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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-732-3 | CAS number: 69012-32-4 By-product of smelting of phosphate rock, silica and coke in manufacture of phosphorus.
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 February 2010 - 08 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, December 2009, under GLP Standards, and QA.
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, December 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 "In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test ", August 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Slags, phosphorus-manufg.
- EC Number:
- 273-732-3
- EC Name:
- Slags, phosphorus-manufg.
- Cas Number:
- 69012-32-4
- Molecular formula:
- not applicable due to the multi constituent mineral structure of the substance
- IUPAC Name:
- aluminium(3+) heptacalcium magnesium(2+) λ²-iron(2+) disodium tris([(trioxidosilyl)oxy]silanetris(olate)) oxosilanebis(olate) hydroxysilanoylolate difluoride
- Details on test material:
- - Name of test material (as cited in study report): Phosphorous slag
- Physical state: powder
- Analytical purity: confidential
- Lot/batch No.: not indicated
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- other: not relevant: in vitro test
- Strain:
- other: Human skin tissue: EPISKIN Standard Model
- Details on test animals or test system and environmental conditions:
- EPISKIN STANDARD MODEL
- Source: SkinEthic Laboratories, Nice, France
On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 2 hours and 45 minutes at 37°C. The level of Maintenance Medium was just beneath the tissue.
ENVIRONMENTAL CONDITIONS: All incubations, with the exception of the test substance incubation of 15 minutes at room temperature:
- Temperature (°C): 37.0 ± 1.0 (actual range 37.0 - 37.6)
- Humidity (%): 80 - 100 (actual range 65 - 90),
- 5.0 ± 0.5% CO2 in air
- Photoperiod: dark
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: Skin tissue was moistened with 5 ul of Milli-Q water to ensure close contact to the tissue and at least 10 mg of the solid test substance was applied directly on top of the skin tissue. Phosphorous slag was spread to match the size of the tissue.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Phosphate buffered saline (PBS)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): at least 10 mg
POSITIVE CONTROL: 5% (aq) Sodium dodecyl sulphate (SDS) - 10 ul
NEGATIVE CONTROL: Phosphate buffered saline (PBS) - 10 ul - Duration of treatment / exposure:
- Exposure: 15 minutes
Incubation: 42 ± 2 hours - Observation period:
- Not applicable
- Number of animals:
- 9 skin tissues: negative control, positive control and test item: 3 each
- Details on study design:
- TEST SITE: EXPOSURE OF THE TISSUES
Skin tissue was moistened with 5 ul of Milli-Q water to ensure close contact to the tissue and at least 10 mg of the solid test substance was applied directly on top of the skin tissue into 12-well plates. Phosphorous slag was spread to match the size of the tissue.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tissues were washed with phosphate buffered saline to remove residual test substance
- Time after start of exposure: 15 minutes
SCORING SYSTEM: Determination of the cytotoxic (irritancy) effect is performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.
For Evaluation Criteria see 'Other information on materials and methods'.
TOOL USED TO ASSESS SCORE: The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the Multiskan Spectrum (absorption/optical density measurement: OD570).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Absorption (Optical Density - OD570)
- Value:
- ca. 0.747
- Remarks on result:
- other:
- Remarks:
- Basis: mean Triplicate exposures. Max. score: 0.889. Reversibility: other: not applicable. Remarks: SD: ± 0.003; The values are corrected for the non-specific MTT reaction. (migrated information)
- Irritation / corrosion parameter:
- other: other: Tissue viability
- Value:
- ca. 86
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Reversibility: other: not applicable. Remarks: percentage of negative control. (migrated information)
In vivo
- Other effects:
- Phosphorous slag was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because a color change was observed it was concluded that Phosphorous slag did interact with MTT. In addition to the normal procedure, 3 killed tissues treated with test substance and 3 killed non treated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by Phosphorous slag was 13% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test substance treated viable tissues.
Any other information on results incl. tables
The positive control had a mean cell viability of 20% after 15 minutes exposure. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The relative mean tissue viability obtained after 15 minutes treatment with Phosphorous slag compared to the negative control tissues was 86%. Since the mean relative tissue viability for Phosphorous slag was above 50% after 15 minutes treatment Phosphorous slag is considered to be non-irritant. It is concluded that this test is valid and that Phosphorous slag is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
This report describes the ability of Phosphorous slag to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SM)). The possible skin irritation potential of Phosphorous slag was tested through topical application for 15 minutes. The study procedures described in this report were based on the OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, December 2009.
Skin tissue was moistened with 5 ul Milli-Q water and at least 10 mg of Phosphorous slag was applied directly on top of the skin tissue. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. As phosphorous slag directly interacted with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT), 3 killed test substance treated tissues and 3 killed non treated tissues were used for the cytotoxicity evaluation with MTT, in addition to the normal procedure.
The non-specific reduction of MTT by Phosphorous slag was 13% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test substance treated viable tissues. Skin irritation is expressed as the remaining cell viability after exposure to the test substance The relative mean tissue viability obtained after 15 minutes treatment with Phosphorous slag compared to the negative control tissues was 86%.
Since the mean relative tissue viability for Phosphorous slag was above 50% after 15 minutes treatment Phosphorous slag is considered to be non-irritant. The positive control had a mean cell viability after 15 minutes exposure of 20%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that Phosphorous slag is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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.