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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

AMES II Assay (similar to OECD TG 471): non-mutagenic with and without metabolic activation (BASF 2020; 44M0058/20M033)

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key study for mutagenicity in bacteria, i.e. a Salmonella typhimurium reverse mutation assay (Liquid fluctuation test - microtiter version; Ames II Assay) similar to OECD TG 471, Santalene Oil was tested at 4, 20, 100, 500, 2500 and 5000 µg/mL in DMSO using several strains of Salmonella typhimurium (TA 98 or TA 7001 - 7006 [=TA Mix]) both with and without the addition of a metabolizing system (S9 mix) from livers of induced male Wistar rats (BASF 2020; 44M0058/20M033). This method shows a good accuracy concerning the prediction of the results in the regular Ames test. A bacteria suspension (240 µL) was incubated with 10 µL test substance, vehicle or positive controls in the presence or without S9 mix (40 µL) in 24-well plates at 37°C for about 90 minutes. After this incubation period, bacteria were transferred to indicator medium (containing bromocresol purple) and respective 50 µL aliquots were transferred to and incubated in 348-well Revertant Colony Selection plates (RCSP) at 37°C for 48 hours. The wells of the RCSP were scored and the number of positive wells (yellow = high number of his' revertants) were counted. Each experiment included negative controls (vehicle control) and positive controls (2-aminoanthracene (with S9 mix), 2-nitrofluorene + 4-nitroquinoline-N-oxide without S9 mix)).

No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) but precipitation starting at 500 µg/ml was observed. An increase in the number of positive wells (his+ revertants) was not observed either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance Santalene Oil is not a mutagenic substance in the Ames II Assay (Salmonella typhimurium reverse mutation assay) in the absence and the presence of metabolic activation.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. According to these data the criteria for a classification as mutagenic under Regulation (EC) No. 1272/2008 are not met.