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Diss Factsheets
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EC number: 942-655-3 | CAS number: 1802727-84-9
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-02-22 to 2016-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation (EC) No 440/2008, Annex Part B, B.40Bis: “In Vitro Skin Corrosion: Human Skin Model Test”, Official Journal of the European Union No. L142, dated May 31st, 2008.
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX Protocol No. 118; “EPISKINTM Skin Corrosivity Test” updated December 2011 / February 2012 (ECVAM Database Service on Alternative Methods to Animal Experimentation).
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N1-benzylpropane-1,2-diamine
- Cas Number:
- 55115-91-8
- Molecular formula:
- C10H16N2
- IUPAC Name:
- N1-benzylpropane-1,2-diamine
- Reference substance name:
- N2-Benzylpropane-1,2-diamine
- Cas Number:
- 3535-17-9
- Molecular formula:
- C10H16N2
- IUPAC Name:
- N2-Benzylpropane-1,2-diamine
- Test material form:
- liquid
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Source species:
- other: reconstructed human epidermis
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EPISKIN model has been validated for corrosivity testing in an international trial; it is considered to be suitable for this study (STATEMENT ON THE SCIENTIFIC VALIDITY OF THE EPISKINTM TEST (AN IN VITRO TEST FOR SKIN CORROSIVITY); ECVAM JRC Environment Institute, European Commission; Ispra; 03 April 1998).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTMSM, EPISKIN SNC Lyon, France
- Supplier: SKINETHIC Laboratories; 4, rue Alexander Fleming, 69007 – LYON, France
- Tissue batch number: first experiment: 16-EKIN-013; second experiment: 16-EKIN-018
- Expiry date: 04 April 2016 / 09 May 2016
- Date of initiating testing: 31 March 2016 / 4 May 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After the incubation time, the units were removed and rinsed thoroughly with approximately 25 mL PBS 1 x solution to remove all of the test material from the epidermal surface. The rest of the PBS was removed from the epidermal surface with a suitable pipette tip linked to a vacuum source (care was taken to avoid damaging to the epidermis).
- Observable damage in the tissue due to washing: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL of 0.3 mg/mL MTT
- Incubation time: 3 h
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues: Water- killed epidermis preparation: Place the living epidermis in a 12 well plate with 2 mL of distilled water (replacing the culture medium). Incubate at 37 °C, 5% CO2, ≥95% humidified atmosphere for 48 hrs +/- 1 hour. At the end of the incubation, discard the water. Keep dead epidermis frozen (dry) in freezer at -18°C to -20°C (killed epidermis can be stored and used up to 6 months). Before use, the killed tissues are de-frozen at room temperature (app. 1 hour in 2 mL of maintenance medium). Further use of killed tissues is similar to living tissues.
- N. of replicates: 2
- Method of calculation used: Non specific MTT reduction calculation (NSMTT), according to guidelines.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA:
- The test substance is considered to be corrosive to skin (Cat. 1A) if the viability after 3 minutes exposure is less than 35%.
- The test substance is considered to be corrosive to skin (Cat 1B and 1C) if the viability after 3 minutes exposure is greater than or equal to 35% AND after 60 minutes exposure smaller than 35%; or if the viability after 60 minutes exposure is greater than or equal to 35% AND after 240 minutes exposure smaller than 35%.
- The test substance is considered to be non-corrosive to skin if the viability after 4 hours exposure is greater than or equal to 35%.
- Justification for the selection of the cut-off point: The cut-off value of 35 % and classification method was validated in an international validation of this kit (Fentem, 1998). The prediction model corresponds to the methods agreed by EU regulatory agencies in line with OECD 431 (OECD, 2015). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
NEGATIVE CONTROL
- Amount applied: 50 µL
- Concentration: 9 g/L
POSITIVE CONTROL
- Amount applied: 50 µL - Duration of treatment / exposure:
- first experiment: 4 hours
second experiment: 4 hours, 1 hour, 3 minutes - Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 (exposure: 4 h)
- Value:
- 5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2 (exposure: 4 h)
- Value:
- 5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2 (exposure: 1 h)
- Value:
- 37
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2 (exposure: 3 min)
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes. During the check-method for possible direct MTT reduction, colour change was observed after three hours of incubation. The test item interacted with the MTT, therefore additional controls and data calculations were necessary. The non-specific MTT reduction (NSMTT) was determined to be 11.344 %. in first experiment and was determined to be 22.499 % at 4 hours exposure, 45.701 % at 1 hour exposure and 6.422 % at 3 minutes exposure in the additional experiment. As the NSMTT were below 50 % the true MTT metabolic conversion in all occasions and the correction of viability percentages were undertaken.
- Colour interference with MTT: no. The test item showed no ability to become coloured in contact with water therefore additional controls and data calculations were not necessary. A false estimation of viability can be excluded.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD value of the two negative control tissues was in the first experiment: 0.891 and in the second experiment: 1.455 at 4 hours exposure, 1.406 at 1 hour exposure and 1.446 at 3 minutes exposure.
- Acceptance criteria met for positive control: The positive control result showed in the first experiment 0 % viability, in the second experiment 2 % viability.
- Acceptance criteria met for variability between replicate measurements: first experiment: The difference of viability between the two tissue replicates: 0% to 4%; second experiment: The difference of viability between the two tissue replicates: 0% to 14%.
Applicant's summary and conclusion
- Conclusions:
- In this in vitro skin corrosion test using the EPISKIN model with the test item the results indicate that the test item is corrosive to skin after 4 hours exposure and not corrosive after 1 hour and 3 min exposure. According to the UN GHS classification systems, the test item has been categorized as “Corrosive: Optional Sub- categories 1B and 1C”.
- Executive summary:
The purpose of this study was to determine the skin corrosion potential of the test item on reconstituted human epidermis in the EPISKIN model in vitro. According to the results of the first experiment the test item was corrosive after 4 hours exposition, so the additional experiment was necessary with more exposure times (testing at 3 minutes and 1 hour). In this case, the 4 hour procedure was repeated during the additional experiment, but with an additional 3 minute and 1 hour exposure period. Disks of EPISKIN (two units) were treated with test item and incubated for 4 hours at room temperature on March 31, 2016 (first experiment). Furthermore, disks of EPISKIN (two units / exposure time) were treated with test item and incubated for 4 hours, 1 hour and 3 min at room temperature on May 04, 2016 (additional experiment). Exposure of test material was terminated by rinsing with PBS 1x solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. The test item is a possible MTT-reducer, therefore additional controls (test item treated killed tissues and negative control treated killed tissues) were used to detect and correct for test substance interference with the viability measurement. NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue, viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control. The test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours of exposure in both experiments. In the first experiment (March 31, 2016) the average test item treated tissue viability (corrected value) was 5% and in the additional experiment (May 04, 2016) it was 5% at 4 hours of exposure. In the additional experiment the test item treated tissue viabilities (corrected value) were above 35 % of the mean negative control value after 1 hour and 3 min of exposure. The average test item treated tissue viabilities (corrected value) were 37 % at 1 hour and 96 % at 3 minutes of exposure. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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