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EC number: 221-117-5 | CAS number: 3007-53-2
- 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:
- key study
- Study period:
- 2013-11-22 - 2014-05-16
- 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:
- other: MatTek Corporation; EpiOcular TM human cell construct 2010
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- N,N-dimethyldodecanamide
- EC Number:
- 221-117-5
- EC Name:
- N,N-dimethyldodecanamide
- Cas Number:
- 3007-53-2
- Molecular formula:
- C14H29NO
- IUPAC Name:
- N,N-dimethyldodecanamide
- Details on test material:
- - Name of test material (as cited in study report): N,N Dimethyldodecane-1-amide
- Test-substance No.: 13/0555-1
- Physical state: liquid
- Analytical purity: N,N-Dimethyldodecanamide: 95.9 area-%; dodecanoic acid (lauric acid): 2.26 area-%; (for details see project No. AU134560-1)
- Lot/batch No.: 0009565072
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor.
- Homogeneity: The test substance was homogeneous by visual inspection.
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro test
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): EpiOcular: Fifty microliter (50 μL) of the undiluted liquid test substance was applied covering the whole tissue surface. - Duration of treatment / exposure:
- After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.
- Observation period (in vivo):
- not applicable (in vitro test)
- Number of animals or in vitro replicates:
- not applicable (in vitro test);
- Details on study design:
- Direct MTT reduction
To assess the ability of the test material to directly reduce MTT a pretest was performed as described below. The test substance was added to 0.9 mL of the MTT solution. The mixture was incubated in the dark at about 37 °C for 55 to 65 minutes. A negative control (de-ionized water) was tested concurrently. If the MTT solution color or, in case of water-insoluble test substances the border to the water-phase, turned blue / purple, the test substance was presumed to directly reduce MTT. The direct reduction of MTT by a test substance interferes with the color density produced by metabolic capacity of the tissue and would falsify the test results. In case that direct MTT reduction occurred, two freeze-killed control tissues were treated with, each, the test article and the negative control, in the same way as described in section “Experimental procedure” (3.6), additionally.
Basic procedure
Two tissues were treated with the test substance, the PC and NC, respectively. In addition two killed tissues were used for the test substance and NC, respectively, in order to detect direct MTT reduction. There are two separate protocols for liquids and solids, differing in exposure time and postincubation period. Due to the physical condition of the test substance the protocol for liquids was applied.
Pre-incubation of the tissues
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at standard culture conditions for 16 – 24 hours (pre-incubation).
Pretreatment of the tissues
After the pre-incubation the tissues were pre-treated with 20 μL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
Application of the test substance
Using a pipette, fifty microliter (50 μL) of the undiluted liquid test substance was applied covering the whole tissue surface. Control tissues were concurrently applied with 50 μL of sterile de-ionized water (NC) or with 50 μL of methyl acetate (PC) or test substance (killed tissue control). After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.
Removal of the test substance and postincubation period
To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well prewarmed medium (post-soak immersion) in order to remove residual test substance. After 12 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 2 hours (postincubation period).
MTT incubation
After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours.
After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: mean viability of the test-substance treated tissues [%]
- Score:
- 30
- Max. score:
- 100
- Reversibility:
- other: not applicable
- Remarks on result:
- other: in vitro test EpiOcular
- Irritant / corrosive response data:
- IVIS NC: 100% viability of NC
IVIS PS: 26% viability of NC
Any other information on results incl. tables
-
Test substance
tissue 1
tissue 2
mean KC
inter-tissue
mean and variability [%]
NC
mean OD570
1.633
1.533
0.025
1.583
viability [% of NC]
103.2
96.8
-
100
6.3
13/0555-1
mean OD570
0.453
0.483
0.031
0.468
viability [% of NC]
28.6
30.5
-
30
1.9
PC
mean OD570
0.400
0.416
-
0.408
viability [% of NC]
25.3
26.3
-
26
1.0
Due to the ability of the test substance to reduce MTT directly, a KC was applied in parallel. However, the result of the KC did not indicate an increased MTT reduction (difference to KC of NC is not greater than 0.1; see section3.6.8). Thus the KC was not used for viability calculation.
Findings of the EpiOcular Test
Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Decision criteria for the combined assessment of BCOP and EpiOcular result (see also EpiOcular Test)
BCOP result | EpiOcular result | Evaluation Test Strategy |
IVIS > 55 or HIS = IV | ≤ 60% viability | ocular corrosive or severe irritant |
IVIS < 55 and HIS < IV | ≤ 60% viability | irritant |
IVIS < 55 and HIS < IV | > 60% viability | Non-irritant |
Applicant's summary and conclusion
- Interpretation of results:
- other: ocular corrosion or severe irritation in the in vitro eye irritation test strategy (combined result of BCOP and EpiOcular)
- Conclusions:
- Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria N,N Dimethyldodecane-1-amide causes ocular irritation in the in vitro eye irritation test strategy under the test conditions chosen.
- Executive summary:
EpiOcular
The potential of N,N Dimethyldodecane-1-amide to cause ocular irritation was assessed by a single topical application of 50 μL of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™).
Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The EpiOcular™ eye irritation test showed the following results:
The test substance is able to reduce MTT directly. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. The mean viability of the test-substance treated tissues was 30%. Based on the observed results it was concluded, that N,N Dimethyldodecane-1-amide shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
The result of the single EpiOcular does not exclude an severe irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed. Therefore a BCOP test was performed to receive additional information about the irritancy of the substance. Both results were used as a combined testing strategy (see endpointsummary for combined explaination).
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