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EC number: 269-665-4 | CAS number: 68308-74-7
- 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:
- 21-18 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- adopted 22 July 2010
- 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:
- Amides, tall-oil fatty, N,N-di-Me
- EC Number:
- 269-665-4
- EC Name:
- Amides, tall-oil fatty, N,N-di-Me
- Cas Number:
- 68308-74-7
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Amides, tall-oil fatty, N,N-di-Me
- Reference substance name:
- DMATO
- IUPAC Name:
- DMATO
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): DMATO
- Physical state: clear, brown liquid
- Analytical purity: 100%
- Lot/batch No.: 12J46399
- Expiration date of the lot/batch: October 2015
- Storage condition of test material: At room temperature (20±5°C) in the dark
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Buckman Laboratories, Lot No. 12J46399
- Expiration date of the lot/batch: 01/10/2015
- Purity test date: 100%; certificate of analysis dated 05/11/2012
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: assumed stable for study duration
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: adult-human derived epidermal keratinocytes
- Details on animal used as source of test system:
- Not applicable - in vitro study
- Justification for test system used:
- RhE model specified in the OECD Guideline
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN RHE Model (skinEthic Laboratories, Lyon, France)
- Delivery date: 12/02/2013
- Date of initiation of testing: 12/02/2013
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of exposure each tissue was removed from the well using forceps and rinsed using a wash bottle containing Dulbecco's phosphate buffered saline (DPBS). Rinsing was achieved by filling and emptying each tissue inert for approx. 40 seconds using a constant soft stream of DPBS to gently remove residual test material.
- Observable damage in the tissue due to washing: None.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 540 nm
- Filter: none
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: water-killed tissues
- Procedure used to prepare the killed tissues (if applicable): untreated EPISKIN tissues were placed in a 12-well plate containing 2.2 mL of sterile distilled water, then incubated at 37°C, 5% CO2 in air for 48±1 hours.
- Result : Negligible intereference due to reduction of MTT by the test material occurred therefore the results were not used for quantitative correction of results
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritating to skin if the viability after 15 minutes exposure is less than or equal to 50%.
- The test substance is considered to be non-irritating to skin if the viability after 15 minutes exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- The test material was used as supplied, 10 µL was applied to the surface of the epidermis.
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Tissues treated in triplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 114.4
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The relative mean viability of the treated tissues was 114.4% after a 15 minute exposure period. The relative mean tissue viability for the positive control was 10.2% relative to the negative control and the standard deviation was 2.3%. The mean OD540 for the negative control was 0.834 and the standard deviation of the percent viability was 10.8%. The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 8.5%. The acceptance criteria were therefore met for this assay.
Any other information on results incl. tables
An assessment found the test material was able to directly reduce MTT. An additional procedure using water-killed tissues was performed during the determination of skin corrosivity potential. The results obtained showed negligible interference due to direct MTT reduction. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results or for reporting purposes.
Table 1. Mean OD540 values and percentage viabilities
Item |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control |
0.752 |
0.834 |
0.090 |
90.2 |
100* |
10.8 |
0.819 |
98.2 |
|||||
0.930 |
111.5 |
|||||
Positive Control |
0.106 |
0.085 |
0.019 |
12.7 |
10.2 |
2.3 |
0.080 |
9.6 |
|||||
0.068 |
8.2 |
|||||
Test material |
0.912 |
0.954 |
0.071 |
109.4 |
114.4 |
8.5 |
0.913 |
109.5 |
|||||
1.036 |
124.2 |
SD = standard deviation; * = mean viability of the negative control is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: non irritating
- Conclusions:
- The test material was considered to be non-irritating as the relative mean tissue viability was > 50% (114.4%).
- Executive summary:
The skin irritating potential of DMATO was evaluated in the EPISKIN reconstructed human epidermis model, according to OECD Guideline 439 and GLP. Cell viability following exposure is measured by enzymatic reduction of the yellow MTT tetrazolium salt to a blue formazan salt (within the mitochondria of viable cells) in treated tissues compared to relative controls.
10 µL of the test material was applied undiluted to the tissues for a 15 minute exposure period, followed by a 42 hour post-exposure incubation period. The test material, positive and negative controls were tested in triplicate. At the end of the post-exposure incubation period each tissue was taken for MTT loading. After MTT loading a total biopsy of each epidermis was made and placed into tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT loaded tissues. At the end of the formazan extraction period each tubed was mixed and duplicate 200 µL samples were transferred to a 96 -well plate. The optical density was measured at 540 nm. The percentage viability is calculated from the MTT reduction in treated tissues relative to the negative control.
The relative mean viability of the treated tissues was 114.4%. The relative mean tissue viability was greater than 50%, therefore the test material is considered to be non-irritating under the conditions of the study.
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