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:
- from 15 April 2013 to 21 August 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17-DEC-2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier (53940 Le Genest St Isle, France)
- Females nulliparous and non-pregnant: no data
- Age at study initiation: 8 weeks old
- Weight at study initiation: between 191 and 200 g
- Fasting period before study: no data
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid, with sawdust bedding which was changed at least 2 times a week.
- Historical data: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: 13 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 23 April 2013 To: 08 May 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g in 10 mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily or on D0, 2, 7 and 14 for weighing
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- no clinical signs
- Body weight:
- absence of body weight gain between day 2 and day 7 (compared to historical control), but normal therafter
- Gross pathology:
- no effect observed at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- oral LD50 > 2000 mg/kg (rat, female, gavage in corn oil)
- Executive summary:
In an acute oral toxicity study, groups of 8-week old Sprague-Dawley rats (6 females) were given a single oral dose of test substance in corn oil at dose 2000 mg/kg bw and observed for 14 days.
Oral LD50 Females > 2000 mg/kg bw
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