Registration Dossier

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 02, 2003 to April 17, 2003
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guidelineopen allclose all
according to
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
according to
EPA OPPTS 870.1100 (Acute Oral Toxicity)
according to
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Test material form:
Details on test material:
CAS: 078567-28-9
Specific details on test material used for the study:
CAS No.: 078567-28-9; Batch No.: WDJ 1853 D-3; Appearance: yellowish liquid

Test animals

Details on test animals and environmental conditions:
The used strain was HsdCpb:Wu (breeder: Harlan/Winkelmann GmbH, Borchen, Germany). Animals of this strain have been used at Bayer AG, Bayer HealthCare for toxicological studies for many years. Historical data on their physiology and spontaneous alterations is available. The state of health of the breeding colony is routinely spot-checked for the main specific pathogens. The results of these examinations are archived.
At start of the study the animals were nulliparous and non-pregnant and free of all clinical symptoms or diseases. The acclimatization time in the animal room was at least 5 days.
Body weights at start of study: 144 g - 162 g.
This is according to an age of 9 - 10 weeks approximately.
If necessary (quantity delivered ≥than needed for two groups) the animals were assigned to their groups by randomization. The random lists are based on evenly distributed chance numbers by a software application. The animals were identified by labels on the cages stating study number, test compound, animal number, group number, etc. and by individual animal identification using permanent skin marking.

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
The individual administration volumes were calculated on the base of the body weight at time of administration. For administration, food was withheld from the animals for approximately 16 - 24 h before administration of the test compound, and they were fed again approximately 2 - 4 h after administration. The administration volume was 5 ml/kg body weight.
The analytical data verify that the test compound formulations are stable at room temperature for at least 4 hours and are homogeneously distributed.
Housing conditions:
Room temperature: 22±2 °C
Air humidity: 55±5 %
Ventilation: approx. 10 changes per hour
Light/dark cycle: 12 hour rhythm
The animals received the standard diet “Provimi Kliba 3883.0.15 Maus/Ratte and tap water ad libitum from polycarbonate bottles. The nutritive composition and the contaminant content of the standard diet were checked and analysed routinely in random samples.
The animals were grouped caged conventionally in polycarbonate cages on low dust wood granulate bedding.
The dose level to be used as the starting dose was selected from one of four fixed levels: 5, 50, 300 and 2000 mg/kg bw. The starting dose should be that which is most likely to produce mortality in some of the dosed animals.
- Dosing of three animals with the same dose
- Dosing of three additional animals at the next higher or the next lower dose level.
The substance is tested using a stepwise procedure, each step using three animals of a single sex.
No. of animals per sex per dose:
Details on study design:
The signs of poisoning and mortality rates were determined several times on the day of administration and subsequently at least once daily for an observation period of 14 days. Mortality and in the event of symptoms occurring, duration, nature and intensity were recorded.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
No mortalities occurred.
Clinical signs:
No clinical signs were observed.
Body weight:
There were no toxicological effects on body weights or on body weight gain.
Gross pathology:
The necropsies performed at the end of the study reviled no particular findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Under the study conditions, the acute oral LD50 of the substance in female Wistar rats was determined to be greater than 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the substance in female Wistar rats according to OECD Guideline 423, EU Method B.1 tris and OPPTS 870.1100. The test substance was formulated in corn oil and the administration volume was 5 mL/kg bw. The single dose of 2000 mg/kg bw of the test substance was tolerated by the treated rats without mortalities, clinical signs, effects on body weight development and gross pathological findings during 14 days observation period. Under the study conditions, the acute oral LD50 of the substance in female Wistar rats was determined to be greater than 2000 mg/kg bw (Schungel, 2003).