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Diss Factsheets
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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
Description of key information
Skin: OECD TG 439, EpiDerm (TM) in vitro Skin Irritation Test (30 µL single exposure (undiluted)): non-irritant (BASF 2020; 68V0058/20A007)
Eye: OECD TG 492, EpiOcular(TM) in vitro Eye Irritation Test (50 µL single exposure (undiluted)): non-irritant (BASF 2020; 68V0058/20A008)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the key study for skin irritation (in accordance with TG OECD 439), 3 human reconstituted epidermis tissues (EpiDerm™) were treated with 30 µL undiluted Santalene Oil for 1 hour followed by a 42-hour post-incubation period, and a subsequent cell viability (MTT) test (BASF 2020; 68V0058/20A007). In addition to the test substance, control tissues were applied concurrently with 30 µL sterile PBS as negative control or with 30 µL 5% SDS as positive control to 3 tissues each. The optical density of the extracts of the tissues treated with the test substance was compared to negative control values from tissues treated with PBS, expressed as relative tissue viability. Based on the result of a pretest, the test substance is able to reduce MTT directly. Therefore, additional MTT reduction controls (freeze-killed control tissues) were applied concurrently with 30 µL sterile PBS or undiluted test substance (3 tissues each). However, the results of the killed control tissues did not indicate an increased MTT reduction.
Incubation of the reconstituted tissues with Santalene Oil resulted in a mean viability of 97.3% (+/- 4.9% SD) compared to respective control tissue viabilities. Treatment with the positive control resulted in a mean viability of 2.1% (+/- 0.2% SD) compared to respective control tissue viabilities.
Based on the results observed and by applying the evaluation criteria described, it was concluded that Santalene Oil does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation test under the test conditions chosen.
Eye irritation
In the key study for eye irritation (in accordance with TG OECD 492), 2 EpiOcular™ tissues were treated with 50 µL undiluted Santalene Oil, covering the whole tissue surface for 30 minutes followed by a 2-hour post-incubation period, and a subsequent cell viability (MTT) test (BASF 2020; 68V0058/20A008). In addition to the test substance, control tissues were applied concurrently with 50 µL sterile deionized water as negative control or with 50 µL methyl acetate as positive control to 2 tissues each. The optical density of the extracts of the tissues treated with the test substance was compared to negative control values, expressed as relative tissue viability. Based on the result of a pretest, the test substance is able to reduce MTT directly. Thus, two freeze-killed control tissues were treated additionally with each the test item and the negative control in the same way as the viable tissues. The results of the freeze-killed control tissues indicate an increased MTT reduction (relative mean tissue viability 0.1 % of the negative controls). Thus, the final mean viability values for test substance treated tissues were corrected accordingly.
Incubation of the reconstituted tissues with the test substance resulted in a mean viability of 100.6% (+/- 4.3% inter-tissue variability) compared to respective control tissue viabilities. Treatment with the positive control resulted in a mean viability of 20.7% (+/- 7.0% inter-tissue variability) compared to respective control tissue viabilities.
Based on the results observed in the EpiOcular™ test alone and by applying the evaluation criteria, it was concluded that Santalene Oil does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen. Using the currently available in vitro methods, a single in vitro assay is not sufficient to cover the full range of an eye-irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and the Permeability Test (BCOP Test) and EpiOcular™ Eye Irritation Test (EIT). In case of the data obtained for Santalene Oil, the results derived with EpiOcular™ test alone were sufficient for a final assessment. Therefore, further testing in a BCOP test was waived.
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 skin or eye irritant 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.
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