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Administrative data

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:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
equivalent or similar to
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
Test material information:
Composition 1
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:
S. typhimurium TA 1538
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain 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.)
Species / strain:
S. typhimurium TA 1538
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain 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:
1,10 mg/ ml
2,5 mg/mL
Vehicle:
1,Deionised water
2,Deionised water
Negative controls:
yes
Solvent controls:
yes
Remarks:
Deionised water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Rimmel Mahogany Silk 2-acetylaminofluorene
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and 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:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effect were observed
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: No mutagenic effct 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.