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EC number: 216-014-7 | CAS number: 1474-02-8
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005-05-20 to 2005-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study (OECD-430) with detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
- EC Number:
- 216-014-7
- EC Name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
- Cas Number:
- 1474-02-8
- Molecular formula:
- C21H26N2O
- IUPAC Name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropanamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-1594164-AAA (T000424)
- Physical state: solid (powder)
- Appearance: White powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RT000424G1A251
- Expiration date of the lot/batch: 2005-12-31
- Purity test date: no data
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: the solid test item was ground to produce a granular material immediately prior to testing.
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Source strain:
- Wistar
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Sex:
- Age at study initiation (in days): 29 days
- Weight at study initiation:
- Housing: Single, in Makrolon type II cages, with wire mesh top (EHRET GmbH, D-79302 Emmendingen), granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
- Water (e.g. ad libitum): tap water, ad libitum (Gemeindewerke, D-64380 Rossdorf)
- Acclimation period: minimum 10 days. During this period the animals did not show signs of illness or altered behaviour.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 21+/- 3°C
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light (artifical light 6.00 a.m. - 6.00 p.m.)
IN-LIFE DATES: From: no data To: no data - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- The dorsal flank hair was carefully removed. The animals were then washed by careful wiping, whilst submerging the area in antibiotic solution containing streptomycin and penicillin to inhibit bacterial growth. Animals were washed with antibiotics again three days after the first wash, and were used within 3 days.
- Procedure used: animals were anaesthetised with CO2 and subsequently decapitated. The dorsal skin of each animal was removed and stripped of excess fat by carefully peeling it away from the skin. The skin was placed over the end of a PTFE (polytetrafluoroethylene) tube, ensuring that the epidermal surface was in contact with the tube. A rubber 'O' ring was press-fitted over the end of the tube to hold the skin in place and excess tissue was trimmed away. The tube was supported by a spring clip inside a receptor chamber containing magnesium sulphate solution (154 mM).
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was [complete, e.g. 10 kΩ]
TEMPERATURE USED FOR TEST SYSTEM
- no data
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: test item was removed by washing with a jet of tap water at up to 30°C until no further material could be removed.
DYE BINDING METHOD
- Dye used in the dye-binding assay: Sulforhodamine B
- Spectrophotometer: no data
- Wavelength: 565 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the mean TER value is less than or equal to 5 kΩ, if verified by the dye binding assay.
- The test substance is considered to be non-corrosive to skin if the mean TER value obtained for the test item is greater than 5 kΩ.
- If the mean TER value obtained was greater than or equal to 5 kOhms than the corrosivity was required to be confirmed by the dye binding assay. If the dye binding content is greater than or equal to the the mean disc content of the positive control, then the test substance is truely corrosive. If the mean disc dye content is well below the mean disc content of the positive control , then the test substance is a false positve and therefore, non-corrosive. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0594 g, 0.0681 g, 0.0552 g of the test item was applied per skin disc. 150 uL deionised water was added on top of the test substance and was evenly distributed by shaking of the tube.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 150 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 150 µL
- Concentration (if solution): 36% (~10 M) - Duration of treatment / exposure:
- 24 h
- Number of replicates:
- 3 replicates per test group (test item, negative control and positive control)
Test system
- Duration of treatment / exposure:
- 24
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Remarks:
- mean of 3
- Run / experiment:
- 1
- Value:
- 2.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- SD = 0.75
- Other effects / acceptance of results:
- Resistance (kOhm):
- Negative control (mean of 3 replicates): 11.0 +/- 0.21
- Positive control (mean of 3 replicates): 0.6 +/- 0.03
Impedance measurements of all three skin discs treated with the test item indicated a corrosive effect induced by the test substance. Nevertheless, the sulforhodamine content was well below the dye content of the positive control and only slightly above the negative control. Furthermore, the skin discs appeared macroscopically intact after treatment.
Any other information on results incl. tables
Table 1. Summary of the TER-results
Sample | Resistance (kOhm) | Mean | Standard deviation | Corrosive |
Negative Control 1 | 12.8 | |||
Negative Control 2 | 9.9 | 11.0 | 0.21 | No |
Negative Control 3 | 10.2 | |||
Positive Control 1 |
0.6 | |||
Positive Control 2 | 0.5 | 0.6 | 0.03 | Yes |
Positive Control 3 | 0.6 | |||
T424 1 | 2.4 | |||
T424 2 | 2.5 | 2.9 | 0.75 | Yes |
T424 3 | 3.8 |
11.0 and 0.21 are the mean and the standard deviation values, respectively, of the three negative controls.
0.6 and 0.03 are the mean and the standard deviation values, respectively, of the three positive controls.
2.9 and 0.75 are the mean and the standard deviation values, respectively, of the test substance tested in three skin disc replicates.
Table 2. Summary of the Sulforhodamine B-results
Sample | Absorption 565 nm | Sulforhodamine B content (ug/disc) | Mean | Standard Deviation | Corrosive | |
Negative Control 1 | 0.06 | 10.6 | ||||
Negative Control 2 | 0.069 | 12.6 | 17.0 | 9.39 | No | |
Negative Control 3 | 0.138 | 27.8 | ||||
Positive Control 1 |
0.490 | 105.2 | ||||
Positive Control 2 | 0.747 | 161.8 | 131.8 | 28.44 | Yes | |
Positive Control 3 | 0.595 | 128.3 | ||||
T424 1 | 0.152 | 30.9 | ||||
T424 2 | 0.202 | 41.9 | 32.8 | 8.31 | No | |
T424 3 | 0.128 | 25.6 |
17.0 and 9.39 are the mean and the standard deviation values, respectively, of the three negative controls.
131.8 and 28.44 are the mean and the standard deviation values, respectively, of the three positive controls.
32.8 and 8.31 are the mean and the standard deviation values, respectively, of the test substance tested in three skin disc replicates.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- T424 is considered to be non-corrosive in the TER test.
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