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EC number: 806-688-6 | CAS number: 1180132-17-5
- 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:
- Laboratory phase of the study: 22 October 2013 to 24 October 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- no
- Remarks:
- Testing performed for worker safety evaluation rather than REACH purposes
Test material
- Reference substance name:
- 5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-amine
- EC Number:
- 806-688-6
- Cas Number:
- 1180132-17-5
- Molecular formula:
- C12H20N4
- IUPAC Name:
- 5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-amine
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: RZ2-H70762-062- Storage condition of test material: Stored at room temperature- Treatment of test material prior to testing: None- Form as applied in the test: Applied directly to the tissue surface
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- Justification for test system used The EpiDerm model incorporates several features that make it advantageous in the study of potential dermal corrosivity. The target cells are epithelial derived from human skin. The tissue posses a functional stratum corneum to model barrier properties of skin. Finally test article is are applied directly to the tissue surface, at air interface, so that undiluted and/or end use dilutions can be tested directly.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERTURE USED FOR TEST SYSTEM- Temperature used during treatment / exposure: 37oC, except tissues exposed for 3 minutes which were held at room temperature during dosing.- Temperature of post-treatment incubation: Post rinsing tissue samples are incubated at standard culture conditions (37±1ºC in a humidified atmosphere of 5±1% CO2 in air) for 180 minutes.REMOVAL OF TEST MATERIAL AND CONTROLS- Number of washing steps: One. After the appropriate exposure time, the EpiDerm™ tissues were extensively rinsed with warm (approximately 37ºC) Calcium and Magnesium-Free Dulbecco's Phosphate Buffered Saline.- Observable damage in the tissue due to washing: During the rinsing of the 60-minute tissues treated with the positive control, 8N potassium hydroxide, the first tissue detached from the tissue insert and was lost.DYE BINDING METHOD- Dye used in the dye-binding assay: MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)- Spectrophotometer: Molecular Devices' Vmax plate reader- Wavelength: 550 nmNUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:For the test material and each control two tissue samples will be used to assess viability after 3-minute exposure and two will be used to assess viability after 60 minute exposurePREDICTION MODEL / DECISION CRITERIA- Evaluation of test results:If the test material reduced tissue viability to <50% of the negative control value after a 3-minute exposure, the test material was considered corrosive. In addition, test materials which resulted in tissue viability ≥ 50% after a 3-minute exposure but <15% after a 60-minute exposure were also classified as corrosive. Test materials which resulted in tissue viability ≥ 50% after 3-minute exposure and ≥ 15% after 60-minute exposure would be classified as non-corrosive.- Criteria for Determination of a Valid Test:The assay was accepted if the positive control resulted in a corrosive classification (i.e., <50% cell viability compared to negative controls, after a 3-minute exposure and/or <15% cell viability compared to negative controls after a 60-minute exposure).
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 25 mg sample of test material was applied as dry powder directly to tissue surface followed by 25 microliters of sterile de-ionised waterNEGATIVE CONTROL- Amount(s) applied (volume or weight): 50 microliters of sterile de-ionised waterPOSITIVE CONTROL- Amount(s) applied (volume or weight): 50 microliters of 8 normal potassium hydroxide
- Duration of treatment / exposure:
- 3-minute exposure for a corrosive classification and a 60-minute confirmatory exposure for materials found to be non-corrosive by the 3-minute exposure
- Duration of post-treatment incubation (if applicable):
- Post rinsing of test article tissue samples were held at standard culture conditions for 180 minutes(37±1ºC in a humidified atmosphere of 5±1% CO2 in air)
- Number of replicates:
- Two tissues were used to assess viability after the 3-minute exposure, and two were used to assess viability after the 60-minute exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test article - 3 minute exposure time
- Value:
- ca. 98.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Non-corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test article - 60 minute exposure time
- Value:
- ca. 84.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Non-corrosive
- Other effects / acceptance of results:
- OTHER EFFECTS:- Direct-MTT reduction: The test material was not observed to directly reduce MTT in the absence of viable cells. The results of the killed control experiment (performed using 8N potassium hydroxide) showed that there was significant direct MTT reduction in the positive control-treated killed controlsDEMONSTRATION OF TECHNICAL PROFICIENCY:MatTek determines the ET-50 value following exposure to Triton X-100 (1%) for each EpiDerm™ lot. The ET-50 must fall within a range established based on a historical database of results. Histology is provided upon request.ACCEPTANCE OF RESULTS:The analysis of the data generated in this study showed that the assay was valid based on the 3-minute exposure data obtained for the positive control (corrosive prediction based on a 13.2% viability value; prediction model cut-off value is <50% viability for the 3-minute exposure time); furthermore, the corrosive prediction was also confirmed by the 60-minute exposure (single tissue) (corrosive prediction based on a 8.2% viability value; prediction model cut-off value is <15% viability for the 60 minute exposure time).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the in vitro skin corrosion assay performed, EU CLP classification criteria are not met. The test material, LSN2812839 is classified as non-corrosive as tissue viability obtained after 3 minute exposure time was 98.7% which is ≥50%60 minute exposure time was 84.7% which is ≥15%
- Executive summary:
An in vitro skin corrosion assay was performed on LSN2833975 using the EpidermTM Skin model. The method utilizes a 3-minute exposure for a corrosive classification and a 60-minute confirmatory exposure for materials found to be non-corrosive by the 3-minute exposure. Viable cells reduce the yellow, soluble, oxidized form of the MTT to the reduced blue-black insoluble form. The reduced dye is extracted from the tissue with isopropanol and the amount of reduced dye determined spectrophotometrically. The relative viability of the treated tissues is calculated as a percentage of the control viability. Test materials that reduce tissue viability to <50% within 3 minutes are classified corrosive by this method. In addition test materials which result in tissue viability of ≥50% after a 3-minute exposure, but result in tissue viability of <15% after a 60 -minute exposure are also classified as corrosive. Test materials which result in tissue viabilities of ≥50% after a 3 minute exposure, and ≥15% after a 60 -minute exposure are classified non-corrosive.
The analysis of the data generated in this study showed that the assay was valid based on the 3-minute exposure data obtained for the positive control (corrosive prediction based on a 13.2% viability value; prediction model cut-off value is <50% viability for the 3 -minute exposure time); furthermore, the corrosive prediction was also confirmed by the 60-minute exposure (single tissue) (corrosive prediction based on a 8.2% viability value; prediction model cut-off value is <15% for the 60 -minute exposure time.
The test material LSN2812839 is classified as non-corrosive as tissue viability obtained after:
3 minute exposure time was 98.7% which is≥50%
60 minute exposure time was 84.7% which is ≥15%
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