Registration Dossier
Registration Dossier
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EC number: 207-028-4 | CAS number: 423-55-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May 1990 - 11 June 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Internal, similar to OECD 404
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-bromoheptadecafluorooctane
- EC Number:
- 207-028-4
- EC Name:
- 1-bromoheptadecafluorooctane
- Cas Number:
- 423-55-2
- Molecular formula:
- C8BrF17
- IUPAC Name:
- 1-bromoheptadecafluorooctane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Physical state/Appearance: Clear colourless liquidStorage condition of test material: Room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age of aniamls at study initiation: AdultWeight at study initiation: 2.0 -3.5 kgAcclimation period: At least 7 days Environmental controls for the animal room was set to maintain a temperature of 70 deg F ±3 deg F, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,5 mL
- Duration of treatment / exposure:
- 24 h exposure
- Observation period:
- 72 h
- Number of animals:
- 3 male and 3 female
- Details on study design:
- Test material was applied to two shaved test sites on each animal. Just before the test material was applied, crisscross epidermal abrasion were made on one of the exposed areas on each rabbit. The abrasions penetrated stratum corneum but they were not deep enough to penetrate the dermal layer and cause bleeding. Each treated area was covered with a gauze patch for 24 hours. The test site was washed with water after the 24h exposure period. Erythema and oedema was scored according to the Draize technique 30 minutes after the removal of the test material (24h). This was followed by a second reading after 72h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No signs of skin irritation were noted in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary dermal irritation of Imagent GI (PFOB) to the skin of rabbits was evaluated. The material produced no erythema or edema reactions. The primary dermal irritation index (the sum of the 24- and 72-hour scores divided by two) was determined to be 0.0, meaning that the material is not a primary skin irritant when tested by this method.
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