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Diss Factsheets
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EC number: 273-748-0 | CAS number: 69012-49-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-07-07 to 2009-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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: EU method B.46 (in vitro skin irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material: Sinter ore
- Physical state: Solid
- Substance type: Dark grey rocks
- Composition of test material, percentage of components: Certificate of analysis included within report
- Lot/batch No.: not reported
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- other: EPISKIIN™ Reconstituted Human Epidermis model
- 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: Positive and negative controls were included in study
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ± 2 mg
VEHICLE
Test material was used as supplied - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 hours
- Number of animals:
- The test was performed in triplicate
- Details on study design:
- APPLICATION OF TEST MATERIAL
- Area of exposure: The test material was applied topically to the reconstituted epidermis ensuring uniform coverage. The epidermis surface had been moistened with 5 µL of sterile distilled water to improve contact between the solid test material and the epidermis.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period each tissue was rinsed with a Phosphate Buffered Saline solution containing Ca2+ and Mg2+ before incubating for approximately 42 hours at 37 °C in 5% CO2 air
- Time after start of exposure: 15 minutes
SCORING SYSTEM:
At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes 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.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Relative tissue viability %
- Value:
- >= 92.39 - <= 101.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Please refer to table 1 for tabulated results including control.
- Other effects / acceptance of results:
- The relative mean viability of the test material treated tissues was 97.3% after a 15-minute exposure.
QUANTITATIVE MTT ASSESSMENT (percentage tissue viability):For the test material, the relative mean tissue viabilities were compared to the mean of the negative control treated tissues (n = 3). The relative mean viabilities were calculated in the following way:
% Relative mean viability = (mean OD540 of test material/mean OD540 of negative control) x 100
The test material was found not to directly reduce MTT.
Any other information on results incl. tables
Table 1: Mean OD540 values and % viabilitiesb for the negative control material, positive control material and test material
Material |
OD540of tissues |
Mean OD540of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability % |
Relative mean % viability |
± SD of % viability |
Negative control material |
0.826 |
0.756 |
0.061 |
109.3 |
100a |
8.15 |
0.710 |
93.9 |
|||||
0.733 |
97.0 |
|||||
Positive control material |
0.069 |
0.074 |
0.012 |
9.1 |
9.7 |
1.55 |
0.065 |
8.6 |
|||||
0.087 |
11.5 |
|||||
Test material |
0.744 |
0.736 |
0.035 |
98.4 |
97.3 |
4.59 |
0.698 |
92.3 |
|||||
0.766 |
101.3 |
aThe mean viability of the negative control tissues is set at 100%;bData are presented in the form of % viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Table 2: Qualitative evaluation of tissue viability (MTT uptake visual evaluation)
Material |
Tissue 1 |
Tissue 2 |
Tissue 3 |
Negative control Material |
- |
- |
- |
Positive Control Material |
++ |
++ |
++ |
Test Material |
- |
- |
- |
MTT visual scoring scheme:
- - = blue tissue (viable)
- + = blue/white tissue (semi-viable)
- ++ = tissue is completely white (dead)
Quality criteria
The quality criteria required for acceptance of results in the test were satisfied, i.e. positive control and negative control acceptance criteria.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria.
- Conclusions:
- The test material was considered to be a non-irritant to the reconstituted human epidermis model EPISKIN™.
- Executive summary:
The skin irritation potential of the test material was assessed in vitro using a method equivalent to EU Method B.46 and in compliance with GLP using an EPISKIIN™ Reconstituted Human Epidermis model.
The relative mean viability of the test material treated tissues was 97.3 % after a 15-minute exposure and was therefore considered to be a non-irritant.
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.
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