Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 700-206-7 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 24, 2009 to April 22, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The procedures performed in this study were based on OECD Guideline 471, EU Method B.13/14, USA, EPA (TSCA) OPPTS harmonised guidelines, Japanese regulatory guidelines including METI, MHLW and MAFF. The GLP compliance is claimed through compliance with UK Good Laboratory Practice standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)].
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Inositol phosphates
- EC Number:
- 700-206-7
- Molecular formula:
- As this substance is a UVCB substance and consists varying degree of components, a single molecular formula is not applicable
- IUPAC Name:
- Inositol phosphates
- Reference substance name:
- Synthetic inositol phosphates
- IUPAC Name:
- Synthetic inositol phosphates
- Details on test material:
- - Name of test material (as cited in study report): Synthetic Inositol phosphates
- Physical state: Amber coloured liquid
- Analytical purity: 24-31% Inositol phosphates in water
- Lot/batch No.: 95816206JH-012
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% liver S9 fraction in standard co-factors
- Test concentrations with justification for top dose:
- Preliminary test (Range-finding test): 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1,500 and 5,000 μg/plate
Mutation test:
Experiment 1 & 2: 50, 150, 500, 1,500 and 5,000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
- Justification for choice of solvent/vehicle: Test material was fully miscible (50 mg/mL) in sterile distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Concurrent negative controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation (S9)
Migrated to IUCLID6: 3 μg/plate for TA100, 5 μg/plate for TA1535 and 2 μg/plate for WP2uvrA-
- Untreated negative controls:
- yes
- Remarks:
- Concurrent negative controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation (S9)
Migrated to IUCLID6: 80 μg/plate for TA1537
- Untreated negative controls:
- yes
- Remarks:
- Concurrent negative controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation (S9)
Migrated to IUCLID6: 0.2 μg/plate for TA98
- Untreated negative controls:
- yes
- Remarks:
- Concurrent negative controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation (S9)
Migrated to IUCLID6: 5 μg/plate for TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 1 μg/plate for TA100, 2 μg/plate for TA1535 and TA1537, and 10 μg/plate for WP2uvrA-
- Remarks:
- with metabolic activation (S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (direct plate incorporation)
DURATION
- Preincubation period: Not applicable
- Exposure duration:
Preliminary test: 48 h (with and without S9) at 37 °C
Mutation test:
Experiment 1 & 2: 48 h (with and without S9) at 37 °C
- Expression time (cells in growth medium): 48 h
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
NUMBER OF REPLICATIONS: Triplicate
- Evaluation criteria:
- Criteria for determining positive result: Dose-related increase in the frequency of revertant colony 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.
A test material was considered non-mutagenic (negative) in the test system if the above criteria were not met. - Statistics:
- The experimental data was analysed using UKEMS recommended statistical guidelines.
Results and discussion
Test resultsopen allclose all
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not applicable
- Effects of osmolality: Not applicable
- Evaporation from medium: Not applicable
- Water solubility: 50 mg/mL
- Precipitation: No
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES:
The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5,000 μg/plate.
- The test material caused no visible reduction in the growth of the bacteria at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5,000 μg/plate.
- No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
- No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA: No comparison performed.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Not applicable - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test material was non-toxic to the strains (TA100 and WP2uvrA-) of bacteria.
Sterility check of S9-mix:
The test material formulation and S9-mix used in this experiment were both shown to be sterile.
Table 1: Numbers of revertant colonies for the toxicity assay
With (+) or without (-) S9-mix |
Strain |
Dose (μg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
99 |
101 |
104 |
90 |
109 |
103 |
109 |
111 |
131 |
93 |
118 |
+ |
TA100 |
104 |
94 |
108 |
119 |
111 |
106 |
91 |
98 |
99 |
88 |
87 |
- |
WP2uvrA- |
21 |
20 |
22 |
24 |
32 |
27 |
19 |
34 |
31 |
21 |
18 |
+ |
WP2uvrA- |
30 |
44 |
19 |
35 |
25 |
37 |
39 |
29 |
26 |
35 |
24 |
Mutation test:
No visible reduction in the growth of the bacterial background lawn was observed at any dose level. Therefore, the test material was tested upto the maximum recommended dose level of 5,000 µg/plate.
Neither the test material precipitate nor any significant increases in the frequency of revertant colonies were observed on the plates of any of the doses tested in either the presence or absence of S9-mix.
Significant increases in the frequency of revertant colonies were observed with all the positive control chemicals which confirmed the activity of the S9-mix and the sensitivity of the bacterial strains.
Table 2: Test Results: Experiment 1 – Without Metabolic Activation (see attached PDF titled 'Genetic toxicity-in vitro' page no. 16)
Table 3: Test Results: Experiment 1 – With Metabolic Activation (see attached PDF titled 'Genetic toxicity-in vitro' page no. 17)
Table 4: Test Results: Experiment 2 – Without Metabolic Activation (see attached PDF titled 'Genetic toxicity-in vitro' page no. 18)
Table 5: Test Results: Experiment 2 – With Metabolic Activation (see attached PDF titled 'Genetic toxicity-in vitro' page no. 19)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
A study was conducted to determine the potential mutagenicity of synthetic inositol phosphates using a bacterial/microsome test system. The method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFFand the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC) Number 440/2008 of 30 May 2008 and the USA, EPA (TSCA) OPPTS harmonised guidelines.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was 50 to 5000 μg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations.
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 μg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
The test material was therefore considered to be non-mutagenic under the conditions of this test.
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.