Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
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)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Office of Public Health Consumer Protection, Directorate Notification Authority, Head: Dr. Dag Kappes.
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF SE, 33470-153 FK
- Expiration date of the lot/batch: Shelf life: unlimited.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:ambient temperature (RT), protected against moisture and daylight.
- Stability under test conditions: The stability of the test substance under Storage conditions over the test period was guaranteed by the sponsor.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test substance was diluted in corn oil
- Final dilution of a dissolved solid, stock liquid or gel: 500 mg/mL

FORM AS APPLIED IN THE TEST (if different from that of starting material): suspension in corn oil

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: 9 weeks.
- Weight at study initiation: The weight variation of animals was not greater than 20 percent of the mean weight (196.2 g).
- Fasting period before study: Animals were fasted (food but not water was withheld ovemight) prior to the test substance administration.
- Housing: Animals were housed using conventional polypropilene rodent cages (Beiramar, CXBHG, 41 x 34 X 16 cm) with three animals per cage.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C.
- Humidity (%): 64%.
- Photoperiod (hrs dark / hrs light): 12 hours/day.

IN-LIFE DATES: From: 01 August 2007 To: 15 August 2007 and From: 02 August 2007 To: 16 August 2007.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Request of the Sponsor.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Remarks:
not apllicable
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded shortly before administration, weekly thereafter and at the end of the study. Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1). Signs and symptoms were recorded at least once each workday for individual animals. A check for dead or moribund animals were made at least once each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
No adverse effects observed.
Mortality:
No mortality was observed arnong the tested animals.
Clinical signs:
No treatment related signs were observed during the first 4 hours after a single administration of the test material or during the observation period (14 days).
Body weight:
Body weight changes were within the range of physiological variability.
Gross pathology:
No macroscopic changes were observed in any of the major Organs of the examined animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is considered to be not acute toxic by the oral route in the OECD 423 study. The LD50 of the test material was estimated to be > 2000mg/kg bw in rats.
Executive summary:

The present study was carried out to assess acute toxicity following a single oral administration to rats of the test substance.Wistar rats were selected and maintained under controlled environmental conditions. Based on individual body weight, dosing of the test substance was calculated in mg/kg body weight (bw). Two groups of three female rats received 2000mg/kg bw of the test substance diluted in corn oil by oral gavage. No mortality or signs of evident toxicity were observed during the first 4 hours after test substance administration or during the observation period (14 days). Gross pathology examination was performed in all tested animals. No macroscopic alterations were observed in any of the major organs of the examined animals. According to the decision tree of the OECD-Guideline, the LD50oral of the test material was estimated to be > 2000mg/kg bw in rats.