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Diss Factsheets
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EC number: 919-701-6 | CAS number: 503157-00-4
- 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 vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- other: skin tissue
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Test system:
EpiDerm Skin Model (EPI-200, Lot no.: 20532 kit N).
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Test system
- Type of coverage:
- other: EpiDerm Skin Model
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- None
- Duration of treatment / exposure:
- None
- Observation period:
- Acceptability of the assay:
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD540 of the two tissues of the negative control should reasonably be within the laboratory historical control data range.
b) The mean relative tissue viability following 3-minute exposure to the positive control should be <= 30%.
c) The maximum inter-tissue variability (in viability) is 30% between two tissues treated identically.
d) The maximum difference in percentage between the mean viability of two tissues and one of the
two tissues is 15%. - Number of animals:
- None
- Details on study design:
- None
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-hour application viability (percentage of control)
- Value:
- 92
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute application viability (percentage of control)
- Value:
- 88
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- Finally, it is concluded that this test is valid and that FAT 40866/A TE is not corrosive in the in vitro skin corrosion test under the experimental conditions.
- Other effects:
- None
Any other information on results incl. tables
FAT 40866/A TE 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 FAT 40866/A TE did not interact with MTT.
The mean absorption at 540 nm measured after treatment with FAT 40866/A TE.
The mean tissue viability obtained after 3-minute and 1-hour treatments with FAT 40866/A TE compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with FAT 40866/A TE compared to the negative control tissues was
88% and 92% respectively. Because the mean relative tissue viability for FAT 40866/A TE was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment FAT 40866/A TE is considered to be not corrosive.
The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-minute exposure to the positive control was 9%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 20% and the maximum difference in percentage
between the mean viability of two tissues and one of the two tissues was less than 11%. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Finally, it is concluded that this test is valid and that FAT 40866/A TE is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
In vitro skin corrosion test with FAT 40866/A TE using a human skin model. This report describes the ability of FAT 40866/A TE to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of FAT 40866/A TE was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch BOP 04-13 (Lot: BS-MIF 975) of FAT 40866/A TE was a red-brown powder. Skin tissue was moistened with 25 μl of Milli-Q water and 25 mg of FAT 40866/A TE was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 9% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 20% and the maximum difference in percentage between the mean
viability of two tissues and one of the two tissues was less than 11%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with FAT 40866/A TE compared to the negative control tissues was 88% and 92%, respectively. Because the mean relative tissue viability for FAT 40866/A TE was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment FAT 40866/A TE is considered to be not corrosive.
Finally, it is concluded that this test is valid and that FAT 40866/A TE is not corrosive in the in vitro skin corrosion 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.
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