Registration Dossier
Registration Dossier
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EC number: 617-441-5 | CAS number: 83121-18-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 October 1983 to 7 October 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP statement dates to Dec 18, 1987 Study report dates to Oct 14, 1983
Test material
- Reference substance name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 617-441-5
- Cas Number:
- 83121-18-0
- Molecular formula:
- C14 H6 Cl2 F4 N2 O2
- IUPAC Name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: The animals were caged individually in stainless steel cages
- Diet: ad libitum, pelleted standard Kliba 341, rabbit maintenance diet
- Water: ad libitum, tap water
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of the moistened (tap water) test substance
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: on the dorsum of each rabbit
- Test patch approximately 3.0 cm x 3.0 cm
- Type of wrap: impermeable material and fastened to the body with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h (at the end of the exposure period)
OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1 hour, 24, 48, 72 hours following removal of bandages and gauze patch.
SCORING SYSTEM:
A numerical scoring system according to Draize J.H. 1959 was used to grade the skin lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: #32
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #32
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #33
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #33
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #34
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #34
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance showed a primary irritation index of 0 when applied to intact rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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