Registration Dossier

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:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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