Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Mar 2004 to 09 Jul 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
December 17, 2001
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
September 20, 1996
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 202
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.
Specific details on test material used for the study:
TEST MATERIAL
- Name of the test substance used in the study report: DKDS - Reinkristallisat
- Purity: 96.8 w/w%
- Batch No.: CP 203-362-04-02
- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. The stability under storage conditions was confirmed by reanalysis

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HanBrl:WIST(SPF)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd., Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approx 8-12 weeks
- Weight at study initiation: 179 - 191 g
- Fasting before period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Drinking water: Tap water ad libitum
- Acclimatization: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Central air-conditioning guaranteed a range of 20 - 24°C
- Humidity: 30 - 70% relative humidity
- Photoperiod: 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Preparation: The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer.
- Form of administration: suspension
- Amount of vehicle: 100 mL
- Justification for choice of vehicle: The aqueous formulation corresponds to the physiological medium.
- Concentration used: 20g/100 mL.
- Administration volume: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2,000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animais. As none of those animals died, 2,000 mg/kg body weight were administered to another group of 3 female animais in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Observation period: At least 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.

Results and discussion

Effect levels
Key result
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 and findings were observed.
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 animais examined at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met