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EC number: 304-990-8 | CAS number: 94313-91-4
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted guideline study to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate
- EC Number:
- 234-204-8
- EC Name:
- Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate
- Cas Number:
- 10595-49-0
- IUPAC Name:
- 3-(dodecanoylamino)-N,N,N-trimethylpropan-1-aminium methyl sulfate
- Test material form:
- liquid: viscous
- Details on test material:
- Sponsor's identification: RL 590/11
Description: pale yellow liquid
Lot number: 1023J29202
Purity: not supplied
Date received: 30 March 2012
Expiry date: 31 December 2012
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The purpose of this test is to evaluate the corrosivity potential of the test item using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model. The EPISKIN™ model is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied, and is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) test items.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: none: reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Details on study design:
- The procedure followed is based on the recommended EpiSkin™ Skin Corrosivity Test protocol INVITTOX N° 118(5) The test item is applied topically to the stratum corneum surface, at the air interface, so that undiluted and/or end use dilutions can be tested
directly. The test is based on the experience that corrosive chemicals are cytotoxic after a short term exposure to the EPISKIN™ model. Corrosive chemicals are able to penetrate the stratum corneum and are sufficiently cytotoxic to cause cell death in the underlying cell layers. Toxicity is determined by the metabolic conversion of the vital dye MTT to formazan by viable cells in the test item treated cultures relative to the negative control.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: percentage relative viability
- Run / experiment:
- 240 minutes
- Value:
- ca. 106.7
- Remarks on result:
- other: MTT reduction in the test item treated issues relative to negative control tissues
- Irritation / corrosion parameter:
- other: percentage relative viability
- Run / experiment:
- 60 minutes
- Value:
- ca. 125.5
- Remarks on result:
- other: MTT reduction in the test item treated tissues relative to negative control tissues
- Irritation / corrosion parameter:
- other: percentage relative viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 132.7
- Remarks on result:
- other: MTT reduction in the test item treated tissues relative to negative control tissues
Any other information on results incl. tables
Table 1 - Mean 0D540 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | Exposure Period | Mean OD540 of duplicate tissues | Relative mean viability (%) |
Negative Control Item | 240 minutes | 0.208 | 100* |
Positive Control Item | 240 minutes | 0.037 | 17.8 |
Test Item | 240 minutes | 0.222 | 106.7 |
60 minutes | 0.261 | 125.5 | |
3 minutes | 0.276 | 132.7 | |
* The mean viability of the negative control tissues is set at 100% |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance was non-corrosive to the skin.
- Executive summary:
The corrosivity potential of CAS# 10595 -49 -0 was evaluated using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to be compatible with OECD Guideline 431 and Method 8.40 of (EC) No. 440/2008.
At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-Ioading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density (OD) was measured at 540 nm (OD540).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results: The relative mean viability of the test item treated tissues was:
240 minutes exposure: 106.7 %
60 minutes exposure: 125.5 %
3 minutes exposure: 132.7 %
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion: The test item was considered to be Non-Corrosive to the skin.
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