4,5-dichloro-2-nitroaniline

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 4,5-Dichloro-2-nitroaniline. The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with S9 metabolic activation system. 4,5-Dichloro-2-nitroaniline 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 for the target chemical and data from read across chemicals have been reviewed to determine the mutagenc nature of 4,5-Dichloro-2-nitroaniline. The studies are as summarized 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 4,5-Dichloro-2-nitroaniline. The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without S9 metabolic activation system. 4,5-Dichloro-2-nitroaniline 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 to determine the mutagenic nature of strcuturally and functionallly similar read across chemical o-Nitroaniline (RA CAS no 88 -74 -4; IUPAC name: 2- Nitroaniline). The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system using the standard plate protocol. The chemical was dissolved in p-dioxane as solvent and used at dose levels 0- 10 µmol/plate. The plates were incubated for 2 days and observed for the presence of colonies. o-Nitroanilinedid not induce mutation in Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

In a study by Zeiger et al (Environmental and Molecular Mutagenesis, 1982) for structurally and functionally similar read across chemical, gene mutation toxicity study was performed to determine the mutagenic nature of 2,4,6 trichloroaniline (RA CAS no 634 -93 -5). The study was performed using Salmonella typhimurium strains TA98, TA97, TA100 and TA1535 in the presence and absence of S9 metabolic activation system. The chemical was dissolved in DMSO as solvent and used at dose levels 0, 1, 3, 10, 33, 67, 100, 200, 333 or 667 µg/plate by the preincubation method. The doses were selected on the basis of preliminary dose range finding study and concurrent solvent and positive controls were included in the study. N-Acetyl-p-toluidine did not induce gene mutation in Salmonella typhimurium TA97, TA98, TA100, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Based on the data available for the target chemical and its read across, 4,5-Dichloro-2-nitroaniline does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for the target chemical and its read across, 4,5-Dichloro-2-nitroaniline (CAS no 6641 -64 -1) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.