Registration Dossier
Registration Dossier
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EC number: 205-855-5 | CAS number: 156-43-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Weight of evidence:
1.- Experimental result from a publication. The mutagenic potency of the analgetic bucetin was investigated according to the method of Ames et al., with and without metabolic activation. Since p-phenetidine has been reported in a HPLC study to be a metabolite of bucetin, its mutagenicity has also been studied. The test substance was positive for mutagenic effects in cultures with metabolic activation and negative without metabolic activation.
2.- Experimental result from a publication, according to modified Ames gradient plate test. Salmonella typhimurium G46, TA1535, TA100, C3076, TA1537, D3052, TA1538, and TA98 and Escherichia coli WP2 and WP2uvrA-, with and without metabolic activation. It is concluded that p-phenetidine was not mutagenic in the bacterial mutation assay.
3.- Experimental result from a publication, according to OECD guideline 471. Salmonella typhimurium TA 100, TA98, TA97, TA 102, with and without metabolic activation. Positive controls were used. Phenetidine resulted to be not mutagenic.
4.- Experimental result from a publication, according to OECD guideline 471. Salmonella typhimutium TA98 and TA100, with and without metabolic activation. It is concluded that phenetidine was mutagenic.
5.- Experimental result from a publication, according to OECD guideline 471. Salmonella typhimurium TA 98, wit metabolic activation. It is concluded that p-phenetidine is not mutagenic, and quercetin does not alter the mutagenicity of this compound.
Short description of key information:
Genetic toxicity in vitro: Weight of evidence: results from different independent sources. Some of them leading to the conclusion that the substance is mutagenic.
The substance is included in Table 3 of Annex VI of CLP Regulation (harmonised classification and labelling) and classified as:
Germ cell mutagenicity Category 2.
Endpoint Conclusion:
Justification for classification or non-classification
The substance is included in Table 3 of Annex VI of CLP Regulation (harmonised classification and labelling) and classified as:
Germ cell mutagenicity Category 2.
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