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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 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:
- key study
- Study period:
- 21 Dec 2009 - 01 Feb 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Type of assay:
- bacterial reverse mutation 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
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon (E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with 80 mg/kg bw/day phenobarbitone and 100 mg/kg bw/day beta-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1 and 2: 50, 150, 500, 1500 and 5000 μg/plate, with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test substance was soluble in DMSO at 50 mg/mL
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- See 'Details on test system and conditions' for concentrations and strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, experiment 1) and preincubation (experiment 2)
DURATION
- Preincubation period: 20 min (experiment 2)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replication each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in growth of bacterial background lawn
OTHER:
- positive control substances used: N-ethyl-N'-nitro-N-nitrosoguanidine (2 μg/plate in DMSO, -S9, WP 2urvA-; 3 μg/plate, -S9, TA 100; 5 μg/plate, -S9, TA 1535); 9-aminoacridine (80 μg/plate in DMSO, -S9, TA 1537); 4-nitroquinoline-1-oxide (0.2 μg/plate in DMSO, -S9, TA 98); 2-aminoanthracene (1 μg/plate in DMSO, +S9, TA 100; 2 μg/plate, +S9 TA 1535 and TA 1537; 10 μg/plate, +S9, WP 2urvA-); benzo-a-pyrene (5 μg/plate in DMSO, +S9, TA 98) - Evaluation criteria:
- There are several criteria for determining a positive result, such as the dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgement about the test material activity. Results of this type will be reported as equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation was observed from 1500 μg/plate in experiment 1 and from 500 μg/plate in experiment 2, with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation was observed from 1500 μg/plate in experiment 1 and from 500 μg/plate in experiment 2, with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitate was observed at concentrations at and above 1500 μg/plate in experiment 1 and concentrations at and above 500 μg/plate in experiment 2, with and without metabolic activation, respectively. This did not affect the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES: A toxicity screening study was performed to determine the toxicity of the test substance. 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate test substance was tested on TA 100 and E. coli WP2 uvrA using the plate incorporation method. Precipitation of the test material was observed at 5000 μg/plate. A range-finding study (plate incorporation method) was performed on all strains using dose levels of 50 - 5000 μg/plate. As the results for all the tested dose levels were valid, the results were used as part of the main study (experiment 1).
COMPARISON WITH HISTORICAL CONTROL DATA: yes, the results of the vehicle and positive controls fell within the range of the historical control data (see Table 3 under 'Any other information on results incl. tables')
ADDITIONAL INFORMATION ON CYTOTOXICITY: No cytotoxicity was observed at any dose level.
Any other information on results incl. tables
Table 1. Test results of experiment 1 (plate incorporation method)
With or without S9-mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
– |
DMSO |
134 ± 5.7 |
27 ± 2.3 |
28 ± 0.6 |
26 ± 2.0 |
11 ± 5.0 |
– |
50 |
136 ± 4.4 |
25 ± 0.0 |
26 ± 2.5 |
27 ± 0.6 |
14 ± 1.5 |
– |
150 |
131 ± 6.4 |
29 ± 3.8 |
25 ± 6.7 |
24 ± 4.5 |
11 ± 3.8 |
– |
500 |
115 ± 21.7 |
28 ± 1.5 |
27 ± 1.2 |
25 ± 1.0 |
17 ± 1.0 |
– |
1500* |
106 ± 18.0 |
25 ± 4.2 |
22 ± 4.7 |
22 ± 3.6 |
10 ± 2.6 |
– |
5000* |
116 ± 5.1 |
32 ± 2.1 |
16 ± 1.7 |
19 ± 1.2 |
10 ± 2.1 |
Positive controls, -S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
429 ± 43.7 |
514 ± 43.1 |
726 ± 77.5 |
133 ± 11.0 |
884 ± 92.2 |
|
+ |
DMSO |
102 ± 11.6 |
12 ± 2.5 |
25 ± 3.5 |
28 ± 2.3 |
12 ± 3.2 |
+ |
50 |
109 ± 10.4 |
12 ± 1.5 |
27 ± 0.6 |
28 ± 3.5 |
15 ± 1.0 |
+ |
150 |
106 ± 3.2 |
12 ± 1.0 |
29 ± 0.6 |
28 ± 1.2 |
11 ± 4.0 |
+ |
500 |
97 ± 1.5 |
14 ± 1.7 |
26 ± 5.0 |
25 ± 2.1 |
13 ± 2.6 |
+ |
1500* |
101 ± 8.1 |
14 ± 1.2 |
24 ± 3.5 |
26 ± 2.6 |
11 ± 2.0 |
+ |
5000* |
93 ± 3.0 |
13 ± 2.6 |
26 ± 2.5 |
27 ± 1.5 |
9 ± 2.6 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BaP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1547 ± 34.6 |
223 ± 24.5 |
367 ± 41.1 |
218 ± 74.1 |
299 ± 29.5 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-nitroquinoline N-oxide
9AA:9-aminocridine
2AA: 2-amino-anthracene
BaP: benzo-a-pyrene
*: precipitation
Table 2. Test results of experiment 2 (plate incorporation method)
With or without S9-mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
– |
DMSO |
102 ± 12.7 |
24 ± 2.5 |
22 ± 6.1 |
18 ± 4.4 |
16 ± 2.5 |
– |
50 |
85 ± 12.4 |
24 ± 5.0 |
21 ± 2.6 |
15 ± 2.3 |
13 ± 1.2 |
– |
150 |
94 ± 7.1 |
24 ± 2.9 |
18 ± 2.5 |
17 ± 5.1 |
13 ± 1.7 |
– |
500* |
90 ± 10.0 |
23 ± 4.0 |
21 ± 0.6 |
20 ± 2.1 |
15 ± 6.1 |
– |
1500* |
94 ± 5.1 |
26 ± 3.5 |
22 ± 1.5 |
20 ± 2.6 |
14 ± 1.5 |
– |
5000* |
96 ± 4.5 |
24 ± 2.3 |
23 ± 3.5 |
20 ± 2.0 |
14 ± 2.0 |
Positive controls, -S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
613 ± 32.2 |
578 ± 58.0 |
861 ± 68.6 |
144 ± 9.5 |
354 ± 120.8 |
|
+ |
DMSO |
99 ± 8.5 |
16 ± 2.1 |
28 ± 5.1 |
27 ± 6.7 |
14 ± 3.2 |
+ |
50 |
90 ± 4.2 |
15 ± 1.0 |
29 ± 1.5 |
25 ± 4.0 |
10 ± 1.5 |
+ |
150 |
94 ± 6.7 |
14 ± 1.5 |
25 ± 3.6 |
25 ± 8.2 |
14 ± 1.5 |
+ |
500* |
98 ± 12.7 |
15 ± 1.2 |
24 ± 3.1 |
28 ± 1.7 |
14 ± 2.0 |
+ |
1500* |
98 ± 2.1 |
16 ± 3.0 |
25 ± 3.6 |
26 ± 4.4 |
16 ± 2.5 |
+ |
5000* |
97 ± 4.7 |
12 ± 1.5 |
26 ± 1.5 |
25 ± 2.3 |
12 ± 1.5 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BaP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
586 ± 96.2 |
235 ± 12.0 |
259 ± 36.7 |
387 ± 51.7 |
165 ± 8.4 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-nitroquinoline N-oxide
9AA:9-aminocridine
2AA: 2-amino-anthracene
BaP: benzo-a-pyrene
*: precipitation
Table 3. Historical controls
Strain |
Control |
without S9-mix |
with S9-mix |
Year |
|
|
Mean ± SD |
Mean ± SD |
|
TA100 |
Solvent/untreated |
94 ± 16.0 |
87 ± 14.8 |
2007 |
TA100 |
Positive |
558 ± 313.5 |
1231 ± 651.1 |
2007 |
TA1535 |
Solvent/untreated |
21 ± 5.2 |
13 ± 3.6 |
2007 |
TA1535 |
Positive |
343 ± 864.2 |
231 ± 476.5 |
2007 |
WP2 uvR |
Solvent/untreated |
26 ± 5.8 |
28 ± 6.4 |
2007 |
WP2 uvR |
Positive |
652 ± 707.9 |
505 ± 535.2 |
2007 |
TA98 |
Solvent/untreated |
21 ± 5.5 |
26 ± 6.0 |
2007 |
TA98 |
Positive |
256 ± 289.7 |
308 ± 280.5 |
2007 |
TA1537 |
Solvent/untreated |
11 ± 3.8 |
13 ± 4.1 |
2007 |
TA1537 |
Positive |
1697 ± 1193.6 |
339 ± 254.4 |
2007 |
TA100 |
Solvent/untreated |
105 ± 18.7 |
101 ± 18.5 |
2008 |
TA100 |
Positive |
487 ± 184.7 |
1138 ± 517.2 |
2008 |
TA1535 |
Solvent/untreated |
23 ± 5.3 |
15 ± 4.8 |
2008 |
TA1535 |
Positive |
210 ± 107.7 |
272 ± 94.9 |
2008 |
WP2 uvR |
Solvent/untreated |
26 ± 5.9 |
29 ± 7.2 |
2008 |
WP2 uvR |
Positive |
548 ± 231.5 |
426 ± 273.9 |
2008 |
TA98 |
Solvent/untreated |
19 ± 4.6 |
26 ± 5.3 |
2008 |
TA98 |
Positive |
155 ± 70.8 |
247 ± 178.2 |
2008 |
TA1537 |
Solvent/untreated |
13 ± 3.7 |
13 ± 3.8 |
2008 |
TA1537 |
Positive |
930 ± 476.2 |
279 ± 101.7 |
2008 |
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.