Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 March 2014 to 10 April 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan:(WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 weeks (at test item administration)
- Weight at study initiation: females 182 – 193 g
- Fasting period before study: overnight
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 – 24.1 °C
- Humidity (%): 32-59%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26.03.2014 To: 10.04.2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): BCBJ7623V - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 female animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily thereafter
- Frequency of weighing: on -1day, 0 day and 7 day
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to a necropsy and a macroscopic examination.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Oxophos 64i did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with Oxophos 64i at the dose level of 2000 mg/kg bw did not cause any clinical signs during the 14 days observation period.
- Gross pathology:
- No macroscopic observations were present at a dose level of 2000 mg/kg bw
Any other information on results incl. tables
Animal supplier: Harlan Laboratories S.r.l., S.Pietro al Natisone (UD), Zona Industriale Azzida, 57 33040, Italy
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Oxophos 64i was found to be above 2000 mg/kg bw in female
RccHan:(WIST) rats.
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