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EC number: 260-257-1 | CAS number: 56554-53-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Principles of method if other than guideline:
- In vitro eye irritation test using the SkinEthic reconstructed Human Corneal Epithelium (HCE) model
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
Test material
- Reference substance name:
- Propane-1,2,3-triyl 3,5,5-trimethylhexanoate
- EC Number:
- 260-257-1
- EC Name:
- Propane-1,2,3-triyl 3,5,5-trimethylhexanoate
- Cas Number:
- 56554-53-1
- Molecular formula:
- C30H56O6
- IUPAC Name:
- 1,3-bis[(3,5,5-trimethylhexanoyl)oxy]propan-2-yl 3,5,5-trimethylhexanoate
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- TEST TISSUE
- Test model: SkinEthic reconstructed Human Corneal Epithetial model (SkinEthic HCE)
- Source: HCE, SkinEthic Laboratories, Nice, France
- Description: Transformed human corneal epithelial cells of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye. The test item is applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. The model consists of an airlifted, living, corneal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium.
- Age of tissue at study initiation: 6 days
- Tissue storage/maintenance: Upon arrival, tissues were stored at room temperature prior to transferring into 24-well plates designated “arrival plates” containing 300 µl of maintenance medium. It was ensured that there were no air bubbles present under the tissue inserts.
INCUBATION CONDITIONS
- Temperature (°C): 37
- CO2 (%): 5
PREPARATION OF TISSUE
Prior to treatment, 7-day old tissues were transferred from the “arrival plates” to 6-well plates designated “treatment plates” (for test item, negative and positive controls) containing 1 mL maintenance medium at room temperature.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, negative control solution (Solution A)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 30 µL
NEGATIVE CONTROL
- Identity: Solution A (0.142 g/L Na2HPO4; 1.802 g/L Glucose; 7.149 g/L HEPES; 0.224 g/L KCl; 7.597 g/L NaCl)
- Concentration: as such
- Amount(s) applied in the test: 30 µL
POSITIVE CONTROL SUBSTANCE
- Identity: Sodium Dodecyl Sulphate (SDS)
- Concentration: 2% (w/v)
- Amount(s) applied in the test: 30 µL - Duration of treatment / exposure:
- 10 min at 37°C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 tissues
- Details on study design:
- PRE-TEST
ASSESSMENT OF DIRECT TEST ITEM REDUCTION OF MTT
The MTT Assay, a colourimetric method of determining cell viability, is based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan dye by mitochondrial succinate dehydrogenase in viable cells.
The possible interference of the test item with the MTT assay by its potential ability to directly reduce MTT was tested prior to the main test. 30 µL of the test item was added to 1 mL of a 0.5 mg/mL MTT solution and incubated at 37 °C, 5% CO2 in air for 3 h. Untreated MTT solution was used as a control. If the MTT solution turned blue, the test item was presumed to have reduced MTT.
MAIN TEST
POST-EXPOSURE TREATMENT
- Removal of the test item: At the end of the exposure period, tissue inserts were removed from the wells and rinsed with Dulbecco’s Phosphate Buffered Saline without Ca++ and Mg++.
- Post-exposure incubation conditions: Tissues were placed into 24-well plates designated “holding plates” containing 300 µL of maintenance medium (at room temperature) until all tissues had been rinsed.
MTT ASSAY
- Loading: Following rinsing, tissues were transferred to 24-well plates (“MTT Loading plates”), each well containing 300 µL of a 0.5 mg/mL MTT solution freshly prepared in maintenance medium.
- Incubation conditions: 3 h at 37 °C, 5% CO2 in air
- Extraction: At the end of the incubation period, tissues were rinsed twice with phosphate buffered saline, blotted on absorbent paper to remove residual MTT and transferred to 24-well plates (“MTT extraction plates”) containing 750 µL isopropanol per well. Further 750 µL isopropanol were added to each well and plates were sealed to prevent evaporation.
- Extraction conditions: formazan crystals were extracted from the tissues overnight at room temperature protected from light.
- Optical density measurement: At the end of the extraction period, triplicate 200 µL aliquots of the extraction solutions were transferred to a 96-well plate. The optical density was measured at 540 nm (OD540) using the Anthos 2001 microplate reader for determination of tissue viability. Isopropanol served as blank.
TISSUE HISTOLOGY
One tissue per treatment group (test item, negative and positive controls) was retained for possible tissue histopathology.
The tissues were carefully cut out of the polycarbonate inserts with a sharp scalpel. The tissues were carefully cut in half. Both halves were placed into a 1.5 mL Eppendorf tube containing 1 mL of 10% formalin and stored at room temperature.
INTERPRETATION OF RESULTS
- Tissue viability: The mean OD540 values of the duplicate tissues were calculated. Each of these values had already been corrected for blanks by the microplate reader. The relative mean tissue viability (percentage of the negative control) was calculated as follows:
Relative mean tissue viability (%) = [(mean OD540 of test item)/(mean OD540 of negative control)] x 100
SCORING SYSTEM
The mean tissue viability for the test item was compared to the negative control and classified according to the following criteria:
Irritant (I): If the relative mean tissue viability (percentage of negative control) was < 60.
Non-Irritant (NI): If the relative mean tissue viability (percentage of negative control) was ≥ 60.
ASSAY ACCEPTANCE CRITERION
The results of the assay were considered acceptable if the following assay acceptance criterion was achieved:
- Assay acceptance criterion: Positive control
The assay meets the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is < 60% relative to the negative control treated tissues.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Relative Mean Viability (%)
- Value:
- 92.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The individual and mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test item treated tissues after a 10 min exposure period was 92.6%
It was considered unnecessary to proceed with tissue histopathology.
The MTT solution containing the test item remained yellow which indicated that the test item did not directly reduce MTT.
Table 1. Assessment of eye irritation potential – Viability of HCE tissues
Item |
OD540 of individual tissue |
Mean OD540 |
Relative Mean Viability (%) |
Negative control |
0.812 |
0.838 |
100* |
0.863 |
|||
Positive control |
0.152 |
0.111 |
13.2 |
0.069 |
|||
Test item |
0.779 |
0.776 |
92.6 |
0,773 |
* The mean viability of the negative control tissues was set at 100%
Assay Acceptance Criterion
The relative mean viability of the positive control treated tissues after a 10 min exposure period was 13.2%. Thus, the quality criterion required for the acceptance of results in the test was satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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