Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

1,2 -dichloro-4 -nitrobenzene, tested in the Ames test according to OECD TG 471 with and without a metabolic activation system and up to cytotoxicity, yielded a positive result (JETOC 2005) 1,2 -dichloro-4 -nitrobenzene technical grade was tested in the CHO/HPRT Mammalian cell forward gene mutation assay and yielded negative result (Monsonto Co 1986). Thus ist could be shown that the positive result in an bacterial mutation test could not be confirmed in an gene mutation test using a mammalian cell system.

1,2-dichloro-4-nitrobenzene shall be registrated according to the Regulation (EC) 1907/2008 (REACH) Article 18 (transported isolated intermediate) and according to ANNEXVII no studies on chromosome aberration are required or need to be considered.


Short description of key information:
1,2 -dichloro-4 -nitrobenzene, tested in the Ames test according to OECD TG 471 with and without a metabolic activation system and up to cytotoxicity, yielded a positive result (JETOC 2005) 1,2 -dichloro-4 -nitrobenzene technical grade was tested in the CHO/HPRT Mammalian cell forward gene mutation assay and yielded negative result (Monsonto Co 1986).

1,2-Dichloro-4-nitrobenzene induced chromosomal aberations in CHL/IU cells when tested according to the respective guideline up to cytotoxicity (JETOC 2005).
1,2-dichloro-4 -nitrobenzene technical grade showed no clastogenic activity in vivo in a chromosomal aberration test in bone marrow of rats (Monsanto Co 1983)

Endpoint Conclusion:

Justification for classification or non-classification

Based on the above discussed experimental results, there is no reason for classification