Registration Dossier
Registration Dossier
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EC number: 485-390-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-06-07 to 2006-11-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD test guideline 423
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
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 Deutschland GmbH, D-97633 Sulzfeld
- Weight at study initiation: 148 g - 177 g
- Housing: transparent macrolone cages (type 3-180, floor area 810 cm2) with two or three rats/cage
- Diet: Altromin 1314" from Altromin GmbH, D-32791 Lage; ad libitum
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: > 30 - < 70 %
- Air changes: 10 times/hour
- Photoperiod: 12h dark/12h ligtht, light from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered orally by gavage to rats fasted overnight prior to dosing. After dosing diet was withheld for 4 more hours.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min, 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- 2 female rats: LD50 > 2000 mg/kg bw
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- none
- Body weight:
- normal gain
- Gross pathology:
- gross necropsy revealed no pathological abnormalities
Applicant's summary and conclusion
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