tert-butyl 3-oxobutanoate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

tert-Butyl 3-oxobutanoate does not exhibit gene toxicity in in the presence and absence of metabolic activation. Hence the substance cannot be classified as genetox 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

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:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

WoE report is based on two in vitro toxicity studies on rats1. Genotoxicity was performed to determine the mutagenic nature of test chemical 2.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium, other: TA98, 100, 1535, 1537 and 1538

Remarks:

1

Details on mammalian cell type (if applicable):

not specified

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

other: Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 and E. coli WP2 uvr A pKM 101

Remarks:

2.

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:

liver S9 mix produced from rats pretreated with Aroclor 1254

Test concentrations with justification for top dose:

2. Maximum concentration tested was 5000 ug/plate

Vehicle / solvent:

2. DMSO was used as a vehicle

Untreated negative controls:

not specified

Remarks:

1

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

other: 2-aminoanthracene, ICR-191

Details on test system and experimental conditions:

2. NUMBER OF REPLICATIONS: Triplicate

Evaluation criteria:

1. Revertants / plate (less than doubling)

Statistics:

2. Mean number of revertants and standard deviations were calculated. Various criteria were established to constitute a valid assay and a positive response was indicated by a 2-3 fold increase in mean revertant number dependent on the bacterial tester strain.

Species / strain:

S. typhimurium, other: 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:

other: Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 and E. coli WP2 uvr A pKM 101

Remarks:

2.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

>5000 ug/plate (no evidence of cytotoxicity was seen)

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: not specified

Conclusions:

tert-Butyl 3-oxobutanoate does not exhibit gene toxicity in in the presence and absence of metabolic activation.

Executive summary:

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical N-[4-[(9, 10-dihydro-4-hydroxy-9, 10-dioxo-1-anthryl) amino] phenyl] acetamide (CAS no 67905-17-3).The studies are as mentioned below:

Ames Test:

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed using S. typhimurium strains 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) in S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 and E. coli WP2 uvr A pKM 101 both in the presence and absence of Aroclor 1254-induced SD rat liver S9. The test material did not induce gene mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 with and without Aroclor 1254-induced SD rat liver S9. 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, tert-Butyl 3-oxobutanoate does not exhibit gene toxicity in in the presence and absence of metabolic activation. Hence the substance cannot be classified as genetox 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 N-[4-[(9, 10-dihydro-4-hydroxy-9, 10-dioxo-1-anthryl) amino] phenyl] acetamide (CAS no 67905-17-3).The studies are as mentioned below:

Ames Test:

AMES test was performed to determine the mutagenic nature of test chemical. The study was performed using S. typhimurium strains 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) in S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 and E. coli WP2 uvr A pKM 101 both in the presence and absence of Aroclor 1254-induced SD rat liver S9. The test material did not induce gene mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 1537, TA 98, TA 1535 and TA 100 with and without Aroclor 1254-induced SD rat liver S9. 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, tert-Butyl 3-oxobutanoate 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, tert-Butyl 3-oxobutanoate does not exhibit gene toxicity in in the presence and absence of metabolic activation. Hence the substance cannot be classified as genetox in vitro.