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EC number: 600-548-6 | CAS number: 1042662-40-7
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date 15 February 2017 Experimental completion date 17 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: • Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008,
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3',5'-di-tert-butyl-3-{5-tert-butyl-2-[3-(4-tert-butyl-2-{3',5'-di-tert-butyl-2-hydroxy-5-methyl-[1,1'-biphenyl]-3-yl}phenoxy)propoxy]phenyl}-5-methyl-[1,1'-biphenyl]-2-ol
- EC Number:
- 600-548-6
- Cas Number:
- 1042662-40-7
- Molecular formula:
- C65H84O4
- IUPAC Name:
- 3',5'-di-tert-butyl-3-{5-tert-butyl-2-[3-(4-tert-butyl-2-{3',5'-di-tert-butyl-2-hydroxy-5-methyl-[1,1'-biphenyl]-3-yl}phenoxy)propoxy]phenyl}-5-methyl-[1,1'-biphenyl]-2-ol
Constituent 1
- Specific details on test material used for the study:
- Identification: 2,2'-[propane-1,3-diylbis(oxy)]bis(3",5,5"-tri-tert-butyl-5'-methyl-1,1':3',1"-terphenyl-2’-ol)
Batch: 1502501005
CAS Number: 1042662-40-7
Purity: 98.1%
Physical state/Appearance Sponsor: Solid powder, white, odourless
Physical state/Appearance Envigo: White powder
Expiry Date: 01 February 2025
Storage Conditions: Room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
- Source species:
- other: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Cell type:
- other: Epidermsl
- Cell source:
- other: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Source strain:
- other: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Details on animal used as source of test system:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 14 February 2017
EpiDermTM Tissues (0.63cm2) lot number : 23393
Assay Medium lot number : 020917TME
Upon receipt of the EpidermTM tissues, the sealed 24 well plate was stored in a refrigerator until use. - Justification for test system used:
- Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
This model incorporates several features, which make it advantageous in the study of potential dermal corrosivity. The target cells are epithelial, derived from human skin, and formed into a stratified, cornified epithelium. Test items are applied to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. - Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 25 mg of the test item was added to 1 mL of a freshly prepared 1.0 mg/mL MTT solution. The solution was incubated in the dark at 37 °C, 5% CO2 in air for 60 minutes. Untreated MTT solution was tested concurrently to act as a control.
If the MTT solution containing the test item turns blue/purple relative to the control, the test item was presumed to have reduced the MTT. - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- Immediate observation following exposure
- Number of replicates:
- Two x 24-well plates
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 96.2
- 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:
- 60 minute exposure
- Value:
- 101.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test item did not turn blue/purple. This was taken to indicate the test item did not reduce MTT.
Assessment of Color Interference with the MTT endpoint
The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.
Test Item, Positive Control Item and Negative Control Item
Mean OD562values and viabilities for the negative control, positive control and test item are given in theappendix.
The relative mean viabilities for each treatment group were as follows:
Exposure Period |
Percentage Viability |
||
Negative Control |
Positive Control |
Test Item |
|
3 minute |
100* |
3.5 |
96.2 |
60 minute |
100* |
3.0 |
101.3 |
*The mean viability of the negative control tissues is set at 100%
Quality Criteria
The mean OD562for the negative control treated tissues was 1.806 for the 3‑Minute exposure period and 1.740 for the 60‑Minute exposure period. The negative control acceptance criteria were therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 3.0% relative to the negative control following the 60‑Minute exposure period. The positive control acceptance criterion was therefore satisfied.
In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive to the skin.
- Executive summary:
Introduction
The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 mL samples were transferred to the appropriate wells of a pre-labeled 96‑well plate. The optical density (OD) was measured at 562 nm (OD562).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results
The relative mean viabilities for each treatment group were as follows:
Exposure Period
Percentage Viability
Negative Control
Positive Control
Test Item
3 minute
100*
3.5
96.2
60 minute
100*
3.0
101.3
*The mean viability of the negative control tissues is set at 100%
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion
The test item was considered to be non-corrosive to the skin.
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