Registration Dossier
Registration Dossier
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EC number: 692-721-8 | CAS number: 757251-39-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro
The mutagenic potential of AFP-Picolinmethylamid was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Herbold, 2007). Doses up to and including 2400 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect. Due to the weakness of this effect this range could nevertheless be used for assessment purposes.Evidence of mutagenic activity of AFP-Picolinmethylamid was seen. On Salmonella typhimurium TA 100 and TA 98, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found only with S9 mix. The lowest effective dose was 50 µg per plate for TA 100 and 300 µg per plate for TA 98. The Salmonella/microsome test thus showed AFP-Picolinmethylamid to have a mutagenic effect.
Genetic toxicity in vivo
Evaluation of the Micronucleus test data did not show any evidence for a mutagenic potential of AFP-Picolinmethylamid (BAY 74-2329) in male and female rats when administered intragastrically up to the toxic dose level of 500 mg/kg bw (Rothfuß and von Wedel, 2011). It is therefore concluded that AFP-Picolinmethylamid is non-mutagenic in the rat bone marrow Micronucleus test according to OECD TG 474.
Evaluation of the liver Comet Assay data obtained in the low dose study showed that treatment with AFP-Picolinmethylamid (BAY 74-2329) at doses up to 60 mg/kg did not produce any evidence for genotoxicity in the rat liver Comet Assay (Rothfuß and von Wedel, 2011). However, data obtained in the high dose liver Comet Assay demonstrated a weak potential of AFP-Picolinmethylamid to induce primary DNA damage in the liver of male and female rats after treatment with 125 mg/kg AFP-Picolinmethylamid and higher. Thus, AFP-Picolinmethylamid is considered as a weak genotoxin in the rat liver Comet Assay.
Justification for selection of genetic toxicity endpoint
Only one study available each for Ames test, micronucleus test and liver comet assay
Short description of key information:
Salmonella/microsome test (Ames test): positive with strains TA 98 and TA 100 (+ S9 mix) and negative with strains TA 102, TA 1535 and TA 1537 (+/- S9 mix)
Bone marrow micronucleus test: negative up to 500 mg/kg bw.
Liver comet assay: weak potential to induce primary DNA damage at 125, 250 and 500 mg/kg bw.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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