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EC number: 214-583-6 | CAS number: 1155-56-2
- 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:
- 2006-07-10 to 2006-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 404 "Acute Dermal Irritation/Corrosion" and Commission Directive 2004/73/EC, 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from the Swiss GLP Monitoring Authority
Test material
- Reference substance name:
- 1-benzyl-N-phenylpiperidin-4-amine
- EC Number:
- 214-583-6
- EC Name:
- 1-benzyl-N-phenylpiperidin-4-amine
- Cas Number:
- 1155-56-2
- Molecular formula:
- C18H22N2
- IUPAC Name:
- 1-benzyl-N-phenylpiperidin-4-amine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-1594008-AAA (T000293)
- 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: 00479757RT000293G1A401
- Expiration date of the lot/batch: 2011-01-15
- Purity: 100%
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 +/- 5°C), light protected
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was weighed as delivered by the sponsor and then moistened with approximately 0.5 mL of purified water.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: young adult New Zealand White rabbits, SPF; Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands
- Age at study initiation: 13 weeks (1 male) and 13-14 weeks (2 females)
- Weight at study initiation: 2763 g (male), 2639 - 2780 g (females)
- Housing: Standard Laboratory Conditions; individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: community tap water from Füllinsdorf, ad libitum
- Acclimation period: from 2006-07-05 to 2006-07-09, under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.
IN-LIFE DATES: From: 2006-07-10 To: 2006-07-17
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas were used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (per animal) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days (observations made at 1, 24, 48 and 72 hours, as well as 7 days after exposure)
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: The left flank was clipped with an electric clipper, exposing an area of approximately 100 cm² (10 cm x 10 cm). The test substance was applied under a 4 cm x 4 cm surgical gauze patch. The gauze patch 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.
- Other:
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at the time.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- The skin reaction was assessed at approximately 1, 24, 48 and 72 hours as well as 7 days after exposure (removal of the dressing, gauze patch and test item).
SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, (see scoring table in "Any other information on materials and methods" section below).
- If evident, corrosive or staining properties of the test substance were described and recorded.
- 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. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: male
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: female
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: female
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Irritation:
- The mean erythema/eschar score of the three animals was 0.00, 0.00 and 1.00, respectively and the mean oedema score was 0.00. The application of the test item to the skin resulted in very slight erythema in one animal from the 1- to the 72-hour reading.
Corrosion:
- Neither alterations of the treated skin were observed, nor were corrosive effects evident on the skin. - Other effects:
- Viability/Mortality/Clinical signs
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Coloration:
- No staining produced by the test item of the treated skin was observed.
Body Weights:
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), T000293 is considered to be "not irritating" to rabbit skin.
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