Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes

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 Aluminum,

2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4).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 a Mutagenicity test, the mutagenic effect of test chemical was evaluated in Salmonella typhimurium strain TA1538 utilizing a Fluctuation test. The bacteria were exposed to the test compound at the concentration of 1 or 10 mg /ml in presence or absence of metabolic activation. At the end of the study, the tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the colour. In this case, the presence of viable prototrophic revertants was verified by streaking loop full from each tube onto non-supplemented agar. As seen by the results, no mutagenic effects of Red 2G were found at 1 or 10 mg/ml in the absence or presence of metabolic activation. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

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. The Salmonella/mammalian microsome test was performed to determine the mutagenic nature of test chemical in vitro. Ames assay was performed using Fluctuation test .The test chemical at a concentration of 5 mg/mL in liquid medium for 72-96 hrs. The tester strains used were Salmonella typhimurium TA 1538 both in the presence and absence of metabolic activation system. The assay was performed for each bacterium in three separate experiments. The given test material failed to induce genotoxicity in the bacteria Salmonella typhimurium TA 1538 and hence is negative for gene mutation in vitro. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4)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:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

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: Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium TA 1538

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 and without

Metabolic activation system:

S9 mix from Calcium precipitated microsome from rat liver (Male, 5-week old Sprague-Dawley rats were supplied with 0.1% w/v sodium pentobarbitone and 2% w/v D-glucose in their drinking water for one week.)

Test concentrations with justification for top dose:

1,10 mg/ ml
2,5 mg/mL

Vehicle / solvent:

1,Deionised water
2,Deionised water

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

Deionised water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Rimmel Mahogany Silk 2-acetylaminofluorene

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Details on test system and experimental conditions:

1,Details on test system and conditions
Fluctuation test without microsomal activation
The fluctuation test was performed according to the method of Green and
Muriel with the following modifications. A single colony from a plate of each of the bacterial strains (S. typhimurium TA1538) was inoculated into 10 ml of the appropriate growth medium and incubated overnight at 37°C with shaking. The mutation media were as follows: (a) TA1538: solution SA, 1.20.5 ml; solution SB, 4.5 ml; solution SC, 25 pl; solution SD, 25 pl. Sub-lethal concentrations of each test agent were prepared in the mutation media. 30 µl of inoculum culture were pipetted into this mixture, which was then dispensed in 2-ml aliquots into 50 test tubes (75 × 12 mm, rimless). The number of turbid tubes was scored after 72 h incubation at 37 ° C.
Fluctuation test with microsomal activation
0.1 ml of overnight TA1538 culture was pipetted into 0.9 ml solution SA (plus 9 mg /m1 D-glucose, 17 µg /ml L-histidine and 0.9 µg /ml D-biotin). The mutation media were as follows: (a) WP2uvrA: solution F (plus D-glucose, L-tryptophan and bacteria), 1 ml; calcium-precipitated microsome, 1 ml; 8 mg/ ml G-6-P, 0.25 ml; 5 units /ml G-6-PDH, 0.1 ml; water or water soluble test agent, 0.5 ml; (b) TA1538: as Green et al. (DMSO-soluble agents were added to the mutation media in 5-pl volumes).The mixture was dispensed in 100-µl aliquots into each of 50 test tubes and incubated for 24 h at 37°C. 2 ml solution F (plus 0.4% w/v D-glucose) was dispensed into each of the TA1538 tubes. These were then incubated for 72 hour at 37°C before scoring for turbidity.

2,Details on test system and conditions
METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: No data available
- Exposure duration: 72-96 hrs
- Expression time (cells in growth medium): 72-96 hrs
- Selection time (if incubation with a selection agent): No data available

Rationale for test conditions:

Not specified

Evaluation criteria:

1,The tubes were scored for turbidity.
2,The test material was considered positive only if it resulted in significant more turbid tubes in a treated series when compared with an untreated set of tubes

Statistics:

1,Not specified
2,Chi square test

Species / strain:

S. typhimurium TA 1538

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 TA 1538

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 Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4)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 Aluminum,

2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4).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 a Mutagenicity test, the mutagenic effect of test chemical was evaluated in Salmonella typhimurium strain TA1538 utilizing a Fluctuation test. The bacteria were exposed to the test compound at the concentration of 1 or 10 mg /ml in presence or absence of metabolic activation. At the end of the study, the tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the colour. In this case, the presence of viable prototrophic revertants was verified by streaking loop full from each tube onto non-supplemented agar. As seen by the results, no mutagenic effects of Red 2G were found at 1 or 10 mg/ml in the absence or presence of metabolic activation. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

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. The Salmonella/mammalian microsome test was performed to determine the mutagenic nature of test chemical in vitro. Ames assay was performed using Fluctuation test .The test chemical at a concentration of 5 mg/mL in liquid medium for 72-96 hrs. The tester strains used were Salmonella typhimurium TA 1538 both in the presence and absence of metabolic activation system. The assay was performed for each bacterium in three separate experiments. The given test material failed to induce genotoxicity in the bacteria Salmonella typhimurium TA 1538 and hence is negative for gene mutation in vitro. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene) -1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4)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 Aluminum,

2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4).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 a Mutagenicity test, the mutagenic effect of test chemical was evaluated in Salmonella typhimurium strain TA1538 utilizing a Fluctuation test. The bacteria were exposed to the test compound at the concentration of 1 or 10 mg /ml in presence or absence of metabolic activation. At the end of the study, the tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the colour. In this case, the presence of viable prototrophic revertants was verified by streaking loop full from each tube onto non-supplemented agar. As seen by the results, no mutagenic effects of Red 2G were found at 1 or 10 mg/ml in the absence or presence of metabolic activation. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

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. The Salmonella/mammalian microsome test was performed to determine the mutagenic nature of test chemical in vitro. Ames assay was performed using Fluctuation test .The test chemical at a concentration of 5 mg/mL in liquid medium for 72-96 hrs. The tester strains used were Salmonella typhimurium TA 1538 both in the presence and absence of metabolic activation system. The assay was performed for each bacterium in three separate experiments. The given test material failed to induce genotoxicity in the bacteria Salmonella typhimurium TA 1538 and hence is negative for gene mutation in vitro. Hence, test chemical is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

 

 The data available for the target chemical based on its read across substance and applying weight of evidence Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4)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 Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes(94891-32-4)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.