Registration Dossier
Registration Dossier
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EC number: 206-245-1 | CAS number: 314-40-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bromacil
- EC Number:
- 206-245-1
- EC Name:
- Bromacil
- Cas Number:
- 314-40-9
- Molecular formula:
- C9H13BrN2O2
- IUPAC Name:
- 5-bromo-3-sec-butyl-6-methylpyrimidine-2,4(1H,3H)-dione
Constituent 1
- Specific details on test material used for the study:
- Purity: 97.27%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
Animal rooms were maintained at a temperature of 16-22°C and a relative humidity of 30-70%.
Animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.
The rabbits were offered approximately 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study. Water was available ad libitum.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of bromacil, moistened with 0.4 mL of deionized water to form a thick paste
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 60 minutes after removal of the test patches, the test sites were evaluated.
Additional evaluations were made at approximately 24, 48, and 72 hours after removal of the patches. - Number of animals:
- 3 female rabbits
- Details on study design:
- Area of exposure: approximately 6 cm²
Test site was covered with a 2-ply gauze pad
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The objective of this study was to evaluate the skin irritation/corrosive potential and the reversibility of dermal effects of bromacil following a 4-hour dermal exposure in albino rabbits.
The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed, and no body weight loss occurred.
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