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Administrative data

Key value for chemical safety assessment

Additional information

In-vitro bacterial reverse mutation assay:

Key study: Read-across approach from the experimental data on the analogue isobornyl acetate.

An in-vitro bacterial reverse mutation assay (Ames test) was performed with the analogue substance isobornyl acetate in accordance with OECD 471. Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were exposed up to 500 µg/plate test item in DMSO with and without metabolic activation. No mutagenic effect occurred with and without metabolic activation in any of the five strains. Based on the read-across approach, dextro alpha fenchyl acetate was determined to be not mutagenic in the Ames test.

In-vitro mammalian cell gene mutation assay:

Key study: Experimental results on the test item:

An in vitro mammalian cell assay was performed in mouse lymphoma L5178Y TK+/- 3.7.2 C cells at the tk locus (OECD 476) to test the potential to cause gene mutation and/or chromosome damage. Based on preliminary results, treatment was performed for 3 hours with and without metabolic activation (±S9 mix) and for 24 hours without metabolic activation (-S9 mix) up to 140 µg/mL in ethanol. No biologically relevant or statistically significant increase in the mutation frequency was observed. No dose response to the treatment was indicated by the linear trend analysis. In conclusion, no mutagenic effect was observed either in the presence or in the absence of metabolic activation system under the conditions of this Mouse Lymphoma Assay.

In-vivo micronucleus assay:

Key study: Read-across approach from the experimental data on the analogue isobornyl acetate

An in-vivo micronucleus test was performed with the analogue isobornyl acetate according to OECD 474. Five mice per sex and per group (70 in total) were exposed to a single dose of test item at 2000 mg/kg bw. Animals were killed 24, 48 and 72 hours after administration of the test compound and bone marrow erythrocytes were observed for micronuclei. The number of polychromatic and normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment and was statistically not different from the control values, indicating no mutagenicity. Based on these results, the read-across approach was applied and dextro alpha fenchyl acetate was determined to be not mutagenic in the micronucleus test.


Justification for selection of genetic toxicity endpoint
No study was selected, since all available studies were negative.

Short description of key information:
In-vitro bacterial reverse mutation assay: Key study: Test method OECD 471, GLP study: Based on the read-across approach, dextro alpha fenchyl acetate was determined to be not mutagenic with and without metabolic activation.
In-vitro mammalian cell gene mutation assay: Key study: Test method OECD 476, GLP study: No mutagenic effects were observed either in the presence or in the absence of metabolic activation system.
In-vivo micronucleus assay: Key study: Test method OECD 474, GLP study: Based on read-across approach, dextro alpha fenchyl acetate was determined to be not mutagenic in mice.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information, the substance is considered to be negative for genetic toxicity, and therefore the substance is not classified in accordance with CLP Regulation (EC) no 1272/2008.