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EC number: 219-145-8 | CAS number: 2372-82-9
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 2, 2010 to March 5, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- EC Number:
- 219-145-8
- EC Name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Cas Number:
- 2372-82-9
- Molecular formula:
- C18H41N3
- IUPAC Name:
- bis(3-aminopropyl)(dodecyl)amine
- Test material form:
- liquid
- Details on test material:
- Description: Hazy colourless liquid
Batch: S-001148
Purity: 90.9%
Test substance storage: At room temperature in the dark under nitrogen
Stability under storage conditions: Stable
Expiry date: 04 February 2018
Study specific test substance information:
Test substance handling: When the appearance is becoming cloudy, it might have been cooled for some time. In that case it is best to warm the sample (under nitrogen or in closed bottle) up to about 50 °C, until it is clear again. Draw a sample form the clear solution.
Stability at higher temperatures: Yes, maximum temperature 250°C
Constituent 1
- Specific details on test material used for the study:
- Identification: Dodecyldipropylenetriamine
Chemical name: N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
Molecular formula: C18H41N3
Molecular weight: 299.54
Description: Hazy colourless liquid (determined at NOTOX)
Batch: S-001148
Purity: 90.9%
Test substance storage: At room temperature in the dark under nitrogen
Stability under storage conditions: Stable
Expiry date: 04 February 2018
Study specific test substance information:
Test substance handling: When the appearance is becoming cloudy, it might have been cooled for some time. In that case it is best to warm the sample (under nitrogen or in closed bottle) up to about 50 °C, until it is clear again. Draw a sample form the clear solution.
Stability at higher temperatures: Yes, maximum temperature 250°C
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC)
- Vehicle:
- water
- Details on test system:
- Test system
EpiDerm Skin Model (EPI-200, Lot no.: 12935 kit H): The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Source:
MatTek Corporation, Ashland MA, U.S.A. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Undiluted (50 μl) directly on top of the tissue
- Duration of treatment / exposure:
- 3 minutes and 1 h
- Number of replicates:
- 2 for a 3 minute and 1 h exposure to test substance
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 43
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure
- Value:
- 42
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test substance was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because a colour change was observed it was concluded that test substance did interact with MTT. In addition to the normal 1-hour procedure, one freeze-killed tissue treated with test substance and one freeze-killed non treated tissue was used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by test substance was 4.72% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. The mean absorption at 540 nm measured after treatment with test substance and controls are presented in Table 1. The individual OD540 measurements are presented in Appendix I. Table 2 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with test substance compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with test substance compared to the negative control tissues was 43% and 42% respectively.
Table 1: Mean absorption in the in vitro skin corrosion test with test substance
3 minute application
|
1 hour application
|
|||||||
A (OD540) |
B (OD540) |
Mean (OD540) |
SD |
A (OD540) |
B (OD540) |
Mean (OD540) |
SD |
|
Negative control |
1.683 |
1.699 |
1.691 |
±0.011 |
1.707 |
1.710 |
1.708 |
±0.002 |
Dodecyldipropyl enetriamine |
0.702 |
0.736 |
0.719 |
±0.025 |
0.721 |
0.716 |
0.719 |
±0.004 |
Positive control |
0.150 |
0.143 |
0.147 |
±0.005 |
0.148 |
0.145 |
0.147 |
±0.002 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
(1) The values are corrected for the non-specific MTT reaction.
In this table the values are corrected for background absorption. Isopropanol was used to measure the background absorption
Table 2: Mean tissue viability in the in vitro skin corrosion test with Dodecyldipropylenetriamine
3 minute application viability (% of control) |
1 h application viability (% of control) |
|
Negative control |
100 |
100 |
Dodecyldipropyl enetriamine |
43 |
42 |
Positive control |
9 |
9 |
APPENDIX I: Individual OD measurements at 540 NM
3 minute application (OD540) |
1 hour application (OD540) |
1 hour application freeze killed (OD540) |
||||
A |
B |
A |
B |
treated |
non-treated |
|
Negative control |
||||||
(OD540) measurement 1 |
1.686 |
1.686 |
1.704 |
1.713 |
||
(OD540) measurement 2 |
1.694 |
1.703 |
1.709 |
1.714 |
||
(OD540) measurement 3 |
1.670 |
1.709 |
1.708 |
1.702 |
||
Dodecyldipropyl enetriamine |
||||||
(OD540) measurement 1 |
0.789 |
0.815 |
0.820 |
0.796 |
0.453 |
0.373 |
(OD540) measurement 2 |
0.779 |
0.815 |
0.794 |
0.798 |
0.446 |
0.368 |
(OD540) measurement 3 |
0.779 |
0.815 |
0.792 |
0.797 |
0.444 |
0.360 |
Positive control |
||||||
(OD540) measurement 1 |
0.155 |
0.144 |
0.149 |
0.146 |
||
(OD540) measurement 2 |
0.149 |
0.143 |
0.148 |
0.144 |
||
(OD540) measurement 3 |
0.146 |
0.142 |
0.147 |
0.145 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was identified as corrosive to skin.
- Executive summary:
A study was conducted to determine the skin corrosive property of the test substance (90.9% purity)in vitroaccording to OECD Guideline 431, in compliance with GLP. The test substance was applied undiluted (50 μL) directly on top of the skin tissue. Test substance did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal 1 h procedure, one freeze-killed tissue treated with test substance and one freeze-killed non treated tissue was used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by test substance was 4.72% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 min and 1 h treatments with test substance compared to the negative control tissues was 43 and 42%, respectively. Because the mean relative tissue viability for test substance was below 50% after the 3 min treatment, it was considered to be corrosive. Under the study conditions, the test substance was identified as corrosive to skin (Buskens, 2010).
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