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EC number: 700-567-0 | CAS number: 1231728-34-9
- 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:
- 2010-11-24 to 2010-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tin(2+) bis(3,5,5-trimethylhexanoate)
- EC Number:
- 700-567-0
- Cas Number:
- 1231728-34-9
- Molecular formula:
- C18H34O4Sn
- IUPAC Name:
- tin(2+) bis(3,5,5-trimethylhexanoate)
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis model EpiDerm™ (EPI-200-SIT)
- Details on test animals or test system and environmental conditions:
- EpiDerm™ is cultured from normal human keratinocytes on inert polycarbonate filters.
Test system
- Amount / concentration applied:
- 30 µl
- Duration of treatment / exposure:
- Quality control 2 h (± 15 min) (Triton X-100, 1 % solution)
Positive control 60 min (± 1 min) (SDS 5 % solution)
Negative control 60 min (± 1 min) Ultra Pure Water
Test substance 60 min (± 1 min) undiluted - Observation period:
- after washing process post incubation period of 42 h
- Number of animals:
- The test was performed in triplicate
Results and discussion
In vivo
- Irritant / corrosive response data:
- Test substance: mean viability 84.1 (+/- 7.2) %
Negative control: mean viability 100 (+/- 1.2) %
Positive control: mean viability 7.8 (+/- 1.3) %
Any other information on results incl. tables
Test substance: mean viability 84.1 (+/- 7.2) %
Negative control: mean viability 100 (+/- 1.2) %
Positive control: mean viability 7.8 (+/- 1.3) %
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (in triplicate)
resulted in a mean cell viability of 84.1 % when compared to the corresponding negative conrol. According to the evaluation scheme of OECD test
guideline 439 the test substance has to be predicted as not irritating to the skin. - Executive summary:
The skin irritating potential of the test substance hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) has been investigated using an in-vitro reconstructed human epidermal model (RHE), according to OECD guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, July 2010).
EpiDerm™ RHEs were topically exposed to 30µL of the test substance for 60 min (± 1 min). The cell viability was determined after an additional 42 h (± 2 h) post incubation period. For the analysis of the tissue viability the Standard MTT Assay was used. The viability of the negative control (UPW) was set to 100%.
The topical application of the test substance to stratum corneum of the RHE (each in triplicate) resulted in a mean cell viability of 84.1% related to the corresponding negative control.
Residual test substance adhered to the reconstructed epidermis after completion of the rinsing procedure may have had an impact on the overall test performance due to the chemically reducing properties of the test substance towards the MTT reagent. A control with freeze killed tissue, to identify possible interference, was not included in this study. However, according to the study authors the validity of the study was not affected.
The functionality of the used test system was demonstrated by topical application of Triton X-100 (1% aqueous solution) in a quality control, resulting in a mean cell viability of 95.5 % after 2 h (± 15 min) exposure. The sensitivity and accuracy of the used test system has been demonstrated with the reference substance SDS (5% aqueous solution). A mean cell viability of 7.8 % in relation to the corresponding negative control UPW was determined.
In conclusion hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) has to be predicted as not irritating to skin when the current prediction model is applied according to the international OECD Test Guideline 439.
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