Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterical mutation test; AMES (OECD TG 471): not mutagenic (Isobionics 2020; STUGC19AA2401-1)
Genetic toxicity in vivo
Description of key information
No data available
Additional information
Mutagenicity in bacteria
In the key study according to OECD TG 471 and GLP, Santalol oil was investigated for its potential to induce gene mutations according to the plate incorporation test (Exp. I) and the pre-incubation test (Exp. II) protocol using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and tester strain E. coli WP2 uvrA (pKM 101) with and without metabolic activation (Isobionics 2020; STUGC19AA2401-1). All test concentrations and negative (aqua dest), vehicle (DMSO) and positive (sodium azide, 4-nitro-o-phenylene-diamine, methylmethanesulfonate, 2-aminoanthracene) controls were tested in triplicates. Test substance concentrations ranged from 0.0001 µl up to 5 μL Santalol oil per plate.
No precipitation of Santalol oil was observed in any tester strain used in Exp. I (without metabolic activation) and II (with and without metabolic activation). Precipitation of the test item was observed in all tester strains used in Exp. I (with metabolic activation).
Toxic effects of the test item were noted in all tester strains used in both experiments. In the plate incorporation test (Exp. I) toxic effects of Santalol oil were observed at concentrations of 0.0316 μL/plate and higher (without metabolic activation) and at concentrations of 0.316 μL/plate and higher (with metabolic activation) depending on the tester strain used. In the pre-incubation test (Exp. II) toxic effects were noted at concentrations of 0.001 μL/plate and higher (without metabolic activation) and at concentrations of 0.0316 μL/plate (with metabolic activation) depending on the tester strain.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Santalol oil at any concentration level, neither in the presence nor absence of metabolic activation in the plate incorporation and pre-incubation test (Exp. I and II). All criteria of validity - including the results observed for the negative and positive controls - were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Santalol oil did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Santalol oil is considered to be non-mutagenic in this bacterial reverse mutation assay under the test conditions chosen.
Justification for classification or non-classification
The present data on genetic toxicity do not fulfill the criteria laid down in regulation (EU) 1272/2008 and therefore, a non-classification is warranted.
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