Registration Dossier

Administrative data

Description of key information

The oral LD50 for rats was determined to be >2000 mg/kg bw. No mortality was observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
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
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- Fasting before period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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
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.
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.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an Acute Toxic Class Method study performed according to OECD 423 under GLP conditions, the acute oral toxicity of the test substance to rats was assessed. A group of three fasted female Wistar rats were exposed to the test substance at a dose of 2000 mg/kg bw by gavage in one administration as a first step. As no mortaility was observed, another group of three fasted female Wistar rats were exposed to the test substance at a the same dose in one administration by gavage. After an observation period of 14 days, animals were necropsied. No mortality occurred in both groups and no clinical signs and findings were observed. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. The LD50 was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.