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EC number: 222-883-3 | CAS number: 3648-18-8
- 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:
- 02 October 2012 to 08 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dioctyltin dilaurate
- EC Number:
- 222-883-3
- EC Name:
- Dioctyltin dilaurate
- Cas Number:
- 3648-18-8
- Molecular formula:
- C40-H80-O4-Sn
- IUPAC Name:
- dioctyltin dilaurate
- Test material form:
- other: liquid (undefined)
- Details on test material:
- Storage: Room temperature in the dark.
State: Yellow liquid.
Constituent 1
Test system
- Amount / concentration applied:
- 10 µL of test material was applied topically.
- Duration of treatment / exposure:
- 15 minutes.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Relative viability (%)
- Value:
- 101.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Max. score: 100.0. (migrated information)
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.
Main Test - Results
The relative mean viability of the test material treated tissues was 101.8 % after a 15 minute exposure period.
Table 1: Results
Item |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 (%) |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relaive mean viability (%) |
|
Negative control item |
0.727 |
0.725 |
0.044 |
100.3 |
100* |
6.1 |
|
0.680 |
93.8 |
||||||
0.768 |
105.9 |
||||||
Positive control item |
0.070 |
0.053 |
0.015 |
9.7 |
7.3 |
2.1 |
|
0.046 |
6.3 |
||||||
0.043 |
5.9 |
||||||
Test material |
0.785 |
0.738 |
0.110 |
108.3 |
101.8 |
15.2 |
|
0.612 |
84.4 |
||||||
0.816 |
112.6 |
SD = standard deviation
* = the mean viability of the negative control tissues is set at 100 %
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 7.3 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 2.1 %. The positive control criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.725 and the standard deviation value of the percentage viability was 6.1 %. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 15.2 %. The test material acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material was considered to be a non-irritant.
- Executive summary:
The skin irritation potential of the test material was determined in vitro, in accordance with standardised guidelines OECD 439 and EU Method B.46 using the EPISKIN™ Reconstructed Human Epidermis (RHE) Model.
During the study triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. 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).
Under the conditions of the study, the relative mean viability of the test material treated tissues was 101.8 % after the 15 minute exposure period. The quality control criteria required for acceptance of results were satisfied and the test material was concluded to be a non-irritant to the skin.
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