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EC number: 305-769-9 | CAS number: 95009-41-9
- 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:
- weight of evidence
- Study period:
- 13 - 14 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 26 July 2013
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES, France
Test material
- Reference substance name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- EC Number:
- 305-769-9
- EC Name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- Cas Number:
- 95009-41-9
- Molecular formula:
- not available (UVCB)
- IUPAC Name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, vegetable-oil, esters with dipropyleneglycol
- Physical state: liquid
- Analytical purity: 100% (UVCB)
- Lot/batch No.: ES 110680
- Expiration date of the lot/batch: 25 October 2016
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis
- Strain:
- other: SkinEthic, RHE/S/17 Batch No. 14 RHE 0407
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic (Batch No. 14 RHE 0407)
- Adaptions to cell culture conditions: Upon receipt, the tissues were transferred into 24-well plates containing 300 µL maintenance medium per well.
ENVIRONMENTAL CONDITIONS (Incubator)
- Temperature (°C): 37 ± 2
- CO2 gas concentration (%): 5%
- Humidity: maximum
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent negative control tissue treated with phosphate buffered saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 µL
To ensure a good contact with the epidermis, during all the treatment period, the test item was recovered with a nylon mesh provided by SkinEthic. - Duration of treatment / exposure:
- 42 min exposure
41.5 h post-incubation - Observation period:
- Not applicable
- Number of animals:
- Not applicable. Tests were performed in triplicates.
- Details on study design:
- TEST SITE
-Area of exposure: 0.5 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: After the incubation period, the inserts were washed with PBS (25 x 1 mL).
- Time after start of exposure: 42 min
CELL VIABILITY MEASUREMENTS
- Method: MTT assay
- Details on method used: For viability testing, the skin samples were placed in 300 µL MTT solution (1 mg/mL) for 3 h at 37 °C and 5% CO2. Afterwards, the precipitated blue formazan product was extracted in isopropanol for 2 h under agitation in the dark, and the concentration of formazan was measured by determining the Optical Density (OD) at 570 nm, just after dilution of the extractions in isopropanol (1:2). The absorbance was measured in triplicates of MTT extract in ELx800 absorbance microplate reader supplied by Biotek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek.
PRE-EXPERIMENTS
- To evaluate non-specific MTT-reducing capability of the test item, 16 µL of the test item were mixed with 300 µL MTT solution (1 mg/mL) similar to the procedure performed in the main test. No blue or purple colouration of the MTT solution was determined.
EVALUATION CRITERIA
The irritancy potential of the test item was evaluated based on relative mean tissue viabilities compared to the negative control tissues concurrently treated with PBS. The substance is considered to be irritant to skin if the tissue viability after 42 min of exposure and 42 h of post-incubation is less or equal to 50%. The test substance is considered as non-irritant to skin if the tissue viability after exposure and post-treatment incubation is higher than 50%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: negative control (PBS). Time point: approx. 45 h (42 min exposure followed by 41.5 h post-incubation and 3 h incubation in MTT solution). (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 84.2
- Remarks on result:
- other:
- Remarks:
- Basis: other: test material. Time point: approx. 45 h (42 min exposure followed by 41.5 h post-incubation and 3 h incubation in MTT solution). (migrated information)
- Irritation / corrosion parameter:
- other: other: (% of negative control)
- Value:
- 1.1
- Remarks on result:
- other:
- Remarks:
- Basis: other: positive control (5% SDS). Time point: approx. 45 h (42 min exposure followed by 41.5 h post-incubation and 3 h incubation in MTT solution). (migrated information)
In vivo
- Irritant / corrosive response data:
- Application of the test item on reconstructed human epidermis for 42 minutes resulted in a cell viability of 84.2% compared to the concurrent negative control tissues.
- Other effects:
- No further effects were reported.
Any other information on results incl. tables
Table 1. Summary of results
Test item |
Total OD570 of 3 replicate tissues (mean of 3 extracts from 3 tissues, triplicate measurement per extract) |
Mean relative tissue viabilitiy [%] |
SD |
Negative Control PBS |
1.156 |
100 |
1.7 |
Test Item |
0.974 |
84.2 |
14.9 |
Positive Control 5% SDS |
0.013 |
1.1 |
0.0 |
OD: Absorption at 570 nm
SD: Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this in vitro study, the test item showed no irritant effects. The test item is therefore classified as not irritating.
CLP: non classified
DSD: non classified
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