Registration Dossier
Registration Dossier
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EC number: 224-756-8 | CAS number: 4477-28-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
AMES test: positive
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
No in vivo genetic toxicity studies are available for 4-anilinobenzenediazonium hydrogen sulphate.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test item4-anilinobenzenediazonium hydrogen sulphate was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli according to OECD TG 471. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with Phenobarbital and 5,6-benzoflavone.The test item 4-anilinobenzenediazonium hydrogen sulphate induces reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism in all strains with the exception of TA1535.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) a mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). The term ‘mutagenic’ and ‘mutagen’ will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms. Considering the positive result of AMES test combining with QSAR alerts for mutagenicity due to the high reactivity of diazonium salt (radical mechanism and SN2 mechanism), 4-anilinobenzenediazonium hydrogen sulphate is classified on precautionary purpose H341 (muta. cat.2- Suspected of causing genetic defect) according to the CLP Regulation (EC n.1272/2008).
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