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EC number: 605-398-5 | CAS number: 16524-65-5
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-08-09 to 2006-08-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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)
Test material
- Reference substance name:
- (2S)-2-[(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-11,15-dimethoxy-13-oxa-3-azahexacyclo[13.2.2.1²,⁸.0¹,⁶.0⁶,¹⁴.0⁷,¹²]icosa-7,9,11-trien-16-yl]-3,3-dimethylbutan-2-ol
- Cas Number:
- 16524-65-5
- Molecular formula:
- C30H43NO4
- IUPAC Name:
- (2S)-2-[(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-11,15-dimethoxy-13-oxa-3-azahexacyclo[13.2.2.1²,⁸.0¹,⁶.0⁶,¹⁴.0⁷,¹²]icosa-7,9,11-trien-16-yl]-3,3-dimethylbutan-2-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-18163678-AAA (T002713)
- 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:00477910RT002713G4A051
- Expiration date of the lot/batch:2006-12-03
- 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: Stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle:No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harland Netherlands BV
- Age at study initiation: males, 13-14 weeks; females, 11-12 weeks
- Weight at study initiation: females: 2065 g, 2228 g, male: 2582 g
- Housing: Animals were housed individually in stainless steel cages with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 batch 08/07 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Füllinsdorf community tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2006-08-09 To: 2006-08-21
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- purified water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of T002713 moistened with approx. 0.5 mL purified water - 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:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- % coverage: no data
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin flushed with lukewarm water.
- Time after start of exposure: 4 hours
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:
- mean
- Remarks:
- (animal 55)
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 55)
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 56)
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 56)
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 57)
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
- Other effects:
- VIABILITY/MORTALITY
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
COLORATION
-No staining by the test substance was observed.
CORROSION
-Neither alterations nor corrosion of the skin were evident.
BODY WEIGHTS
-The body weights of all animals 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), T002713 is considered to be "not irritating" to rabbit skin.
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