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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

OECD 471: In vitro bacterial reverse mutation assay: Negative

OECD 473: In vitro chromosome aberration assay using Chinese Hamster lung cells (CHL/IU): Negative

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an OECD 471 study, the potential of HCFO-1233yd(Z) to induce genetic mutations in 5 bacterial strains was evaluated in the absence and presence of metabolic activation (±S9). In both the non-activated and activated assays, the average number of revertants in the test substance group was less than twice that in the corresponding negative control group in all tester strains and the number of revertants did not increase in a dose-related manner. No inhibition of cell growth or precipitation of the test substance was observed in any tested strain. Based on the results observed, the test material was not considered to be mutagenic under the conditions of this bacterial reverse mutation assay.

In a key OECD Guideline 473 study (Safety Research Institute for Chemical Compounds Co., Ltd, 2016), the clastogenic potential of the test material (HCFO-1233yd(Z)) was investigated in vitro using Chinese Hamster lung cells (CHL/IU). The test material was evaluated in three test series: short-term treatment without S9 (-S9 treatment); short-term treatment with S9 (+S9); and continuous 24-hour treatment (24-hr treatment). Based on the results of effects on cell growth, 350, 700, and 1400 µg/mL were selected as the doses.

Incidence of structural and numerical aberrations of chromosomes in the negative control groups of all test series were within the control range based on the historical control data. The incidence of structural aberrations of chromosomes in the positive control group of all test series were within the control range based on the historical control data, and a statistically significant increase was noted compared with the negative control group.

Treatment with the test material resulted in no increase in the incidence of structural or numerical aberrations of chromosomes. Based on the results observed, the test material is was not considered to be clastogenic to cultured mammalian cells under the conditions of this in vitro chromosome aberration test.

In a key OECD guideline 476 study, the test item did not induce any toxicologically significant increases in the mutant frequency at any of the concentration levels in the main test using a dose range that included the 10 mM limit dose level, in either the absence or presence of metabolic activation.Therefore, the test item was shown to be non-mutagenic to V79 cells at the HPRT locus under the conditions of the test.

Justification for classification or non-classification

The available in vitro data indicate that classification for genotoxicity is not warranted.

HCFO-1233yd(Z) is not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).