Registration Dossier
Registration Dossier
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EC number: 482-400-9 | CAS number: 138776-88-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 june - 27 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay, Labor fuer biologische Analytik GmbH, Heidelberg, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): L4-Ligand
- Physical state: white solid
- Analytical purity: 97.0g/100g ± 0.3g/100g
- Lot/batch No.: 0005473663
- Expiration date of the lot/batch: 01 February, 2013
- Storage condition of test material: room temperature, under N2, protected against humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: mean (administration 1) 186.3g ± 4.04g, mean (adminsitration 2) 181.0g ± 3.61g
- Fasting period before study: 16 hours
- Housing: single housing in Makrolon Type III cages
- Diet: VRF1 (P); SDS Special Diets Services, Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.4g/mL
- Amount of vehicle: 5 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: approximately 1 mL
DOSAGE PREPARATION: stirring with a homogenizer and a magnetic stirrer to ensure homogeneity
CLASS METHOD
- Rationale for the selection of the starting dose: by request of the sponsor - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (sequential testing of 2 groups)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for clinical signs are done several time on the day of application and daily thereafter on workdays, individual body weights were determined before administration and on day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortalities were observed
- Mortality:
- No mortality occured in both test groups.
- Clinical signs:
- other: No clinical signs were observed for both test groups.
- Gross pathology:
- There were no macroscopic pathological findings at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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