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Diss Factsheets
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EC number: 239-581-2 | CAS number: 15535-79-2
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 November 2012 to 29 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to the standardised guidelines OECD 431 and EU Method B.40 and in line with GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 15335-79-2
- Cas Number:
- 15335-79-2
- IUPAC Name:
- 15335-79-2
- Test material form:
- other: solid (unspecified)
- Details on test material:
- - Appearance: pale brown solid
- Storage conditions: room temperature in the dark
Constituent 1
Test system
- Amount / concentration applied:
- 20 mg of the solid test material was applied topically.
The test material was prepared by cutting suitable sized pellets for dosing onto the tissue surface. - Duration of treatment / exposure:
- 3, 60 and 240 minutes.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Relative mean viability (%)
- Value:
- 104
- Remarks on result:
- other:
- Remarks:
- Basis: mean duplicate tissues. Time point: 240 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean viability (%)
- Value:
- 124.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean duplicate tissues. Time point: 60 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean viability (%)
- Value:
- 110.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean duplicate tissues. Time point: 3 minutes. (migrated information)
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test material did not turn blue. This was taken to indicate the test material did not reduce MTT.
Test Material, Positive Control Item and Negative Control Item
Mean OD540 values and viabilities for the negative control, positive control and test material are given in Table 2.
The relative mean viability of the test material treated tissues was as follows:
240 minutes exposure: 104.0 %
60 minutes exposure: 124.5 %
3 minutes exposure: 110.5 %
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 2.4 % relative to the negative control treated tissues following the 240 minute exposure period. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.868. The negative control acceptance criterion was therefore satisfied.
Table 2: Mean OD540 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
Exposure Period (Minutes) |
Mean OD540 of Duplicate Tissues |
Relative Mean Viability % |
Negative Control Item |
240 |
0.868 |
100* |
Positive Control Item |
240 |
0.021 |
2.4 |
Test material |
240 |
0.903 |
104.0 |
60 |
1.081 |
124.5 |
|
3 |
0.959 |
110.5 |
*The mean viability of the negative control tissues is set at 100 %.
Applicant's summary and conclusion
- Interpretation of results:
- other: Under the conditions of the test, the test material can be considered not to require a classification for corrosion. Irritancy cannot be assessed with this method.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be Non-Corrosive to the skin.
- Executive summary:
The purpose of the test was to evaluate the corrosivity potential of the test material using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model. This method was designed to be compatible with the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004) and Method B.40 of Commission Regulation (EC) No. 440/2008.
Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labelled 96 well plate. The optical density (OD) was measured at 540 nm (OD540).
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
The relative mean viability of the test material treated tissues were:
240 minutes exposure: 104.0 %
60 minutes exposure: 124.5 %
3 minutes exposure: 110.5 %
Since the relative mean viability was ≥ 35 % at 240 minutes, the test material was considered to be non-corrosive to skin.
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