Registration Dossier
Registration Dossier
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EC number: 228-250-8 | CAS number: 6197-30-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-04-08 through 1992-04-22
- 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 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 (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octocrilene
- EC Number:
- 228-250-8
- EC Name:
- Octocrilene
- Cas Number:
- 6197-30-4
- Molecular formula:
- C24H27NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyano-3,3-diphenylacrylate
- Details on test material:
- - Name of test material (as cited in study report): HR 92/600154
- Analytical purity: 98.5%
- Impurities (identity and concentrations):
- Physical state: viscous liquid
- Lot/batch No.: 2010002
- Stability under test conditions: yes
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, U.K.
- Age at study initiation: 10 to 14 weeks
- Weight at study initiation: males 213-235 g; females 202-222 g
- Fasting period before study: not required
- Housing: singly until day 1 post treatment, in groups of 5 thereafter
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1)
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 52-60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x4 cm
- % coverage: 10% of total body surface
- Type of wrap if used: surgical gauze, covered by a piece of self-adhesive bandage (HYPERTIE), secured with a piece of BLENDEM wrapped around each end
REMOVAL OF TEST SUBSTANCE
- Washing: with distilled water to remove excess test material
- Time after start of exposure: 24 hours after treatment
TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant volume or concentration used: yes - 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: observations at least once daily; weighing on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not needed
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity or skin irritation were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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