Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2005 to January 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
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
Remarks:
Han: WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (101 - 117 g); females (102 - 110 g)
- Fasting period before study: approximately 18-19 hours
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 55 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 9.0 mg NaCl + 0.85 mg Myrj 53 ad 1 mL water for injection (Ampuwa)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: I: N1630A01, II: N1637A01

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: at least once daily (clinical observation), once weekly (body weight)
- Necropsy of survivors performed: yes
Statistics:
none (limit test)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
No compound-related findings occurred.
Body weight:
A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No compound-related effect on body weight gain was observed in male animals.
Gross pathology:
No treatment-related findings were observed.

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test substance was low with a LD50 (cut-off value) > 2000 mg/kg bw in rats according to OECD TG 423. A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No effect on body weight gain occured in male rats. Administration was tolerated without mortalities, clinical findings and gross pathological findings.