Registration Dossier
Registration Dossier
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EC number: 700-651-7 | CAS number: 692-49-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted according to guidelines and was GLP. However, the substance has a BP of approximately 30°C and would exist as a vapour at biological temperatures. Therefore, a reliable skin irritation test is not feasible for this substance, based on physical-chemical properties.
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)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2Z)-1,1,1,4,4,4-hexafluorobut-2-ene
- EC Number:
- 700-651-7
- Cas Number:
- 692-49-9
- Molecular formula:
- C4H2F6
- IUPAC Name:
- (2Z)-1,1,1,4,4,4-hexafluorobut-2-ene
- Details on test material:
- - Purity: 100% (based on GC analysis)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent areas of untreated skin were used for comparison.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0 - 72 hours after removal of test substance
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0 - 72 hours after test substance removal
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No clinical signs of toxicity were observed. One of the rabbits exhibited weight loss of approximately 2% of initial weight by 3 days after dosing. No weight loss was observed in the other rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the test substance is not a skin irritant.
- Executive summary:
The test substance was applied as a single 0.5-mL dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance was applied to a 6 cm2 area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated by Draize for signs of dermal irritation approximately 60 minutes, and 24, 48, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal.
The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed. One of the rabbits exhibited body weight loss of approximately 2% of initial weight by 3 days after dosing. No weight loss was observed in the other rabbit. Under the conditions of this study, the test substance is not a skin irritant.
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