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EC number: 939-200-6 | CAS number: -
- 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:
- 1-3 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: An in vitro study, according to OECD test guidelines and GLP compliant, based on the EPISKIN model has been completed. The data are considered reliable for completing this endpoint
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- In vitro skin irritation test based on reconstructed human epidermis model
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate
- EC Number:
- 939-200-6
- IUPAC Name:
- Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate
- Reference substance name:
- Sodium Isobutyrate Solution
- IUPAC Name:
- Sodium Isobutyrate Solution
- Test material form:
- other: reaction mass semi-liquid solution
- Details on test material:
- - Name of test material (as cited in study report): Sodium Isobutyrate Solution
- Substance type:Reaction mass
- Physical state: Light yellow semi liquid
- Analytical purity: 86.5%
- Composition of test material, percentage of components: confidential information
- Purity test date: 12 April 2013
- Lot/batch No.: W195_02
- Expiration date of the lot/batch: 17 October 2013
- Storage condition of test material:room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- other: iin vitro - reconstructed human epidermis model
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Test model - EPISKIN reconstructed human epidermis model. EPISKIN-SM is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues is compared to negative controls and expressed as a percentage. The % reduction in viability is used to predict the irritation potential of the material under investigation. The in vitro assay is an accepted alternative to the conduct of a rabbit skin irritation assay.
IN-LIFE DATES: From: 1 May 2013 To: 3 May 2013
Test system
- Type of coverage:
- other: in vitro assay
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- 20 mg of the semi-liquid test material were applied to each epidermal surface in the test wells.
50 µL of phosphate buffered saline negative control applied to three control skin units
50 µL of 5% SDS applied to three positive control skin units - Duration of treatment / exposure:
- On Day -1 maintenance medium was pre-warmed to 37°C and applied to the assay plate wells (2 mL per well). The epidermal constructs were overlaid on the medium and the prepared wells were incubated overnight at 37°C.
On day 0, 20 mg of test material was applied to the epidermal surface of three prepared wells. 50 µL of PBS or SDS applied to each of three wells to act as negative or positive controls. The plates were exposed for 15 minutes at circa 25°Cand then the membranes were removed and rinsed in PBS to remove test material residues. The epidermal surface was then vacuum-cleaned. The epidermal unit was replaced onto fresh medium and incubated for 42 hours at 37°C.
After 42 hours the epidermal units were transferred to wells filled with MTT solution and the units incubated or a further 3 hours at 37°C.
Formazan extraction occurred at the end of the MTT incubation. A disk of epidermis obtained by biopsy punch was separated into the epidermal and collagen matrix fractions and each was placed into 500 µL of acidified isopropanol. Formazan extraction proceeded during a two-hour incubation. Following extraction the absorbance/optical density (OD) was recorded for each sample using spectrophotometry at 540 nm. - Observation period:
- 42 hours
- Number of animals:
- Not applicable. Three replicate wells prepared for test material and three each for the positive and negative controls
- Details on study design:
- Test model - EPISKIN reconstructed human epidermis model. EPISKIN-SM is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues is compared to negative controls and expressed as a percentage. The % reduction in viability is used to predict the irritation potential of the material under investigation. The in vitro assay is an accepted alternative to the conduct of a rabbit skin irritation assay.
EPISKIN-SM (Source: SkinEthic, France, Batch No.: 13-EKIN-016, Expiry date: 06 May 2013) is a three-dimensional human epidermis model. Adult human-derived epidermal keratinocytes are seeIts use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viabilityded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
The negative control use was phosphate buffered saline (PBS). The positive control was 5% sodium dodecyl sulphate in distilled water.
Control checks were included fordetermination of false viability, for possible direct MTT reduction by the test material and for any colouring potential arising directly from coloured test materials that mayhave affected the OD from the spectrophotometry fluid or by direct staining of the tissues..
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: mean OD as an indicator of cell viability
- Value:
- 98
- Remarks on result:
- other:
- Remarks:
- Basis: other: percent relative viability. Time point: 42 hours. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Following exposure to Sodium Isobutyrate Solution, the mean relative viability value of the treated skins was 98% ; the substance was not irritating. All validity criteria were within acceptable limits and therefore the study can be considered as valid. (migrated information)
In vivo
- Irritant / corrosive response data:
- Following exposure to Sodium Isobutyrate Solution, the mean relative viability value of the treated skins was 98%. THe test substance was not therefore irritating to skin. All validity criteria were within acceptable limits and therefore the study can be considered as valid
Any other information on results incl. tables
The results of the optical density (OD) measured at 540 nm of each extract and the calculated % viability of the cells is presented in Table 1:
Table 1: Optical Density (OD) and the calculated % viability of the cells
Substance |
Optical Density (OD) |
Viability (% RV) |
|
Negative Control: |
1 |
0.680 |
102 |
PBS |
2 |
0.630 |
95 |
|
3 |
0.687 |
103 |
|
mean |
0.666 |
100 |
|
Standard deviation |
4.36 |
|
Positive Control: |
1 |
0.047 |
7.1 |
5%SDS |
2 |
0.052 |
7.8 |
|
3 |
0.038 |
5.7 |
|
mean |
0.046 |
6.9 |
|
Standard deviation |
1.07 |
|
Test Item: |
1 |
0.692 |
104 |
Sodium Isobutyrate Solution |
2 |
0.517 |
78 |
|
3 |
0.737 |
111 |
|
mean |
0.649 |
98 |
|
Standard deviation |
17.39 |
The OD value for the test item treated skin was a viability of 98%.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Following exposure to Sodium Isobutyrate Solution, the mean relative viability value of the treated skins was 98%; the test substance was not therefore irritating to skin
- Executive summary:
The reconstructed human epidermis model EPISKIN-SM is designed to predict and classify the skin irritant potential of chemicals, by measuring its cytotoxic effect, as reflected in the MTT (Thiazolyl blue) cell viability assay, on the EPISKIN reconstituted human epidermis.
Disks of EPISKIN (three units / chemical) were treated with sodium isobutyrate solution and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS. Epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan extract in acidified isopropanol was then spectrophotometrically evaluated for optical density (OD) and quantified. SDS 5% and PBS treated epidermis were used as positive and negative controls, respectively. For each treated tissue, viability was expressed as a % relative to the negative control. If the mean relative viability after 15 minutes of exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test substance is considered to be irritating to skin.
Following exposure to Sodium Isobutyrate Solution, the mean relative viability of the treated skin was 98% and therefore the substance was not considered to be irritating to skin. All validity criteria were within acceptable limits and therefore the study can be considered as valid. Based on this study, Sodium Isobutyrate Solution was not found to be irritating to the skin and does not meet the criteria for classification for skin irritation.
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