Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

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 Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 170 - 180 g
- Fasting period before study: at least 16 hours before administration, but water was available ad libitum
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P) (SDS Special Diets Services, Altrip, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- Humidity (%): 20 – 80
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % CMC-solution (cleaned sodium carboxymethylcellulose) in doubly distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/lg bw

DOSAGE PREPARATION: The test-item preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test-item preparation during application was provided by stirring with a magnetic stirrer.

CLASS METHOD
- Rationale for the selection of the starting dose: By the request of the sponsor a starting dose of 50 mg/kg bw was chosen in the first step with 3 female animals. No animal died. 300 mg/kg bw was administered to 3 female rats in the second step. Because no animal died at the second step, 2000 mg/kg bw was administered to another group of 3 female animals in the third step. As no animal died in the third step, 2000 mg/kg was administered in the fourth step. As no animal died in the fourth step the study was terminated.
Doses:
50, 300, 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: 14 days
- Frequency of observations and weighing: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animal was made at least once each workday. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes, with gross-pathology examination on the last day of the observation period after sacrificed by CO2-inhalation in a chamber with increasing concentrations over time.
- Other examinations performed: No histological examinations were performed.

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:
No clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU