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Registration Dossier
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EC number: 943-336-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 January 1991 to 31 January 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- Perfluorohexane
- IUPAC Name:
- Perfluorohexane
- Details on test material:
- - Name of test material (as cited in study report):T-5333
- Substance type: Clear colorless liquid
- Storage condition of test material: Stored at 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: Hazelton Research Produts, Inc., Kalamazoo MI
- Age at study initiation: Adult
- Weight at study initiation: 2,108 to 2,494 g
- Housing: Individually, in screen-bottom stainless steel cages
- Diet (e.g. ad libitum): Measured amount of High Fiber Rabbit Chow #5326 (Purina Mills, Inc.)
- Water (e.g. ad libitum): ad libitum
- Acclimation period:At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-21.7 degrees Celsius
- Humidity (%): 33-44
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:28 January 1991 To:31 January 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after exposure
- Number of animals:
- 1 male, 2 female
- Details on study design:
- TEST SITE
- Area of exposure: Back and flanks of rabbits
- % coverage: 100
- Type of wrap if used: Saran Wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Degree of erythema and edema was read according to the Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation or corrosion was observed during the 72 hour observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Application of the test article to the skin of rabbits under 4-hour semioccluded conditions resulted in no erthema or edema reactions. The average ofthe 4-, 24-, 48-, and 72-hour scores is 0. The test article is considered to be nonirritating.
- Executive summary:
A primary dermal irritation study was conducted according to OECD guideline 404. One male and two female acclimated animals were selected and maintained during the study period. Within 24 hours before treatment, the hair was clipped from the back and flanks of each animal. The test article was applied to the shaved intact skin on each animal's back in the amount of 0.5 mL. the area of application was covered with 2.5-cm x 2.5-cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap to provide a semiocclusive dressing. At the end of the 4-hour exposure period the patches were removed and the test sites washed with tap water. Thirty minutes after removal of the test material, the degree of erythema and edema was read according to the Draize technique (recorded as the 4-hour score). Subsequent examinations were made at 24, 48, and 72 hours after patch removal. The average of the 4, 24, 48, and 72 hour scores was 0. The test article is considered to be nonirritating.
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