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EC number: 942-401-1 | 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 23 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Amended by EC No. 761/2009 OJ No. L220, 24 August 2009
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bismuth oxy-iodide bromide
- Cas Number:
- 340181-06-8
- Molecular formula:
- BiOIxBr(1-x), with x = 0.4 - 0.85
- IUPAC Name:
- Bismuth oxy-iodide bromide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - test material: BiOI-BiOBr
- Substance type: inorganic
- Physical state: orange powder
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- pH: 7.5 (50 g/L)
- Stability at higher temperatures: stable (maximum temperature: 280°C, maximum duration 4 hours)
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36.1 - 37.5
- Humidity (%): 80-95
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: approximately 10 mg, 5 μl Milli-Q water to moisten skin. - Duration of treatment / exposure:
- 15 minutes
- Details on study design:
- TEST SITE
EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 10-EKIN-026). This model is a three-dimensional human epidermis model, which consists of adult human derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
REMOVAL OF TEST SUBSTANCE
Washing: phosphate buffered saline - Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
42 hours
SCORING SYSTEM
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 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.
NEGATIVE CONTROL
Phosphate buffered saline (PBS, Invitrogen Corporation, Breda, The Netherlands).
POSITIVE CONTROL
5% (aq) sodium dodecyl sulphate (SDS, Sigma Aldrich, Zwijndrecht, The Netherlands) in PBS.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 8%
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after 15 minutes treatment compared to the negative control tissues was 100%.
The positive control had a mean cell viability after 15 minutes exposure of 8%. 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.
Any other information on results incl. tables
Bismuth oxy-iodide bromide was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that bismuth oxy-iodide bromide did not
interact with MTT.Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An in vitro skin irritation test ((EPISKIN Standard model (EPISKIN-SMTM)) was performed according to OECD guideline and GLP principles. Based on this test it is concluded that bismuth oxy-iodide bromide is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
An in vitro skin irritation test ((EPISKIN Standard model (EPISKIN-SMTM)) was performed according to OECD guideline and GLP principles. The relative mean tissue viability obtained after 15 minutes treatment compared to the negative control tissues was 100%. The positive control had a mean cell viability after 15 minutes exposure of 8%. Since the mean relative tissue viability was above 50% after 15 minutes treatment bismuth oxy-iodide bromide
is considered to be non-irritant.
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