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Administrative data

Key value for chemical safety assessment

Additional information

p-Phenylenediamine hydrochloride will dissociate in situ, to the chloride ion and its corresponding cation. p-Phenylenediamine will also dissociate in situ to form the corresponding cation. In view of the species being the same regardless of whether the test substance is in its salt form or not, p-phenylenediamine hydrochloride is therefore representative of the substance.

 

The test substance (tested as the hydrochloride) was studied in 3 in vitro mutagenicity assays. It was mutagenic in Salmonella typhimurium strain TA98 (in the presence of exogenous metabolic activation), but was negative in strains TA98 (in the absence of metabolic activation) and TA100, TA1535, TA1537, and TA102 (in the presence and absence of exogenous metabolic activation) when tested at concentrations up to 5000 µg/plate. The test substance (tested as the hydrochloride) induced micronuclei in cultured human peripheral blood lymphocytes (in the presence and absence of metabolic activation) when tested at concentrations up to 2000 µg/L following 48-hour PHA stimulation, but was not mutagenic in a mouse lymphoma assay with L5178Y cells, both in the presence and absence of metabolic activation at concentrations up to 1000 µg/L.

 

The test substance was non-genotoxic in an in vivo unscheduled DNA synthesis assay in rat hepatocytes and an in vivo rat micronucleus assay at doses up to 100 mg/kg (the maximal tolerated dose). 


Short description of key information:
in vitro (mutagenic effects - bacterial) - Ames assay (OECD 471) - mutagenic in TA98 with activation; not mutagenic in TA98 without activation, TA1535, TA1537, and TA102 (tested as the hydrochloride)
in vitro (mutagenic effects - mammalian) - Mouse lymphoma assay (equivalent to OECD 476) - not mutagenic (tested as the hydrochloride)
in vitro (chromosome aberrations - mammalian) - Micronucleus assay in human peripheral blood lymphocytes (equivalent to draft OECD 487) - mutagenic (tested as the hydrochloride)

in vivo (clastogenic effects - mammalian) - Rat micronucleus assay (OECD 474) - not mutagenic at any dose level tested
in vivo (DNA repair - mammalian) - Rat UDS (OECD 486) - not mutagenic at any dose level tested

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance did not produce mutagenicity when tested in vitro tests (as the hydrochloride) or in vivo tests (as the test substance) for evaluation of mutagenicity in cell culture or laboratory animals. The substance does not need to be classified for mutagenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.