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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
