Registration Dossier
Registration Dossier
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EC number: 607-952-1 | CAS number: 2653-16-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 - 23 Feburary 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and according to an OECD guideline (see below).
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- CDBE 0055 XX
- IUPAC Name:
- CDBE 0055 XX
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CDBE 0055 XX
- Physical state: light beige crystal powder
- Purity test date: 19 Dec 2001
- Lot/batch No.: PKLHUC00799
- Expiration date of the lot/batch: 21 Nov 2002
- Stability under test conditions: yes
- 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 & Co. KG, Biberach, Germany
- Age at study initiation: 11 -12 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in rabbit cages
- Diet (e.g. ad libitum): pellets ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs light / hrs dark): 9/15 hrs
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): An amount of 5g of the test article was moistened with the smalles amount of vehicle needed to ensure good skin contact. An amount of 500 mg (or slightly more) of the moistened test article was used for each application site. - Duration of treatment / exposure:
- 1. test site 3 minutes
2. test site 4 hrs
3. test site 1 hour - Observation period:
- 60 minutes, 24, 48 and 72 hours after end of treatment.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: three skin sites of each approx. 6cm²
- Type of wrap if used: the sites were covered with gauze patch and held in place with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using luke-warm water.
SCORING SYSTEM:
as described in OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
The general clinical appearance of all animals was normal throughout the study. All animals had a normal appearance of the skin during the entire study. No erythema or edema were observed for any animal at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal exposure of Chbb:NZW rabbits to approximately 500 mg CDBE 0055 XX on 6cm2 skin for up to 4 hours did not cause erythema or edema in any animal at any time point. Therefore, the test substance is considered non-irritating and non-corrosive.
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