Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the consistent lack of genotoxicity in the tests systems, POPDA is considered to be non genotoxic in vivo.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Based on the consistent lack of genotoxicity in the tests systems, POPDA is considered to be non genotoxic in vitro.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

In a bacterial reverse gene mutation assay with multiple strains of Salmonella typhimurium (similar to OECD 471), POPDA was negative both with and without metabolic activation.

In a mammalian cell gene mutation assay with L5178Y mouse lymphoma cells, exposure to POPDA (similar to OECD 476) in the presence and absence of metabolic activation did not induce mutations at the thymidine kinase locus up to a dose level of 6000 nl/ml.

In an in vitro BALB/3T3 cell transformation assay, POPDA did not induce the appearance of a significant number of transformed foci over the concentration range of 450 nl/ml to 75 nl/ml. Therefore, POPDA is considered to be inactive in the BALB/3T3 in vitro transformation assay.

In an in vivo micronucleus test on mouse bone marrow erythrocytes, performed according to OECD 474, the animals were exposed orally (via gavage) with 125, 250 and 500 mg/kg. This did not induce a statistically positive increase in micronuclei in the hemopoietic cells of the mouse bone marrow at the time intervals evaluated under the experimental condition of this assay. No toxicity was observed. Vehicle and positive controls were valid.


Short description of key information:
Negative results were reported in high quality in vitro and in vivo genetic toxicity studies comparable to OECD guidelines 471, 474 and 476, and in an in vitro transformation of BALB/3T3 cells assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the consistent lack of genotoxicity in the tests systems, POPDA is considered to be non genotoxic in vitro and in vivo. Therefore, the substance does not warrant classification.