Registration Dossier
Registration Dossier
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EC number: 700-476-6 | CAS number: 119895-68-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-difluoro-2H-1,3-benzodioxole-4-carbaldehyde
- EC Number:
- 700-476-6
- Cas Number:
- 119895-68-0
- Molecular formula:
- C8H4F2O3
- IUPAC Name:
- 2,2-difluoro-2H-1,3-benzodioxole-4-carbaldehyde
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino rats (Tif: RAI f (SPF))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young
- Weight at study initiation: 215 - 244 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-07-28 To: 1992-08-11
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: d0, d7, d14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- 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/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Piloerection and hunched posture were seen (d0-d2), being common symptoms in acute dermal tests. At the application site, erythema was observed in both sexes, edema in the females. The animals recovered within 3-9 days.
- Gross pathology:
- No abnormalities detected.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- In this acute dermal study in the rat the test item did not cause any mortality up to the limit concentration of 2000 mg/kg bw.
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