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EC number: 216-543-3 | CAS number: 1609-66-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2006-05-10 to 2006-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD guideline 404 (Acute Dermal Irritation/Corrosion) and EU method B.4. (Acute Toxicity: Dermal Irritation/Corrosion) with one deviation: the test substance was put on a surgical gauze patch of approximately 4 cm x 4 cm instead of 6 cm2 to guarantee a good contact and uniform distribution of the test substance on the skin. This deviation should not affect the reliability of this study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The test substance was put on a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The test substance was put on a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2).
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from the Swiss GLP Monitoring Authorities
Test material
- Reference substance name:
- N-phenyl-N-piperidin-4-ylpropionamide
- EC Number:
- 216-543-3
- EC Name:
- N-phenyl-N-piperidin-4-ylpropionamide
- Cas Number:
- 1609-66-1
- Molecular formula:
- C14H20N2O
- IUPAC Name:
- N-phenyl-N-piperidin-4-ylpropionamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-1594255-AAA (T000425)
- Physical state: solid (powder)
- Appearance: white
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutica N.V., 00454795
- Expiration date of the lot/batch: 31 December 2005
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: stability not indicated by the Sponsor; solubility in water: 43 g/L and solubility in ethanol > 500 g/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The solid test item was ground to produce a granular material immediately prior to testing
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan France, Zl Le Malcourlet, 03800 Gannat, France
- Age at study initiation: 15 weeks (males and females)
- Weight at study initiation: 2091 to 2362 grams for females, 2293 grams for male
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Fűllinsdorf, ad libitum
- Acclimation period: 2006-05-10 to 2006-05-14 (one female); 2006-05-10 to 2006-05-15 (one male and one female)
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23 deg C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other:
- Controls:
- other: Untreated skin area was used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reaction was assessed at approximately 1, 24, 48, and 72 hours after exposure (removal of the dressing, gauze patch and test substance).
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: left flank (approximately 100 cm2) was clippped. The gauze patch (4 cm x 4 cm) with the test substance was applied to the intact skin of the clipped area.
- % coverage: no data
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours after the start of exposure
SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean score across 3 scoring times (24, 48 and 72 hour)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean score across 3 scoring times (24, 48 and 72 hour)
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean score across 3 scoring times (24, 48 and 72 hour)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of the 3 animals
- Time point:
- other: mean score across 3 scoring times (24, 48 and 72 hour)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.33, 0.67 and 0.33, respectively and the mean oedema score was 0.00 for all animals.
All three animals showed a very slight to well-defined erythema at the 1-hour reading, which persisted as very slight until 24 hours after application in two animals, and until 48 hours after application in one animal.
No abnormal findings were observed on the treated skin of any animal 72 hours after treatment, the end of the observation time.
Neither alterations of the treated skin were observed, nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. No staining produced by the test substance of the treated skin was observed. The body weights of all animals were considered to be within the normal range of variability.
Any other information on results incl. tables
Coloration:
No staining produced by the test item of the treated skin was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be "not irritating" to rabbit skin under the conditions of this study.
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