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EC number: 947-151-7 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization. Study is adequate for assessment with acceptable restrictions. Stability of the test material was the responsibility of the sponsor and therefore an expiry date was not reported for the batch of test material used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- of 2000
- 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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- biphenyl-4,4'-diyl tetraphenyl bis(phosphate)
- EC Number:
- 700-627-6
- Cas Number:
- 17270-01-8
- Molecular formula:
- C36H28O8P2
- IUPAC Name:
- biphenyl-4,4'-diyl tetraphenyl bis(phosphate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: essential amino acid requiring strains
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from male Sprague Dawley rats treated by oral gavage on 3 consecutive days with phenobarbitone and β-naphthoflavone (80 and 100 mg/kg/day, respectively) for enzyme induction. (S9 mix = 10% liver S9 in standard cofactors)
- Test concentrations with justification for top dose:
- Preliminary Toxicity Study (TA100, WP2 uvrA without or with metabolic activation (S9))
Doses: 0 (vehicle control); 0.15; 0.5; 1.5; 5; 15; 50; 150; 500; 1500 and 5000 μg/plate
Experiments 1 and 2,
(direct plate incorporation method, TA 98, TA100, TA1535, TA1537, WP2 uvrA, each without and with metabolic activation (S9) tested in triplicate)
Doses: 0 (vehicle control); 50; 150; 500; 1500 and 5000 μg/plate. - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO) (solvent was dried using molecular sieves, sodium alumino-silicate i.e. 2 mm pellets, nominal pore diameter 4 A)
Justification for choice of solvent/vehicle:
Test material was insoluble in water according to information of the sponsor, but it was soluble in dimethyl sulphoxide (DMSO) at the required concentration of 50 mg/mI in solubility checks performed in this laboratory. Vehicle (DMSO) control plates produced counts of revertant colonies within the normal range.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- In addition, sterility controls were included to assess sterility of the test material
- Negative solvent / vehicle controls:
- yes
- Remarks:
- without and with S9 mix
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Positive control substances for tests without metabolic activation (S9 mix). All of them are well established reference mutagens.
- Untreated negative controls:
- yes
- Remarks:
- In addition, sterility controls were included to assess sterility of the test material and S9 mix
- Negative solvent / vehicle controls:
- yes
- Remarks:
- without and with S9 mix
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene for TA 100, TA 1535, TA 1537 & WP2 uvrA
- Remarks:
- Positive control substance for tests with metabolic activation (S9 mix). Both are well established reference mutagen.
- Details on test system and experimental conditions:
- Direct Plate Incorporation Tests, both without and with metabolic activation, were performed in both experiments (Experiments 1 and 2).
Prior to use the master strains were checked for characteristics, viability and spontaneous reversion rate and were all found to be satisfactory.
The following positive controls were used to check mutability of the bacteria and activity of the S9 mix:
Without metabolic activation (S9 mix):
N-ethyl-N'-nitro-N-nitrosoguanidine:
- 2 μg/plate: - strain WP2 uvrA,
- 3 μg/plate: - strain TA 100,
- 5 μg/plate: - strain TA 1535
9-Aminoacridine:
- 80 μg/plate: - strain TA 1537
4-Nitroquinoline-1-oxide:
- 0.2 μg/plate: - strain TA 98
With metabolic activation (S9 mix):
2-Aminoanthracene:
- 1 μg/plate: - strain TA 100,
- 2 μg/plate: - strains TA 1535 and TA 1537,
- 10 μg/plate: - strain WP2 uvrA,
Benzo(a)pyrene:
- 5 μg/plate: - strain TA 98 - Evaluation criteria:
- The test chemical was considered to exhibit mutagenic activity in this assay if the following criteria were met:
A 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 in the presence and/or absence of the S9 microsomal enzymes.
The test chemical was considered to be non-mutagenic (negative) if the above criteria were not met.
Positive controls were considered to be valid if their mean revertant count (per strain without or with metabolic acitvation) was at least two times the respective vehicle control value. - Statistics:
- The study report does not clearly indicate whether or not the data were analysed for statistically significant differences of revertant counts although reference is given to:
Kirkland DJ (Ed) 1989: Statistical Evaluation of Mutagenicity Test Data.
UKEMS Sub-committee on Guidelines for Mutagenicity Testing, Report - Part Ill, Cambridge University Press.
Comment:
However, the study report states that biological relevance of the results would be considered first and the study result was unequivocal. Statistical analysis of the data was not required to determine the result of the test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Preliminary Toxicity study
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Preliminary Toxicity study
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Preliminary Toxicity study
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Preliminary Toxicity study
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- S9 mix used in each experiment and the test material formulations tested for sterility in the preliminary toxicity test showed no evidence of contamination.
An opaque film was noted from 1500 µg/plate and an associated oily precipitate observed at 5000 µg/plate. Neither of these observations interfered with the scoring of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- negative without and with metabolic activation (S9 mix)
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