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Registration Dossier
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EC number: 406-600-2 | CAS number: 89392-03-0 DPX-E6758
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 203 - 228 g / females: 165 - 184 g
- Shaving: one day before exposure
- Housing: individual housing in polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (Kliba 343 from KlingentalmOhle AG, Kaiseraugst, Switzerland).
- 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
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
Area of exposure: formulation was applied to an area of approx. 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum
TEST MATERIAL / VEHICLE
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Dose volume:10 ml/kg body weight.
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration:
- mortality: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
- body weights: days 1, 8 and 15
- symptoms: at periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- not performed
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mglkg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mglkg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Neither clinical signs of toxicity nor local effects such as irritation of treated skin area were observed.
- Gross pathology:
- No treatment-related macroscopic findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal toxicity LD50 on rats was found to be > 2000 mg/kg.
- Executive summary:
The study was performed according to the standard method EU B.2 on Wistar rats with a single dose of 2000 mg/kg. Five animals were used per sex. The animals were treated dermally by semi-occlusive application of an aqueous suspension of the the test material. The LD50 was determined to be > 2000 mg/kg; therefore, the test item does not have any classification/labelling requirements.
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