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Diss Factsheets
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EC number: - | CAS number: 37486-69-4
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 August 2010 - 4 October 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions and OECD Guideline 431
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test (adopted April 13, 2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): MTDID 21721, TFEE-5
- Substance type: clear colorless liquid
- Physical state: liquid
- Lot/batch no.: TFEE5-276/12/09-1
- Expiration date of the lot/batch: 12 Dec 2012
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark under nitrogen
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: EpiDerm Skin Model, MatTek Corporation, Ashland, MA, USA
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.0 +/- 1.0
- Humidity (%): 73 - 86
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: 30 August 2010 To: 3 September 2010
Test system
- Type of coverage:
- other: undiluted test substance was added to the cell culture plates on top of the skin tissues
- Preparation of test site:
- other: Skin samples were transferred to plates containing DMEM medium and incubated for 80 min at 37C in 5% CO2, Medium was replaced prior to test article application.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One tissue sample was treated with 50 uL of Milli-Q water (negative control) and one was treated with 50 uL of 8N KOH (positive control).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL/well
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 3 min (two tissues) and 1 h (two tissues)
- Number of animals:
- 4 tissue samples were treated with the test material
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Cell viability was calculated as the percentage of the mean optical density at 540 for the negative control tissue. A test substance is considered corrosive if cell viability compared to the negative control is below 50% after 3 min exposure or below 15% after 1 h exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- ca. 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: other: The relative mean tissue viability after 3-min exposure to TFEE-5 compared to the negative control tissue was 100%.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- ca. 97
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: other: The relative mean tissue viability after 1 hour exposure to TFEE-5 compared to the negative control tissue was 97%.
Any other information on results incl. tables
TFEE-5 was checked for possible direct MTT reduction and none was observed. The cell viability (optical density at 540 nm) for the negative control was within the laboratory historical control range. The mean viability for the positive control following 3 min of exposure was 9%. The maximum inter-tissue variability in viability for tissues treated identically was less than 11% and the maximum difference between the mean viability of two tissues and one of the two tissues was less than 6%. It is 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: other: OECD Test Guideline 431 criteria
- Conclusions:
- TFEE-5 was not corrosive to the skin in this test system
- Executive summary:
OBJECTIVE: The skin corrosion potential of TFEE-5 (MTDID 21721, batch TFEE5-276/12/09-1) was evaluated in an in vitro three dimensional human epidermal skin model (EpiDerm EPI-200). METHODS: This study was conducted in accordance with OECD GLP (1997). The study design was based on OECD 431 (2004) and EC 440/2008, Part B.40 (2008). The test material was tested as received. TFEE-5 was tested for possible direct MTT reduction prior to the study and was shown to not interact with MTT. The in vitro skin was placed in 6-well plates with DMEM media underneath and incubated at 37 C in 5% CO2. TFEE-5 (50 uL) was added to two tissues for a 3 minute exposure and two tissues for a 1 hour exposure. Negative control (Milli-Q water) and positive control (8 N potassium hydroxide) were tested concurrently in a similar manner. After the exposure period the tissues were washed with phosphate buffered saline (PBS) to remove residues. The tissues were then incubated in the presence of MTT for 3 hours at 37 C in a 5% CO2 atmosphere. The tissues were washed with PBS and formazan was extracted with isopropanol overnight at room temperature. The amount of extracted formazan was determined spectrophotometrically at 540 nm. Cell viability was calculated as percentage of the mean of the negative control tissues. A test material is considered corrosive if the relative mean tissue viability is <50% following a 3 minute exposure or <15% following a 1 hour exposure. RESULTS: The negative and positive controls performed as expected which indicated the test was valid. Relative mean tissue viability was 100% and 97% following the 3 minute and 1 hour exposures to TFEE-5, respectively. CONCLUSION: Based on the results of this study, TFEE-5 was not corrosive in the in vitro skin corrosion test.
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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