Registration Dossier
Registration Dossier
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EC number: 406-600-2 | CAS number: 89392-03-0 DPX-E6758
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate
- EC Number:
- 406-600-2
- EC Name:
- Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate
- Cas Number:
- 89392-03-0
- Molecular formula:
- C13H13N3O4
- IUPAC Name:
- phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate
- Test material form:
- solid: crystalline
- Details on test material:
- - Identification: IN-E6758
- Description: Off white to light blue solid
- Batch: E52691-89-3-B22
- Purity: approx. 100%
- Expiry date: not indicated
- Storage: at room temperature in a cool place in the dark (avoid high temperatures)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2140 - 2377 grams
- Housing: individually in cages with perforated floors equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (lKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 g/d
- Water (e.g. ad libitum): Tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: approx. 100 cm2
On test day 1, 0.5 gram of the moistened test substance was applied to the intact skin of the shaved area on one flank, using a Metalline patch (2x3 cm, Lohman, Neuwied, W.-Germany) mounted to Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test article and vehicle) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, st. Paul, U.S.A.). Four hours after the application, the dressing was removed and the remaining test article was removed using a tissue moistened with tap-water and subsequently a dry tissue.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: overall 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: overall 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin irritation was observed.
- Other effects:
- No staining of the treated skin by the test substance was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be non-irritating to rabbit skin.
- Executive summary:
The study was performed according to EU-method B.4 on three New Zealand White rabbits. Neither erythema nor oedema were observed throughout the test (score 0), therefore, the test substance can be considered as non-irritant to rabbit skin.
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