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EC number: 944-461-4 | 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
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No historical negative or positive control data were reported, dose volume was 20 mL/kg bw instead of max. 10 mL/kg bw, 2000 immature erythrocytes/animal were scored instead of 4000.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted Sep 2014
- Deviations:
- yes
- Remarks:
- No historical negative or positive control data were reported, dose volume 20 mL/kg bw, 2000 immature erythrocytes/ animal were scored
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals (State Environmental Protection Administration of China) 2004.5
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T 154-2004)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- EC Number:
- 306-832-3
- EC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Cas Number:
- 97416-84-7
- Molecular formula:
- C23H24Br8O2
- IUPAC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Kunming (SPF grade)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd., Beijing, China
- Weight at study initiation: 25 - 28 g (females, main study), 26 - 28 g (males, main study); 18.1 - 20.4 (females, preliminary study), 18.7 - 20.1 (males, preliminary study)
- Fasting period before study: from 12 h before dosing until 3 h after (preliminary study only)
- Housing: the animals were housed in clear plastic cages with stainless steel tops
- Diet: feed (SCXK (JIN) 2012-0001, Tianjin Huarong Laboratory Animal Science and Technology Co., Ltd., Tianijin, China), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 50 ± 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: vegetable oil
- Justification for choice of solvent/vehicle: the test substance formed a dosable and apparently miscible suspension in vegetable oil
- Concentration of test material in vehicle: approximately 100 mg/mL; administered as 2 mL/100 g bw - Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- daily (2 doses in total)
- Post exposure period:
- 24 h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: intraperitoneal injection
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: No mortality or signs of toxicity were noted in mice administered a single dose of 5000 mg/kg bw in the range-finding study. The recommended limit dose according the OECD guideline 474 is 2000 mg/kg bw for administration periods of less than 14 days. Therefore the limit dose of 2000 mg/kg bw/day was selected.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): the bone marrow cells were harvested 24 h after the last test substance administration.
DETAILS OF SLIDE PREPARATION: Slides were fixed with methanol and stained with Giemsa solution.
METHOD OF ANALYSIS: 2000 polychromatic erythrocytes (PCE) were scored per animal to determine the frequency of micronucleated polychromatic erythrocytes (MNPCE). The ratio of polychromatic to monochromatic erythrocytes (PCE/NCE) was determined. - Statistics:
- The statistical significance between groups was analysed using ANOVA. All results were expressed as mean ± standard deviation; values were considered significant at p < 0.05.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5000 mg/kg bw
- Clinical signs of toxicity in test animals: none
- Rationale for exposure: the range-finding study was performed to establish the highest dose level at which no or low systemic toxicity was observed.
- Other: 5 mice/sex were administered 5000 mg/kg bw by gavage as a single dose. There was no mortality during the 14-day observation period. No adverse clinical signs were observed and the body weight gain was within the expected range for this species and strain. The histopathological examination did not show any abnormal results.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): the induction of micronuclei was not significantly increased in the treatment group, compared with the control group (see Table 1 - 3 under 'Any other information on results incl. tables').
- Ratio of PCE/NCE (for Micronucleus assay): For females, the ratio of PCE/NCE was 1.06, 1.06 and 1.05 for the vehicle, treatment and positive control group, respectively. For males, the ratio of PCE/NCE was 1.05, 1.03 and 1.02 for the vehicle, treatment and positive control group, respectively.
- Appropriateness of dose levels and route: the route and dose level was suitable under the conditions of the study.
- Statistical evaluation: the difference between the vehicle control and test substance group was not significant.
OTHER:
No effects on body weight were observed in any of the control or treatment groups.
Any other information on results incl. tables
Table 1: Results of the in vivo micronucleus assay in male animals
|
|
|
Total micronuclei per 2000 PCEs at sampling time |
Exp group |
Number of animals/sex |
Dose [mg/kg bw] |
24 h |
Vehicle control (vegetable oil) |
5 |
0 |
7 |
Test substance
|
5 |
2000 |
11 |
Positive control (cyclophosphamide) |
5 |
40 |
192* |
*statistically significant (p<0.05);
Table 2: Results of the in vivo micronucleus assay in female animals.
|
|
|
Total micronuclei per 2000 PCEs at sampling time |
Exp group |
Number of animals/sex |
Dose [mg/kg bw] |
24 h |
Vehicle control (vegetable oil) |
5 |
0 |
10 |
Test substance
|
5 |
2000 |
8 |
Positive control (cyclophosphamide) |
5 |
40 |
205* |
*statistically significant (p<0.05);
Table 3: Results of the in vivo micronucleus assay
Treatment group |
Dose [mg/kg bw] |
Sampling time [h] |
Mean frequency of PCE with MN
|
PCE/NCE ratio |
Females |
||||
Vehicle control (vegetable oil) |
0 |
24 |
0.01 |
1.06 ± 0.04 |
Test substance |
2000 |
24 |
0.01 |
1.06 ± 0.04 |
Positive control (cyclophosphamide) |
40 |
24 |
2.05 |
1.05 ± 0.02 |
Males |
||||
Vehicle control (vegetable oil) |
0 |
24 |
0.07 |
1.05 ± 0.03 |
Test substance |
2000 |
24 |
0.08 |
1.03 ± 0.03 |
Positive control (cyclophosphamide) |
40 |
24 |
1.92 |
1.02 ± 0.04 |
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.
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