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EC number: 254-479-8 | CAS number: 39512-49-7
- 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:
- key study
- Study period:
- 2006-05-10 to 2006-06-01
- 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) without deviations that would impact the results.
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
- Remarks:
- : The testing facility reported the following deviations from the protocol: 1) the test substance was put on a surgical gauze patch of approx. 4 cm x 4 cm (instead of 6 cm2); 2) the pH of the test substance was measured before the study initiation date.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- : The testing facility reported the following deviations from the protocol: 1) the test substance was put on a surgical gauze patch of approx. 4 cm x 4 cm (instead of 6 cm2); 2) the pH of the test substance was measured before the study initiation date.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- : Certificate from the Swiss GLP Monitoring Authorities
Test material
- Reference substance name:
- 4-(p-chlorophenyl)piperidin-4-ol
- EC Number:
- 254-479-8
- EC Name:
- 4-(p-chlorophenyl)piperidin-4-ol
- Cas Number:
- 39512-49-7
- Molecular formula:
- C11H14ClNO
- IUPAC Name:
- 4-(p-chlorophenyl)piperidin-4-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-117676-AAA (T000263)
- Physical state: solid (powder)
- Appearance: White, slight beige amorphous, crystalline, micropowder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 8693
- Expiration date of the lot/batch: 2007-12-31
- 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: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was moistened with approximately 0.5 mL of purified water before application
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan France (ZI Le Malcourlet, 03800 Gannat, France)
- Age at study initiation: 12 weeks (male), 13-15 weeks (females)
- Weight at study initiation: male 2297 grams; female 2402 g; female 2280 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 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 Füllinsdorf, ad libitum
- Acclimation period: 4 days (one female); 7 days (one male and one female), under laboratory conditions after health examination. Only animals without any visual signs of illness were used.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approximately 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music was played during the daytime light period
IN-LIFE DATES: From: 2006-05-10 To: 2006-06-01
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams per animal was delivered and then moistened with approximately 0.5 mL purified water before application
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hrs; 7, 10 and 14 days after exposure (removal of the dressing, gauze patch and test item)
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm
- % coverage: no data
- Type of wrap if used: surgical gauze, covered with semi-occlusive dressing and anchored with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tapwater
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
- 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: animal #91 mean score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal: animal #92 mean score
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal: animal #93 mean score
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: #91 mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: animal #92 mean score
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: animal #93 mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- The test substance was found to be irritating based on erythema. The test substance was found to be not irritating based on edema.
- Other effects:
- No clinical signs of systemic toxicity were observed during the study and no mortality occurred. No staining produced by the test item was observed. Neither alterations of the treated skin were observed nor were corrosive effects evident. Body weights of all rabbits were considered to be within the normal range of variability.
Scaling was observed in all three test animals on days 7 and 10; scaling was observed in test animal numbers 91 and 93 at day 14.
Any other information on results incl. tables
Table 1: Skin Irritation Scores - Individual Values
Animal Number |
Sex |
Evaluation Interval* |
Erythema |
Oedema |
Scaling |
91 |
M |
1 hour |
2 |
2 |
0 |
92 |
F |
1 hour |
4 |
3 |
0 |
93 |
F |
1 hour |
2 |
2 |
0 |
91 |
M |
24 hours |
2 |
1 |
0 |
92 |
F |
24 hours |
3 |
2 |
0 |
93 |
F |
24 hours |
2 |
0 |
0 |
91 |
M |
48 hours |
2 |
1 |
0 |
92 |
F |
48 hours |
3 |
1 |
0 |
93 |
F |
48 hours |
2 |
0 |
0 |
91 |
M |
72 hours |
2 |
1 |
0 |
92 |
F |
72 hours |
2 |
1 |
0 |
93 |
F |
72 hours |
1 |
0 |
0 |
91 |
M |
7 days |
1 |
0 |
X |
92 |
F |
7 days |
1 |
0 |
X |
93 |
F |
7 days |
1 |
0 |
X |
91 |
M |
10 days |
1 |
0 |
X |
92 |
F |
10 days |
1 |
0 |
X |
93 |
F |
10 days |
1 |
0 |
X |
91 |
M |
14 days |
0 |
0 |
X |
92 |
F |
14 days |
0 |
0 |
0 |
93 |
F |
14 days |
0 |
0 |
X |
*Examinations were performed at the specified times after removal of the dressing.
x=scaling present
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance was found to be irritating based on erythema, but not irritating based on edema. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), T263 is considered to be "irritating" to rabbit skin.
The test substance is found to be category 2 'irritating' based on the persistance of scaling in 2 out of 3 animals up to the end of the 14 days observation period.
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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