97 both in the presence and absence of a metabolic activation system at 10 mg/Platte. The test material did not induce gene mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA98, TA100, TA1535, TA1537 and TA97 and hence it is not likely to classify as a gene mutant in vitro.

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
Remarks:
Experimental data of read across substances
Justification for type of information:
Weight of evidence approach based on structurally similar chemicals
Reason / purpose for cross-reference:
exposure-related information
Reason / purpose for cross-reference:
exposure-related information
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Genotoxicity was performed to determine the mutagenic nature of test chemical
GLP compliance:
not specified
Type of assay:
other: 1. Genotoxicity was performed to determine the mutagenic nature of test chemical 2. Chinese Hamster lung fibroplast cells, V79
Species / strain / cell type:
other: Cell line
Remarks:
1.
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with
Metabolic activation system:
liver S9 mix produced from rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
not specified
Vehicle / solvent:
not specified
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
not specified
Details on test system and experimental conditions:
not specified
Rationale for test conditions:
not specified
Evaluation criteria:
not specified
Statistics:
not specified
Species / strain:
other: cell line
Remarks:
1.
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:
Chinese hamster lung fibroblasts (V79)
Remarks:
2
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 mutation
Conclusions:
Test chemical did not induce mutation in with and without S9 mix and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

SCE-assay was performed to determine the mutagenic nature of test chemical. The study was perfomed using SCE cell both in the presence and absence of a S9 metabolic activation system (liver S9 mix produced from rats pretreated with Aroclor 1254). Highest test substance concentrations employed in this test were 0.1 and 0.3 mg/ml and exposure times were 5h and 2 h in the absence and presence of a metabolic activation system, respectively. Additionally, it was found that 2,4-pentanedione was considered genotoxic particularly in the absence of metabolic activation since the magnitude of SCE induction was lower when activation by S9 mix was included. Therefore, Test chemical did not induction in SCE with metabolic activation and produce induction without S9 mix and hence it is not likely to classify as a gene mutant in vitro.

Genotoxicity was performed to determine the mutagenic nature of test chemical. The study was performed using Chinese Hamster lung fibroplast cells, V79 absence of a S9 metabolic activation system. No inhibition of intracellular communication was observed in Chinese Hamster lung fibroplast cells, V79. Therefore, Test chemical did not induction in Chinese Hamster lung fibroplast cells, V79 without metabolic activation and hence it 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

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no 17852-98-1)The studies are as mentioned below:

Ames test:

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed usingS. typhimuriumstrains TA98, 100, 1535, 1537 and 1538 both in the presence and absence of a metabolic activation system (liver S9 mix produced from rats pretreated with Aroclor 1254). The test material did not produce a statistically significant increase in the revertants / plate (less than doubling) thereby demonstrating no potential to induce gene mutations. Therefore, Test chemical did not induce revertants / plate (less than doubling) inS. typhimuriumstrains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA98, TA100, TA1535, TA1537 and TA97 both in the presence and absence of a metabolic activation system at 10 mg/Platte. The test material did not induce gene mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA98, TA100, TA1535, TA1537 and TA97 and hence it is not likely to classify as a gene mutant in vitro.

Chromosome aberration:

SCE-assay was performed to determine the mutagenic nature of test chemical. The study was perfomed using SCE cell both in the presence and absence of a S9 metabolic activation system (liver S9 mix produced from rats pretreated with Aroclor 1254). Highest test substance concentrations employed in this test were 0.1 and 0.3 mg/ml and exposure times were 5h and 2 h in the absence and presence of a metabolic activation system, respectively. Additionally, it was found that 2,4-pentanedione was considered genotoxic particularly in the absence of metabolic activation since the magnitude of SCE induction was lower when activation by S9 mix was included. Therefore, Test chemical did not induction in SCE with metabolic activation and produce induction without S9 mix and hence it is not likely to classify as a gene mutant in vitro.

Genotoxicity was performed to determine the mutagenic nature of test chemical. The study was performed using Chinese Hamster lung fibroplast cells, V79 absence of a S9 metabolic activation system. No inhibition of intracellular communication was observed in Chinese Hamster lung fibroplast cells, V79. Therefore, Test chemical did not induction in Chinese Hamster lung fibroplast cells, V79 without metabolic activation and hence it is not likely to classify as a gene mutant in vitro.

Based on the data available from the test chemical and read across, N,N-Diethyl-3-oxobutyramide does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro. 

Justification for classification or non-classification

Based on the data available from the test chemical and read across, N,N-Diethyl-3-oxobutyramide does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro.