Registration Dossier
Registration Dossier
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EC number: 939-634-6 | CAS number: 262368-30-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 february - 22 february 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- CDBB 0213 BS
- IUPAC Name:
- CDBB 0213 BS
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CDBB 0213 BS
- Physical state: light pink powder
- Analytical purity: 100 % (HPLC)
- Purity test date: 19 december 2001
- Lot/batch No.: PKLSCH00630A
- Expiration date of the lot/batch: 5 december 2002
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Laboratory Service, Boehringer Ingelheim Pharma Gmbh & Co. KG, Biberach
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: The animals were housed individually in rabbit cages.
- Diet (e.g. ad libitum): Nafag THO-5; Eberle Nafag AG, Gossau Switzerland ad libitum
- Water (e.g. ad libitum): muncipial drinking water ad libitum
- Acclimation period: approx. 3 weeks, including a 4 day pre-test period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): approx. 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 9/15 hours; 7 am - 4 pm
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- ca. 500 mg of the test substance
- Duration of treatment / exposure:
- 3 minutes, 1 and 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 4 females (including 1 extra animal)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm², skin on the back of the rabbit
- Type of wrap if used: gauze patch, non-skin-irritating tape
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
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