[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)-1-naphthalenyl)methylene)- 2,5-cyclohexadien-1-ylidene)-N-methyl-, acetate (1:1). The study assumed the use of Salmonella typhimurium strainsTA 1535, TA 1537, TA 98, TA 100 and TA 102 with S9 metabolic activation system. Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)-1-naphthalenyl)methylene) -2,5- cyclohexadien-1- ylidene)- N-methyl-, acetate (1:1) was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

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:

Prediction model based estimation and data from read across chemicals was reviewed to determine the mutagenic nature of Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)-1-naphthalenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, acetate (1:1). The studies are summarized as below:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)-1-naphthalenyl)methylene)-2,5 -cyclohexadien-1-ylidene)-N-methyl-, acetate (1:1). The study assumed the use of Salmonella typhimurium strainsTA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without S9 metabolic activation system. Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)-1-naphthalenyl)methylene)-2,5- cyclohexadien-1- ylidene)- N-methyl-, acetate (1:1) was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Gene mutation toxicity study was performed by Janik-Speichowicz et al (International Journal of Occupational Medicine and Environmental Health, 1997) to determine the mutagenic nature of 90 -100% structurally similar read across chemical Basic blue 26 (RA CAS no 2580 -56 -5). The study was performed using Salmonella typhimurium strains TA97a, TA98, TA100 and TA102 with and without S9 metabolic activation system. The test chemical was dissolved in sterilized distilled water and used at dose levels of 0, 1, 10, 100 or 500µg/plate. Concurrent spontaneous revertants and positive controls were also included in the study. The plates were incubated for 48 hrs and the plates were observed for 2-fold increase in the number of revertants per plate. Basic blue 26 did not induce gene mutation in Salmonella typhimurium strainsTA97a, TA98, TA100 and TA102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Gene mutation toxicity study was performed by Sustainability Support Services (Europe) AB has letter of access (Report no 40M0795/89444 (1970) to determine the mutagenic nature of 90 -100% structurally similar read across chemical Basic blue 26 (RA CAS no 2580 -56 -5) by standard plate method .Therefore it is acceptable to take analogous information. N-(4-{(4-anilino-1-naphthyl)[4-(dimethylamino)phenyl] methylene}cyclohexa-2,5-dien-1-ylidene)-N-methy.( 2580-56-5)was assessed for its possible  mutagenic potential by standard plate method. For this purpose Bacterial reverse mutation assay was performed according to guideline OECD 471.The test material was exposed to Salmonella Typhimurium TA 1535,TA1537,TA98 and TA 100 at the concentration of 4 ug - 500 ug/plate in the presence and absence of metabolic activation. Cytotoxicity was also observed. No mutagenic effect was observed. Therefore N-(4-{(4-anilino-1-naphthyl)[4-(dimethylamino)phenyl]methylene} cyclohexa-2,5-dien-1-ylidene)-N-methy was considered to be non mutagenic in Salmonella Typhimurium TA 1535,TA1537,TA98 and TA 100 by standard plate method. Hence the substance cannot be classified as gene mutant in vitro.

Gene mutation toxicity study was performed by Sustainability Support Services (Europe) AB has letter of access (Report no 40M0795/89444 (1970) to determine the mutagenic nature of 90 -100% structurally similar read across chemical Basic blue 26 (RA CAS no 2580 -56 -5) bypreincubation metod. N-(4-{(4-anilino-1-naphthyl)[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methy.( 2580-56-5)was assessed for its possible mutagenic potential by Preincubation method. For this purpose Bacterial reverse mutation assay was performed according to guideline OECD 471.The test material was exposed to Salmonella Typhimurium TA 1535,TA1537,TA98 and TA 100 at the concentration of 4 ug - 500 ug/plate in the presence and absence of metabolic activation. Cytotoxicity was also observed. No mutagenic effect was observed. Therefore N-(4-{(4-anilino-1-naphthyl)[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methy was considered to be non mutagenic in Salmonella Typhimurium TA 1535,TA1537,TA98 and TA 100 by Preincubation method. Hence the substance cannot be classified as gene mutant in vitro.

 

In a study for another read across chemical, Gene mutation toxicity study was performed by Chung et al (Applied and Environmental Microbiology, 1981) to determine the mutagenic nature 50 -60% structurally and functionally similar read across chemical of methyl violet 2B (RA CAS no 8004 -87 -3, IUPAC name: Basic violet 1). The study was performed by the standard plate incorporation assay and the preincubation method using Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 metabolic activation system. Also, the liquid preincubation assays were timed for 30 min at 37°C in a Dri-block. The test chemical was dissolved in DMSO and upto a maximum nontoxic dose of 10µg/plate. Concurrent solvent and positive controls were also included in the study.Methyl violet 2B did not induce gene mutation in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

 

Based on the data available for the target chemical and its read across, Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino) -1-naphthalenyl)methylene) -2,5-cyclohexadien-1-ylidene)-N-methyl-, acetate (1:1) does not exhibit gene mutation in vitro. Hence it is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Based on the data available for the target chemical and its read across, Methanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino) -1-naphthalenyl)methylene) -2,5-cyclohexadien-1-ylidene)-N-methyl-, acetate (1:1) does not exhibit gene mutation in vitro. Hence it is not likely to classify as a gene mutant in vitro.