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EC number: 233-190-0 | CAS number: 10058-44-3
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- The experimental phases of the study were performed between 26 May 2011 and 25 July 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study is conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiencies. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. The reliability has been amended in accordance with 'practical guide 6: How to report read-across and categories' which states that the maximum reliability for a read-across study is 2. Read-across is justified on the following basis: In accordance with Annex XI, Section 1.5 it is considered to be adequate and reliable to fulfil the information requirements for the endpoint ‘mutagenicity’ by applying a read-across approach from data generated on the substance iron orthophosphate (CAS # 10045-86-0). Both substances are relatively insoluble inorganic ferric (Fe3+) compounds. In conditions where the substances have limited solubility/bioavailability; ionisation to the Fe cation and the orthophosphate cation (iron orthophosphate) or pyrophosphate cation (tetrairon tris(pyrophosphate) will occur. In biological systems (i.e. in the presence of alkaline phosphatase) the pyrophosphate will be broken down into orthophosphate. It is considered that the Fe3+ cation is of most relevance when considering the genotoxic potential of the test material and as iron orthophosphate is slightly more soluble this substance is a good candidate for read-across. The study is considered to be adequate and reliable for the purpose of registration under REACH (Regulation (EC) No. 1907/2006) and for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 20 July 2010, Date of signature: 29 October 2010
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Iron orthophosphate
- EC Number:
- 233-149-7
- EC Name:
- Iron orthophosphate
- Cas Number:
- 10045-86-0
- IUPAC Name:
- iron(3+) phosphate
- Test material form:
- other: 'solid'
- Details on test material:
- Sponsor's identification : IP 27 Iron orthophosphate
Description : Off white solid
Batch number : MV3395
Purity : 100%
Date received : 11 May 2011
Expiry date : 03 March 2014
Storage conditions : Room temperature, in the dark
Constituent 1
Method
- Target gene:
- Thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line.
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Type and identity of media:
RPMI 1640
- Properly maintained:
yes
- Periodically checked for Mycoplasma contamination:
yes
- Periodically checked for karyotype stability:
no
- Periodically "cleansed" against high spontaneous background:
yes
:- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and beta-naphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- the maximum dose level was (10mM) 1508 µg/ml
Vehicle and positive controls were used in parallel with the test item. Solvent (R0) treatment groups were used as the vehicle controls. Ethylmethanesulphonate (EMS), Sigma batch 0001423147 at 400 µg/ml and 150 µg/ml for Experiment 1 and Experiment 2 respectively, was used as the positive control in the absence of metabolic activation. Cyclophosphamide (CP) Acros batch A0164185 at 2 µg/ml was used as the positive control in the presence of metabolic activation - Vehicle / solvent:
- Vehicle(s)/solvent(s) used:
Solvent (R0) treatment groups were used as the vehicle controls.
- Justification for choice of solvent/vehicle:
Formed the best doseable suspension
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent (R0 medium) treatment groups were used as the vehicle controls.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent (R0 medium) treatment groups were used as the vehicle controls.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: :
- Details on test system and experimental conditions:
- The study was conducted according to a method that was designed to assess the potential mutagenicity of the test item on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The method used was designed to be compatible with the OECD Guidelines for Testing of Chemicals No.476 "In Vitro Mammalian Cell Gene Mutation Tests", Method B17 of Commission Regulation (EC) No. 440/2008 of 30 May 2008, the US EPA OPPTS 870.5300 Guideline, and be acceptable to the Japanese EPA/METI/MHLW guidelines for testing of new chemical substances.
Methods. Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test item at eight dose levels, in duplicate, together with vehicle (solvent) and positive controls using 4-Hour exposure groups both in the absence and presence of metabolic activation (2% S9). In Experiment 2, the cells were treated with the test item at six dose levels using a 4 Hour exposure group in the presence of metabolic activation (1% S9) and a 24 Hour exposure group in the absence of metabolic activation.
The dose range of test item was selected following the results of a preliminary toxicity test and for the first experiment was 23.56 to 1508 µg/ml in the absence and presence of metabolic activation. For the second experiment the dose range was 94.25 to1508 µg/ml in the absenceand presence of metabolic activation.
The maximum dose level used in the mutagenicity test was the maximum recommended dose (10mM) of 1508 µg/ml. The vehicle (solvent) controls had acceptable mutant frequency values that were within the normal range for the L5178Y cell line at the TK +/- locus. The positive control items induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. - Evaluation criteria:
Please see ''any other information on materials and methods incl. tables'' section.- Statistics:
- Please see ''any other information on materials and methods incl. tables'' section.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- non-mutagenic
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The dose range of the test item used in the Preliminary Toxicity Test was 5.89 to 1508 µg/ml
A precipitate was observed in all test item dose levels at the end of the exposure periods. Moderate reductions in the Relative Suspension Growth (%RSG) of cells treated with the test item were observed in the 4-Hour exposure groups both in the absence and presence of metabolic activation when compared to the concurrent vehicle control groups. No marked reductions in the Relative Suspension Growth (%RSG) of cells treated with the test item were observed in the 24-Hour exposure group when compared to the concurrent vehicle control group. Because of the reduction in %RSG observed in the 4-hour cultures with and without S9 the maximum dose level selected for the mutagenicity test was 1508 µg/ml, the 10 mM limit dose level
Mutagenicity Test
A summary of the results from the test is presented in attached in Table 1
Experiment 1
The results of the microtitre plate counts and their analysis are presented in Tables 2 to 7.
As was seen in the preliminary toxicity test a precipitate was observed in all test item dose levels and in both exposure groups at the end of the exposure period.
There was evidence of moderate test item-induced toxicity following exposure to the test item in both the absence and presence of metabolic activation, as indicated by the %RSG values (Tables 3 and 6). There was no evidence of reductions in viability (%V) in both the absence and presence of metabolic activation, indicating that residual toxicity had not occurred (Tables 3 and 6). Acceptable levels of toxicity were seen with both positive control substances (Tables 3 and 6).
Neither of the vehicle control mutant frequency values were outside the acceptable range of 50 to 200 x 10-6 viable cells. Both of the positive controls produced marked increases in the mutant frequency per viable cell indicating that the test system was operating satisfactorily and that the metabolic activation system was functional (Tables 3 and 6).
The test item did not induce any statistically significant or dose related (linear-trend) increases in the mutant frequency x 10-6 per viable cell in either the absence or presence of metabolic activation (Tables 3 and 6). A precipitate of test item was observed at and above 23.56 µg/ml.
The numbers of small and large colonies and their analysis are presented in Tables 4 and 7.
Experiment 2
The results of the microtitre plate counts and their analysis are presented in Tables 8 to 13.
As was seen in the preliminary toxicity test a precipitate was observed in all test item dose levels and in both exposure groups at the end of the exposure period.
As was seen previously, there was evidence of moderate toxicity in both the absence and presence of metabolic activation following exposure to the test item, as indicated by the %RSG values (Tables 9 and 12). There was no evidence of reductions in viability (%V) in both the absence and presence of metabolic activation, indicating that no residual toxicity had occurred (Tables 9 and 12). Acceptable levels of toxicity were seen with both positive control substances (Tables 9 and 12).
The 24-Hour exposure without metabolic activation demonstrated that the extended time point had no marked effect on the toxicity of the test item.
Neither of the vehicle control mutant frequency values were outside the acceptable range of 50 to 200 x 10-6 viable cells. Both of the positive controls produced marked increases in the mutant frequency per viable cell indicating that the test system was operating satisfactorily and that the metabolic activation system was functional (Tables 9 and 12).
The test item did not induce any statistically significant or dose related (linear-trend) increases in the mutant frequency x 10-6 per viable cell in either the absence or presence of metabolic activation (Tables 9 and 12). All test item mutation values were within the acceptable range for vehicle control cultures. A precipitate of test item was observed at and above 94.25 µg/ml.
The numbers of small and large colonies and their analysis are presented in Tables 10 and 13. - Remarks on result:
- other: strain/cell type: Thymidine Kinase TK+/-, locus of the L5178Y mouse lymphoma cell line
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Please see Attached ''Tables 1 -10''
Due to the nature and quantitiy of tables it was not possible to insert them into this section.
Table 1 Summary of Results
Table 2 Cell and 96-Well Plate Counts: Experiment 1 (-S9) 4-Hour Exposure
Table 3 Statistical Analysis: Experiment 1 (-S9) 4-Hour Exposure
Table 4 Large and Small Colonies Analysis: Experiment 1 (-S9) 4-Hour Exposure
Table 5 Cell and 96-Well Plate Counts: Experiment 1 (+S9) 4-Hour Exposure
Table 6 Statistical Analysis: Experiment 1 (+S9) 4-Hour Exposure
Table 7 Large and Small Colonies Analysis: Experiment 1 (+S9) 4-Hour Exposure
Table 8 Cell and 96-Well Plate Counts: Experiment 2 (-S9) 24-Hour Exposure
Table 9 Statistical Analysis: Experiment 2 (-S9) 24-Hour Exposure
Table 10 Large and Small Colonies Analysis: Experiment 2 (-S9) 24-Hour Exposure
Table 11 Cell and 96-Well Plate Counts: Experiment 2 (+S9) 4-Hour Exposure
Table 12 Statistical Analysis: Experiment 2 (+S9) 4-Hour Exposure
Table 13 Large and Small Colonies Analysis: Experiment 2 (+S9) 4-Hour Exposure
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Non-mutagenic
Conclusion. The test item did not induce any statistically significant or dose related increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non mutagenic under the conditions of the test. This study is considered to be scientifically justified for use as a key study under Regulation (EC) No. 1907/2006 (REACH).
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