Registration Dossier
Registration Dossier
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EC number: 919-003-1 | CAS number: 1174335-83-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 January - 04 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD ) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- PD 283 XX
- IUPAC Name:
- PD 283 XX
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PD 283 XX
- Physical state: yellow powder
- Analytical purity: 97.6 % (HPLC)
- Analysis test date: 12 january 2006
- Purity to be retested: january 2007
- Lot/batch No.: V12TFA00072
- Storage condition of test material: 20°C
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 of Boehringer Ingelheim Pharma GmbH & Co. KG
- Age at study initiation: approximately 6 - 12 months
- Weight at study initiation: 3.3 – 4.4 kg (day of application)
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): Dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland), ad libitum
- Water (e.g. ad libitum): municipal drinking water were supplied ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2°C
- Humidity (%): 45-75 %
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- ca. 500 mg per animal
- Duration of treatment / exposure:
- 1 female: 3 min, 1h and 4 hours
2 females: 4h - Observation period:
- 1 h, 24 h, 48 h, 72 h after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm², dorsal skin of the rabbit
- Type of wrap if used: muslin tissue, non-skin-irritating plaster
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study PD 283 XX was well tolerated subsequent to topical application on rabbit
skin. There were no macroscopic signs of irritation or corrosion. In addition, there were no
signs of systemic side effects or of skin alterations beyond the area of exposure.
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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