Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 950-969-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.