Registration Dossier
Registration Dossier
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: 253-057-0 | CAS number: 36483-57-5
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- EC Number:
- 253-057-0
- EC Name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- Cas Number:
- 36483-57-5
- Molecular formula:
- C5H9Br3O
- IUPAC Name:
- 3-bromo-2,2-bis(bromomethyl)propan-1-ol
- Details on test material:
- identification: FR-513
Description: Off-white flakes
Batch #: 201059107
Storage conditions: Room temperature, in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley CD (Ctr;CD (SD) IGS BR) strain rats were obtained from Charles River UK Ltd, Margate, Kent, UK.
Weight: male 200 gr-243 gr (start of experiment); Age: 6-9 weeks old
Acclimatisation period: at least 5 days
Housing: The animals were housed in groups of up to five in solid floor polypropylene cages with woodflake bedding. Free access to drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analysed for contaminants.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30-70% respectively.
Air change was at least 15 changes per hour and the lightning was controlled by a time switch to give 12 hr continuous light (06:00 to 18:00) and 12 hr darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Archis oil
Description: Pale straw coloured slightly viscous liquid
Storage: Room temperature - Details on exposure:
- All animals were dosed once only at room temperature at the appropriate dose level by gavage usin a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its body weight at the time of dosing.
- Duration of treatment / exposure:
- Treatment: 16 hr (experiment 1); 2 hr (experiment 2)
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
nominal in diet
range finder test
- Remarks:
- Doses / Concentrations:
670 mg/kg; 2000 mg/kg
Basis:
nominal in diet
main test 1
- Remarks:
- Doses / Concentrations:
670 mg/kg; 2000 mg/kg
Basis:
nominal in diet
main test 2
- No. of animals per sex per dose:
- range finder: 2 (1 male; 1 female) (2 males 0 females)
main test 1: 4 per dose (males); main test 2: 4 per dose (males) - Control animals:
- yes
- Positive control(s):
- 2- Acetamididofluorene (2AAF)
Off-white solid
Storage: room temperature
Dose: 50 mg/kg
Sym-Dimethylhydrazine dihydrochloride (NDHC)
White crystalline solid
storage conditions: room temperature, over silica gel
Dose: 40 mg/kg
Examinations
- Tissues and cell types examined:
- Liver Hepatocytes
- Details of tissue and slide preparation:
- See attached document on tissue and slide preparation
- Evaluation criteria:
- The coded slides were scored using an automated image analysis system linked to a computer programe (Grain) which followed the UKEMS guidelines for statistical analysis. For further details see attached document on evaluation criteria
- Statistics:
- no
Results and discussion
Test resultsopen allclose all
- Sex:
- male/female
- Genotoxicity:
- not determined
- Remarks:
- range finder test
- Toxicity:
- yes
- Remarks:
- 2000 mg/kg: ataxia, lethargy, red colored urine (no deaths)
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- no increase in the incidence of cells in repair at any dose level
- Toxicity:
- yes
- Remarks:
- main test 1+2: lethargy and ataxia
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- there were no marked increases in the incidence of unscheduled DNA synthesis in animals dosed with the test material at either time point. Both positive and negative controls produced marked increases in the incidence of cells in repair and the vehicle control groups gave acceptable values for net nuclear grain counts.
Further see attached document on results
Any other information on results incl. tables
See attached document on tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative The test material did not induce any marked or toxcologiacally significant increases in the incidence of cells undergoing DNA synthesis
The test material did not induce any marked or toxicologically significant increases in the incidence of cells undergoing unscheduled DNA synthesis in isolated rat hepatocytes following in vivo exposure for 2 or 16 hr. Therefore the test material was considered to be non-genotoxic under the conditions of the study. - Executive summary:
A study was performed to assess the potential of the test material to induce DNA repair in isolated rat hepatocytes following in vivo administration. The method used has been designed to comply with the relevant guidelines such as OECD 486.
The study resulted in no marked increases in the incidence of unscheduled DNA synthesis in animals dosed with the test material at either time point. Both positive and negative controls produced marked increases in the incidence of cells in repair and the vehicle control groups gave acceptable values for net nuclear grain counts. Therefore the test material was considered to be non-genotoxic under the conditions of the study.
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.
