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EC number: 289-612-9 | CAS number: 89957-91-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus bergamia risso, Rutaceae.
- 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
Additional information
Gene mutation in bacteria
The key study was an Ames test in bacteria according to a method similar to OECD guideline 471 (Ames test). The plate incorporation assay was performed with concentrations of 0.125, 0.25 and 0.5 µl/plate, with and without metabolic activation. Negative and positive controls were included as well. The frequency of revertant colonies was recorded.
The positive and negative control were valid: all positive control chemicals induced an increase in frequency of revertant colonies for the relevant strains. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
Based on the results of this Ames test, the test item Citrus bergamia Risso was considered to be non-mutagenic under the conditions of the test.
In vitro mammalian chromosome aberration test
Two in vitro chromosomal aberration tests performed according to OECD guideline 473 for the test substances Lime oil and Lemon oil were available. These results are evaluated in a weight of evidence approach and read across to Bergamot oil, see the read across justification document.
In the in vitro chromosomal aberration test with Lime oil Chinese hamster fibroblast cells (CHL) were continuously exposed to three different doses (with 0.04 mg/ml as maximum) for 24 and 48 hours without metabolic activation. Lime oil did not significantly induce chromosomal aberrations in CHL cells in vitro at three different concentrations in the absence of metabolic activation and was therefore considered not clastogenic in this test.
In the in vitro chromosomal aberration test with Lemon oil Chinese hamster fibroblast cells (CHL) were continuously exposed to three different doses (with 0.125 mg/ml as maximum) for 24 and 48 hours without metabolic activation. Lemon oil did not significantly induce chromosomal aberrations in CHL cells in vitro at three different concentrations in the absence of metabolic activation and was therefore considered not clastogenic in this test.
Based on the data for Lemon and Lime oil no cytogenicity is expected for Bergamot oil.
In vitro mammalian cell gene mutation test
The key study was an in vitro mammalian cell gene mutation test performed according to OECD guideline 476 for the test substances Lemon Oil Cold Pressed 1-Fold-Lemon, ext. (Citrus limonum, Rutaceae), in short Lemon oil. The result of this test is read across to Bergamot oil, see the read across justification document.
In the in vitro mammalian cell gene mutation test mouse L5178Y lymphoma cells were exposed to various concentrations of Lemon Oil Cold Pressed 1-Fold-Lemon, ext. Two experiments were performed: 1) experiment testing Lemon oil at concentrations of 70 and 450 µg/ml with and without 8% S9 mix during incubation for 3 hours; and 2) experiment testing Lemon oil at concentrations of 55 and 500 µg/ml with and without 12% S9 mix during incubation for 3 hours (with S9) and 24 hours (without S9).
In the absence and in the presence of S9-mix the test substance did not induce a significant increase in the mutation frequency in both experiments. It is concluded that Lemon Oil does not induce gene mutations under the experimental conditions described in the report.
Based on these data for Lemon oil no mutagenicity is expected for Bergamot oil.
Justification for selection of genetic toxicity endpoint
No selection is made as a Weight of Evidence approach was followed which is described below.
Short description of key information:
- Gene mutation in bacteria: (Bacterial Reverse Mutation Assay/Ames) (according to OECD 471): not mutagenic.
- In vitro Mammalian chromosome aberration test (equivalent or similar to OECD 473): not clastogenic without metabolic activation.
- In vitro Mammalian cell gene mutation test (according to OECD 476): negative.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Considering the outcome of the available genotoxicity studies, it can be concluded that Bergamot oil is not genotoxic and does not need to be classified for genotoxicity in accordance with the criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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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