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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 294-589-3 | CAS number: 91744-27-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- other: NTP summary information
- Title:
- Unnamed
- Year:
- 1 987
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Remarks:
- NTP study
- Type of assay:
- other: Chromosome aberration assay in mamalian cells
Test material
- Reference substance name:
- Castor oil
- EC Number:
- 232-293-8
- EC Name:
- Castor oil
- Cas Number:
- 8001-79-4
- IUPAC Name:
- Castor Oil
Constituent 1
- Specific details on test material used for the study:
- Name as cited in study report: Castor oil
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- To assess induction of CA, cells were harvested in their first mitotic division after the initiation of chemical exposure.
MEDIA USED
McCoy's 5A medium supplemented with fetal calf serum, L-glutamine, and antibiotics; Colcemid
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced Sprague Dawley rat liver S9-mix
- Test concentrations with justification for top dose:
- 1600, 3000 and 5000 µg/mL
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µg/mL
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Without S9-mix: cells were incubated with study compound or solvent for 10 h at 37°C. Cells were then washed and fresh medium containing colcemid was added for an additional 3 h followed by harvest.
- With S9-mix: cells were incubated with study compound or solvent for 2 h at 37°C. Cells were then washed, medium without test compound was added, and incubation was continued for 10 h. Colcemid was added for the last 3 h of incubation before harvest.
- Expression time (cells in growth medium): 12 (without metabolic activation) or 13 hours (with metabolic activation).
SPINDLE INHIBITOR: colcemid
STAIN (for cytogenetic assays): The cells were harvested by mitotic shake-off, fixed, and stained with 6% Giemsa
NUMBER OF CELLS EVALUATED: 200 or 50 for the high dose positive control - Evaluation criteria:
- For a single trial, a statistically significant (P<0.05) difference for one dose point and a significant trend (P<0.015) was considered weak evidence for a positive response; significant differences for two or more doses indicated the trial was positive. A strong trend (P < 0.003) with a single significant dose level was designated weak positive *, to indicate a high level of induced aberrations. A strongly positive trend (P < 0.003), in the absence of a statistically-significant increase at any one dose point, led to an equivocal call. Ultimately, the trial calls were based on a consideration of the statistical analyses as well as the biological information available to the reviewers. Trials that gave a weak positive or positive result were repeated. The overall result for the CA assay was based on an evaluation of the responses in all trials within an activation condition.
- Statistics:
- To arrive at a statistical call for a trial, analyses were conducted to assess the presence of a dose-response (trend test) and the significance of the individual dose points compared to the vehicle control
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
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.