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Diss Factsheets
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EC number: 832-827-5 | 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
Carcinogenicity
Administrative data
Description of key information
This review was undertaken to assess the carcinogenic potential of SynNova® Base Oil (CAS: 2241366-04-9). The focus of the review was on tests and studies that included genotoxicity endpoints and a 90-day oral (gavage) toxicity study in rats. The assessment looked for the principal factors in carcinogenesis that have been identified by many authors including genotoxicity, hormonal modulation, immunosuppression, chronic toxicity and changes in cell growth or survival (hyperplasia, hypertrophy, or apoptosis). All reports reviewed were GLP-compliant and were considered to be valid.
Genotoxicity was comprehensively characterised in three tests in vitro and in one test in vivo. The overall conclusion from these studies is that SynNova® Base Oil does not have any genotoxicity either in vitro or in vivo While there was no toxicokinetic evidence in the in vivo test that the exposure of the bone marrow was achieved, this is considered to be offset by the absence of effect in vitro, where the test systems were directly exposed to the test item.
Hormonal modulation was examined in three studies in rats, including a definitive study conducted according to OECD test guideline 443. There was no evidence of any effect on hormonal function, seen as a lack of treatment-related change in thyroid hormone concentrations, in thyroid weight and morphology and in similar absence of change in other endocrine tissues, including the adrenals, pituitary and gonads.
There was no indication of immunological change in any of these studies shown by the absence of change in the thymus or in other immune system tissues. In particular, there were no differences in white cell counts (total or differential) or in protein fractions (total protein, albumin, globulins or AG ratio) to indicate any immunological effect.
There was no toxicity in any of these studies in rats that might be seen as pro-carcinogenic. In particular, there was no evidence of hypertrophic or focal change, particularly in the liver, that might indicate effects on cell turnover – either increased or decreased – that might be associated with carcinogenic potential.
The potential utility of further testing for carcinogenicity was considered and given the universally negative results in the studies reviewed and the doubtful utility of such studies in human risk assessment, it was concluded that such studies would not add materially to the information already available on SynNova® Base Oil.
The conclusion of this review of a number of GLP-compliant studies of genotoxicity, both in vitro and in vivo, and of three comprehensive studies in rats was that SynNova® Base Oil does not exhibit any carcinogenic potential and that further testing would not add usefully to the information already available.
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
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.