Registration Dossier
Registration Dossier
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EC number: 619-598-5 | CAS number: 915095-87-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August - 21 September 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane
- EC Number:
- 619-598-5
- Cas Number:
- 915095-87-3
- Molecular formula:
- C17 H14 Cl I O3
- IUPAC Name:
- (3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): IN00078281 (IN 78281)
- Physical state: White powder
- Analytical purity: The Certificate of Analysis was provided to the Study Director
- Lot/batch No.: 7889-058-10
- Expiration date of the lot/batch: Dec 2006
- Stability under test conditions: Stability data on bulk test material was not provided to the Study Director
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Oxford, MI
- Age at study initiation: 19 weeks at start of dosing
- Weight at study initiation: 2.9-3.1 kilograms at the outset (day 1) of the study
- Housing: individually according to USDA guidelines
- Diet (e.g. ad libitum): ad libitum, PMI Certified Hi-Fiber Rabbit Diet #5325
- Water (e.g. ad libitum): ad libitum, tab water
- Acclimation period: study animals were acclimated to their housing for a minimum of five days prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 to 21°C
- Humidity (%): 32 to 72 %
- Air changes (per hr): The room in which the animals were kept was documented in the study records
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.5 ml saline
- Amount / concentration applied:
- 500 mg of the powder test
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 30 -60 minutes through 72 hours
- Number of animals:
- 3 males
- Details on study design:
- Within 24 hours before initiation of the test, fur w removed from he dorsal trunk of each animal by clipping. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. The test article was applied to an area (~5cm x 5cm) on the dorsal trunk of each animal and covered with a gauze patch. The patch was loosely held in contact with the skin with a sheet of rubber dam. The trunk of the animal was wrapped with an elastic bandage dressing, which was held in place with non-irritating tape for a 4-hr exposure period. At the end of the exposure period, residual test article was removed using water and gauze, without altering the existing response or the integrity of the epidermis.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item, was found to be a non-irritant to the skin of rabbits with a Primary Irritation Index score of 0.
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