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Diss Factsheets
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EC number: 931-597-4 | 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 irritation / corrosion, other
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study was conducted between 2 June and 3 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline 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:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 431 (April 13, 2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: the NIH Publication No. 04-4510 dated on May 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- No. B 18-023-01
Test material
- Reference substance name:
- The product from the burning of a combination of carbonaceous materials.
- EC Number:
- 931-597-4
- Molecular formula:
- UVCB substance, not available. View remarks field.
- IUPAC Name:
- The product from the burning of a combination of carbonaceous materials.
- Details on test material:
- - Name of test material: Mixed ash
- Physical state: powder
- Composition range of test material (% (w/w)): Aluminium (Al) 13.07, Calcium (Ca) 45.52 , Iron (Fe) 4.15 , Magnesium (Mg) 3.49, Phosphorus (P) 0.79 , Potassium (K) 2.56, Silicon (Si) 28.07, Sodium (Na) 1.08, Sulphur (S) 1.27.
- The critical minor components examined (mg/kg d.w.): Arsenic (As) 18, Barium (Ba) 670 Cadmium (Cd) 3.6, Copper (Cu) 410, Lead (Pb) 180 and Antimony (Sb) 22.
- Purity test date: the substance is UVCB substance
- Lot/batch No.: MIXED ASH 1-01032010
- Expiration date of the lot/batch: March 2011
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Other: Mixed Ash is named in dossier as Ash. Mixed in the substance name has meant that there have been several (mixed) fuels when producing ash.
Constituent 1
Test animals
- Species:
- other: a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS Reconstructed Human Epidermis RHE/S/17
- Source: SkinEthic Laboratories - 45 rue Saint Philippe - Le Palmeira - 06000 Nice - France
- Age at study initiation: generally 17 days at the start of the experiment
- Pre-incubation time: 1 hour
ENVIRONMENTAL CONDITIONS
Maintenance medium
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: The culture medium, a non-corrosive vehicle
- Controls:
- other: reconstructed epidermis
- Amount / concentration applied:
- TEST MATERIAL, MIXED ASH
- Amount(s) applied (volume or weight with unit): 19.8 mg, grounded powder
Positive control item
- Potassium hydroxide solution at 8 mol/l (SIGMA-Aldrich, Batch 028K07551, Expiry date: 25 Jun 2014) was used as positive control item.
- Amount(s) applied: 39.7 μL
Negative control item
- Sodium chloride solution at 0.9% (Cooper, batch 19BM05GA, Expiry date: Dec 2013) was used as negative control item.
- Amount(s) applied: 39.7 μL
REAGENTS
- Reconstructed Human Epidermis (SkinEthic Laboratories, Batch 10 022A 0507, Expiry date: 07 Jun 2010)
- Maintenance Medium (SkinEthic Laboratories, Batch 1005 0115645, Expiry date: 07 Jun 2010)
- MTT [3-(4,5-dimethylthiazol-2-yl)-2,5diphenyltetrazolium bromide] (SIGMA, batch 027K5308, expiry date: 08 Jun 2012)
- Phosphate buffer saline solution (Gibco, Batch 645392 and 756589, Expriry date: Jun 2011 and Apr 2012, respectively) - Duration of treatment / exposure:
- 1 hour
- Observation period:
- 3 minutes and 1 hour
- Number of animals:
- 15 units of reconstructed epidermis
- Details on study design:
- See text in "Any other information on materials and methods" part 'Main study'.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Cell viability as %
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- ca. 97
- Max. score:
- 100
- Reversibility:
- no data
- Irritation parameter:
- other: Cell viability as %
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 100
- Max. score:
- 100
- Reversibility:
- no data
- Irritant / corrosive response data:
- See below.
Any other information on results incl. tables
Preliminary study
Since the MTT solution did not turn blue/purple when in contact with the test item for 1 hour (step 1), no interference between MTT and test item was concluded. For this reason, the second step of the preliminary study was not performed.
Main study
Mean results are presented in Table 3. Individual results are presented in Table 4.
Table 3 Effect on optical density (mean values)
Treatment | T=3min | T=1H | |
Negative control | Mean | 1.387 | 1.340 |
SEM | 0.021 | 0.073 | |
N | 9 | 9 | |
MIXED ASH | Mean | 1.346 | 1.405 |
SEM | 0.039 | 0.017 | |
N | 9 | 9 | |
P | NS | NS | |
Positive control | Mean | NA | 0.000 |
SEM | NA | 0.001 | |
N | 0 | 9 | |
P | (n<5) | ** | |
Treshold | NA | 0.144 |
NS:P>0.05, **:P60.01, when compared with control group
Analysis of variance with Dunnet's test if P <=0.05
(n<5): not not included in statistical analysis because of insufficient number
Threshold: smallest difference being statistically significant (P <= 0.05) estimated from Dunnet's test
Table 4 Optical density and cell viability
Treatment | Optical density T=3min | Viability (%) T=3min | Optical density T=1H | Viability (%) T=1H |
Negative control | 1.387 | 100 | 1.340 | 100 |
MIXED ASH | 1.346 | 97 | 1.405 | 100 |
Positive control | NA | NA | 0.000 | 0 |
After 1 hour of treatment, the positive control item showed a cell viability percentage of 0.2%. As expected and according to the OECD Guideline No.431, the positive control item was classified as corrosive. This result validated the ongoing sensitivity of the method used.
After 3 minutes and 1 hour of treatment with the undiluted test item MIXED ASH, the percentage of cell viability was 97.1% and 100% respectively as summarised in Table 6:
Table 6 Prediction of corrosivity
Treatment | Cell viability (%) T=3min | Cell viability (%) T=1H | Classification |
Negative control (NaCl 0.9%) | 100 | 100.0 | Non-corrosive |
Test item MIXED ASH (undiluted) | 97 | 100.0 | Non-corrosive |
Positive control (KOH 8 mol/L) | / | 0.2 | Corrosive |
CONCLUSION
Under the experimental conditions adopted, test item MIXED ASH was classified as noncorrosive on the SkinEthic human reconstructed epidermis.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Ash was found to be non-corrosive.
- Executive summary:
Skin corrosivity of Ash was studied with an in vitro method Human Skin Model Test (OECD 341). In the test, skin epidermis was exposed to grounded Ash powder. Indications of corrosivity were observed after 3 minutes and 1 hours after the exposure. After the exposure time, tissues were rinsed and further incubated with MTT medium. After this incubation step, tissues were washed with a buffer solution and optical density of formazan extract was determined spectrophotometrically. No evidence of corrosivity was observed.
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