Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov - Dec 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Landesanstalt für Pflanzenbau und Pflanzenschutz - Rheinland Pfalz, signed on 24 Sep. 2001
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: RCC Ltd., Füllinsdorf, Switzerland
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 182 g (mean body weight)
- Fasting period before study: at least 16 hours before administration, water was available ad libitum
- Housing: individually in stainless steel wire mesh cages, type DK-III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 g/100 ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
- Purity: doubly distilled water


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg
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: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
without findings or clinical signs
Body weight:
The mean body weights of the administration groups increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (2,000 mg/kg, 6 females) examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 2,000 mg/kg body weight in rats.
Executive summary:

The study was performed to assess the acute toxicity following oral administration in Wistar rats in a GLP-compliant study performed according OECD 423 guideline.

Single doses of 2,000 mg/kg body weight of test material preparations in doubly distilled water were given to two administration groups of three fasted female animals, each, by gavage in a sequential manner. After an observation period of 14 days no mortality occurred. Moreover, no clinical signs were observed. The mean body weights of the administration groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals of the 2,000 mg/kg administration group examined at the end of the observation period.

Under the conditions of this study, the median lethal dose of the test item after oral administration was found to be greater than 2,000 mg/kg body weight in rats.