Registration Dossier
Registration Dossier
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EC number: 220-860-2 | CAS number: 2920-38-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- p-phenylbenzonitrile
- EC Number:
- 220-860-2
- EC Name:
- p-phenylbenzonitrile
- Cas Number:
- 2920-38-9
- Molecular formula:
- C13H9N
- IUPAC Name:
- biphenyl-4-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): p-Phenylbenzonitrile
- Physical state: Solid / white
- Analytical purity: 96.0 G%/G%
- Lot/batch No.: 0005797001
- Expiration date of the lot/batch: March 18, 2017
- Stability under test conditions: stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: 210 - 237 g
- Fasting period before study: not applicable
- Housing: individual cages
- Diet (e.g. ad libitum): ad libititum
- Water (e.g. ad libitum): ad libititum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fapprox 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-04-24 To: 2012-05-16
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5% solution of CMC (sodium carboxymethylcellulose) in deionized water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 and 5 g/kg bw
- Concentration (if solution): 40g/100 ml (Suspension (Paste))
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- single
- Doses:
- 2000 mg/kg bw and 1000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. The evaluation of skin reactions was performed according to Draize, J.H. (1959) - Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- None
- Clinical signs:
- No systemic clinical signs were observed during clinical examination.
No local effects were observed. - Body weight:
- No changes in body weight were observed.
- Gross pathology:
- No adverse findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- None of the rats treated with a single dose of 2000 mg/kg bw showed signs of intoxication during the 14-day observation period.
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