Registration Dossier
Registration Dossier
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EC number: 601-478-9 | CAS number: 117428-22-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl)pyridin-2-yloxymethyl]phenyl}acrylate
- EC Number:
- 601-478-9
- Cas Number:
- 117428-22-5
- Molecular formula:
- C18H16F3NO4
- IUPAC Name:
- methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl)pyridin-2-yloxymethyl]phenyl}acrylate
- Test material form:
- solid
- Details on test material:
- Purity: 99.66%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania.
- Weight at study initiation: 3003 to 3583 g
- Housing: All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: Approximately 125 grams/day
- Water: ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-22°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Deionized water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Approximately 0.5 g of the test substance, moistened with 0.3 mL of deionized water to form a thick paste, was applied to the test site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 (males)
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm²
- Type of wrap if used: The 2-ply gauze pad was held in place with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was further secured with waterproof tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, with warm water
- Time after start of exposure: Approximately 4 hours
OBSERVATION TIME POINTS
Test sites were evaluated by Draize for signs of dermal irritation approximately 60 minutes, and 24, 48, and 72 hours after test substance removal.
SCORING SYSTEM:
- Method of calculation: Draize Scale for Scoring Skin Irritation, 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The rabbits exhibited no dermal irritation during the study.
- Other effects:
- No clinical signs of toxicity were observed, and no biologically important body weight loss occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non irritant
- Executive summary:
The test substance was applied as a single 0.5-g 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, moistened with 0.3 mL of deionized water, 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, and no biologically important body weight loss occurred.
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