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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 08, 2009 to July 10, 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 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004), approved by the ECVAM Scientific Advisory Committee (ESAC). The GLP compliance is claimed through compliance with UK GLP 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 guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004)
- Deviations:
- yes
- Remarks:
- Interpretation of results
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
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: Pale amber coloured liquid
- Lot/batch No.: 95816206JH-014
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- other: Not applicable
- Preparation of test site:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL
- Duration of treatment / exposure:
- 3, 60 and 240 min.
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- PRE-TEST:
TEST FOR DIRECT MTT REDUCTION: 50 μL of the test material was added to 2.2 mL of a 0.3 mg/mL MTT solution freshly prepared in assay medium. The solution was incubated in the dark at room temperature for 3 h. Untreated MTT solution was used as a control.
PRE-INCUBATION (DAY 0: TISSUE ARRIVAL): 2.2 mL of maintenance medium, warmed to approximately 37 ºC, was pipetted into two wells of the first column of a pre-labelled 12-well plate. Each epidermis unit was transferred into the maintenance medium filled wells (2 units/plate). A different 12-well plate was used for each test material, control and time point. The tissues were incubated at 37 ºC, 5 % CO2 in air for at least 24 h.
MAIN TEST:
APPLICATION OF TEST MATERIAL AND RINSING (DAY 1): 2.2 mL of assay medium, warmed to approximately 37 ºC, was pipetted into 2 wells of the second and third columns of the 12-well plate. The tissues were transferred into the second column. Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 min. Duplicate tissues were treated with the positive and negative control materials for an exposure period of 240 min. 50 μL of the test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.
Negative control: Duplicate tissues, treated with 50 μL of 0.9 % w/v sodium chloride solution served as negative controls.
Positive control: Duplicate tissues, treated with 50 μL of glacial acetic acid served as positive controls.
The treated tissues were kept in a biological safety cabinet at room temperature for the appropriate exposure period. At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material. Each rinsed tissue was placed into the third column of the 12-well plate until all tissues were rinsed.
ABSORBANCE/OPTICAL DENSITY MEASUREMENTS (DAY 2): At the end of the formazan extraction period, each tube was mixed thoroughly on a vortex mixer to produce a homogenous colored solution. For each tissue, duplicate 200 μL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. 200 μL of acidified isopropanol alone was added to the two wells designated as ‘blanks’. The optical density was measured (quantitative viability analysis) at 540 nm (without a reference filter) using the Anthos 2001 microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Relative tissue viability (% of negative control)
- Value:
- 114
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Reversibility: other: Not applicable. Remarks: None. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative tissue viability (% of negative control)
- Value:
- 45
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Reversibility: other: Not applicable. Remarks: None. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative tissue viability (% of negative control)
- Value:
- 12.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 min. Reversibility: other: Not applicable. Remarks: None. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean viability of the test material treated tissues was as follows:
- 240 min. exposure: 12.3 %
- 60 min. exposure: 45.0 %
- 3 min. exposure: 114.0 %
Both treated tissues following the 3 min. exposure period and one treated tissue following the 60 min. exposure period appeared blue, which was considered to be indicative of viable tissue. One treated tissue following the 60 min. exposure period appeared blue/white which was considered to be indicative of semi-viable tissue. Following the 240 min. exposure period the treated tissues appeared white which was considered to be indicative of dead tissue. - Other effects:
- Direct MTT reduction: The MTT solution containing the test material did not turn blue/purple. This was taken to indicate the test material did not reduce MTT.
Positive control: The relative mean tissue viability for the positive control tissues was 19.3 % relative to the negative control tissues following the 240 min. exposure period. The positive control acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Table 1: Mean OD540 values and viabilities for the negative control, positive control and test material
Material |
Exposure period (min.) |
Mean OD540 of duplicate tissues |
Relative mean % viability |
Negative control material |
240 |
0.171 |
100* |
Positive control material |
240 |
0.033 |
19.3 |
Test material |
240 |
0.021 |
12.3 |
60 |
0.077 |
45 |
|
3 |
0.195 |
114 |
* = The mean viability of the negative control tissues is set at 100%
⊕ = Control group shared with Harlan Laboratories Ltd Project number 2787/0008
Table 2: Qualitative evaluation of tissue viability (MTT uptake visual evaluation)
Material |
Exposure period |
Tissue 1 |
Tissue 2 |
Negative control material |
240 |
- |
- |
Positive control material |
240 |
++ |
++ |
Test material |
240 |
++ |
++ |
60 |
- |
+ |
|
3 |
- |
- |
MTT visual scoring scheme of SkinEthic tissues:
- = Blue tissue (viable)
+ = Blue/white tissue (semi-viable)
++ = Tissue completely white (dead)
⊕ = Control group shared with Harlan Laboratories Ltd Project number 2787/0008
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material satisfies the criteria for classification as corrosive to the skin according to EU labelling regulations Commission Directive 2001/59/EC.
- Executive summary:
A study was conducted to evaluate the corrosivity potential of synthetic inositol phosphates using the EPISKINTMin vitro Reconstituted Human Epidermis (RHE) model after treatment periods of 3, 60 and 240 min. This method was designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).
Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 min. At the end of the exposure period, the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into microtubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 μL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm. Data are presented in the form of % viability (MTT reduction in the test material treated tissues relative to negative control tissues).
The relative mean viability of the treated tissues was 114.0, 45.0 and 12.3% after 3, 60 and 240 min. of exposure, respectively.
The test material satisfies the criteria for classification as corrosive to the skin according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “Causes burns” are therefore required. The UN packing group III is also required.
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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