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Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic activity of 1 -chloro-4-nitrobenzene was investigated in a bacterial gene mutation assay conducted similar to OECD-guideline 471. The preincubation assay was performed with Salmonella typhimurium TA98, TA 100, TA1535 and TA1537 both in presence and absence of a metabolic activator (induced rat and hamster liver S9 -mix) at 0.0, 30, 100, 300, 1000, 3000 µg and additionally in TA100 with and without S9 -mix at 0.0, 62.5, 250, 500, 1500, 2000 µg 1 -chloro-4 -nitrobenzene per plate.

The test compound induced mutations in presence of an metabolic activator (hamster liver S9 -mix stronger than with rat liver S9 -mix) in the strain TA100 up to 2.2 times higher than control (Harworth, 1983).

In additional studies which meet the criteria of today Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537 were used with and without S9 -mix 1 -chloro-4 -nitrobenzene showed mutagenic effects (NTP, 1993; Shimizu et al., 1983, Dupont, 1975, 1977).

A mouse lymphoma assay was performed comparable to the OECD guideline 476 with acceptable restrictions (no differentiation between small and large colonies) was performed. In the prsence of S9 -mix two trails were performed using doses between 42 - 350 µg/mL and 21 - 350 µg/mL and without metabolic activation concentrations between 25 - 600 µg/mL. In both cases 1 -chlor-4 -nitrobenzene induced positive response (Monsanto, 1983).

In HGPRT tests which were performed in Chinese Hamster Ovary (CHO) cells combarable to to OECD guideline 476 with acceptable restrictions, 1 -chloro-4 -nitrobenzene did not induce gene mutations (Monsanto, 1983 and Dupont, 1979).

1 -chloro-4 -nitrobenzene was also negative tested in UDS studies (Monsanto, 1984, 1985), but there was found an increase in Sister chromatid exchanges performed in Chinese Hamster Ovary cells in presence of metabolic activation (Galloway et al., 1987). In the same study chromosome aberration activity of 1 -chloro-4 -nitrobenzene was investigated comprarable to OECD guideline study 473 with acceptable restrictions. 1 -chloro-4 -nitrobenzene was tested positive with metabolic activation and weakly positive without metabolic activation (Galloway et al., 1987).

In in vivo studies a micronucleus assay in mouse bome marrow was performed according to OECD guideline 474. A single intraperitoneal application of 500 mg/kg body weight induced a positive effect (Herbold, Bayer AG, 1990). Also the activity of 1 -chloro-4 -nitrobenzene for sister chromatid exchanges in Chinese hamster bone marrow was tested positive (Herbold, Bayer AG, 1992).

Summarized all data together it can be concluded, that there is evidence of 1 -chloro-4 -nitrobenzene to induce genotoxicity in vitro and in vivo.

Short description of key information:
p-Chloronitrobenzene was found to be genotoxic.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Harmonised classification (Regulation 1272/2008):

DSD: Muta. Cat. 3, Xn, R68 Possible risk of irreversible effects.

GHS: Category 2 mutagen