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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 264-705-7 | CAS number: 64147-40-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although the study is well documented, meets generally accepted scientific principles, acceptable for assessment.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- IUPAC Name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- Details on test material:
- - Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8). Under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not reported
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 and 30% Aroclor 1254-induced S9 from male Syrian hamster liver and male Sprague Dawley rat liver
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333 and 10000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Tested on TA100 and TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Tested on TA97
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- Tested on TA 98, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Pre-incubation. The detailed protocol of Zeiger et al. (1988) was followed.
NUMBER OF REPLICATIONS: Three - Evaluation criteria:
- Not reported
- Statistics:
- Not reported
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the test conditions, castor oil can be considered to be non-mutagenic in a Salmonella typhimurium mutation assay (Ames test). - Executive summary:
A study was performed to investigate the potential mutagenicity of castor oil through the reverse mutation assay using Salmonella typhimurium strains TA 1535, TA 97, TA 98 and TA 100, along with Aroclor-induced 10 and 30% liver fraction for metabolic activation (S9-mix).
Salmonella strains were exposed to five different concentrations (0, 100, 333, 1,000, 3,333 and 10,000 µg/plate) of castor oil and vehicle control (DMSO), in both absence and the presence of S9-mix. Three parallel plates were used for each dose. Concurrent positive controls, 2-aminoanthracene (for all strains, with metabolic activation), 4-nitro-o-phenylenediamine (on TA 98, without metabolic activation), sodium azide (TA100 and TA1535) and 9-aminoacridine (TA97) were also included in the assays.
In both absence and presence of the S9-mix, castor oil did not cause a significant increase in the number of revertant colonies in comparison to the control. Both positive and vehicle control groups were also valid.
Hence, under the test conditions, castor oil can be considered to be non-mutagenic in a Salmonella mutation assay (Ames test).
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