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EC number: 247-426-5 | CAS number: 26040-51-7
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- The effect of RC 9927 (bis(2-ethylhexyl)tetrabromophthalate) on chromosome structure in bone marrow cells was investigated following acute intraperitoneal and sub-acute dermal administration to mice. Chromosome damage was measured indirectly by counting micronuclei.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Bis(2-ethylhexyl) tetrabromophthalate
- EC Number:
- 247-426-5
- EC Name:
- Bis(2-ethylhexyl) tetrabromophthalate
- Cas Number:
- 26040-51-7
- Molecular formula:
- C24H34Br4O4
- IUPAC Name:
- 1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate
- Test material form:
- liquid
- Details on test material:
- RC 9927 (batch 6159-199-3), also identified as FR-45B, a slightly turbid, viscous pale yellow liquid received from Pennwalt Corporation on 1st September 1986.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- dermal
- Duration of treatment / exposure:
- Intraperitoneal route: animals were killed 48 or 72 hours after treatment.
Dermal route: animals were treated 5 days and killed 18 or 48 hours after the final treatment. - Frequency of treatment:
- Intraperitoneal: single treatment.
Dermal: 5 separate treatments (24 hour intervals). - Post exposure period:
- None
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000, 2000 mg/kg bw
Basis:
nominal conc.
main micronucleus test - intraperitoneal route
- Remarks:
- Doses / Concentrations:
0, 2000 mg/kg bw
Basis:
nominal conc.
main micronucleus test - dermal application
- No. of animals per sex per dose:
- Main Micronucleus Test - intraperitoneal route
Group Treatment Dosage Number Animal
(mg/kg) of mice numbers
1 Corn oil - 15M 17 - 31
15 F 62 - 76
2 RC 9927 80 5M 32 - 36
5F 7 - 81
3 RC 9927 400 5M 37 - 41
5F 82 - 86
4 RC 9927 2 000 15M 42 - 56
15F 87 - 101
5 Chlorambucil 30 5M 57 - 61
5F 102 - 106
Main Micronucleus Test - dermal application
Group Treatment Dosage Number Animal
(mg/kg) of mice numbers
6 Corn oil - 10M 107 - 116
10F 127 136
7 RC 9927 2000 10M 117 - 126
10F 137 - 146
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- erythrocytes of bone marrow cells
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Frequencies of micronucleated polychromatic erythrocytes in animals exposed to RC 9927 (bis(2-ethylhexyl)tetrabromophthalate) for 24, 48 or 72 hours via the intraperitoneal route were similar to those in concurrent controls. This lack of treatment-related effect was confirmed by statistical analysis.
Frequencies of micronucleated polychromatic erythrocytes in animals treated dermally for 5 days with RC 9927 (bis(2-ethylhexyl)- tetrabromophthalate) and sacrificed 18 or 48 hours after the final treatment were also similar to those in concurrent controls. Again, statistical analysis confirmed that there was no significant increase in the frequencies of micronucleated polychromatic cells in RC 9927 (bis(2-ethylhexyl)tetrabromophthalate) treated groups compared to concurrent vehicle control groups at either termination time.
Statistically significant increases over controls were seen in positive control group animals given chlorambucil at 30 mg/kg (p < 0.01).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The effect of RC 9927 (bis(2-ethylhexyl)tetrabromophthalate) on chromosome structure in bone marrow cells was investigated following acute intraperitoneal and sub-acute dermal administration to mice. Chromosome damage was measured indirectly by counting micronuclei.
Frequencies of micronucleated polychromatic erythrocytes in animals exposed to RC 9927 (bis(2-ethylhexyl)tetrabromophthalate) for 24, 48 or 72 hours via the intraperitoneal route were similar to those in concurrent controls. This lack of treatment-related effect was confirmed by statistical analysis.
Frequencies of micronucleated polychromatic erythrocytes in animals treated dermally for 5 days with RC 9927 (bis(2-ethylhexyl)- tetrabromophthalate) and sacrificed 18 or 48 hours after the final treatment were also similar to those in concurrent controls. Again, statistical analysis confirmed that there was no significant increase in the frequencies of micronucleated polychromatic cells in RC 9927 treated groups compared to concurrent vehicle control groups at either termination time.
Statistically significant increases over controls were seen in positive control group animals given chlorambucil at 30 mg/kg (p < 0.01).
Under the conditions of test, there was no evidence of induced chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes of treated mice, after either acute intraperitoneal or sub-acute dermal administration of RC 9927 (bis(2-ethylhexyl)tetrabromophthalate).
Therefore, the test is negative.
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