Registration Dossier
Registration Dossier
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EC number: 402-770-7 | CAS number: 92585-24-5 PAMPLEFLEUR
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test
An Ames test was performed according to OECD TG 471, using S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 as well as E.coli strains WP2, up to 5000 ug/pl. No mutagenicity was observed.
Mouse Micronucleus study:
An in vivo mouse micronucleus test was performed according to OECD TG 474 up to 871 mg/kg bw. Mice treated with Pamplefleur showed no significant increase in the frequency of micronucleated polychromatic erythrocytes. There was no siqnificant change in the ratio of polychromatic to normochromatic erythrocytes after treatment of the animals with Pamplefleur. The substance is not considered genotoxic in this test.
Justification for selection of genetic toxicity endpoint
One AMES study was conducted with Pamplefleur according to OECD TG 471 guidelines, including GLP and with a reliability 1 and no mutagenicty was observed under the conditions of this test. There was also an OECD TG 474 in vivo mouse micronucleus study conducted under GLP and with a reliability 1, which showed no genotoxicity.
Short description of key information:
AMES study:
It is concluded that Pamplefleur shows no evidence of mutagenic activity when tested in this bacterial system.
Mouse Micronucleus:
From the results obtained it is concluded that Pamplefleur shows no evidence of mutagenic potential or bone marrow cell toxicity when administered orally in this in vivo test procedure.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test material is not classified for genotoxicity based on the Ames study and an in vivo mouse micronucleus study.
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