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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-01-29 until 2003-02-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Uvinul A Plus
- The test substance is pasty melt (occasionally solidified) at room temperature and has a yelllow colour. After melting at about 60°C, the test substance is liquid, high viscous with a yellow colour.
- Lot/batch No.: 30956/121D2+/122D stripped
- Degree of purity: 97.9 w% (analytical report: 02L00421)
- Name of test material (as cited in study report): Uvinul A Plus
-The stability of the test substance in the vehicle for a time period of 96 hours was confirmed by analysis. The homogeneity of the test substance preparation in the vehicle used for the first administration was confirmed by analysis.
- Kept in room temperature, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld; Germany
- Age at study initiation: Young adult animals - approx. 14- 18 weeks
- Weight at study initiation: 195 g mean weight in the first experiment and 201g in the following experiment
- Fasting: Feed was withdrawn from the animals at least 16 hours before administration of the test substance.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation for at least 5 days

ENVIRONMENTAL CONDITIONS
-The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range of 20 - 24°C and of 30- 70% relative humidity.
- Photoperiod (hrs dark / hrs light): 12 h /12 h

IN-LIFE DATES: From: 2003-01-30 (first administration) To: 2003-02-19

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE- Olive oil Ph.Eur./DAB
- Concentration in vehicle: 40 g test substance / 100 mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION:
The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer. For a better handling the test substance was melted at about 60°C. The preparation was cooled down to body temperature.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The selection of dose was based on the physical and chemical characteristics of the test substance and its composition. As no pronounced acute oral toxicity was expected, a starting dose of 2,000 mg/kg body weight has been chosen to be given to 3 animals of a single sex per step (as instructed by the OECD 423 guideline for a acute toxic class method).
Regarding the use of the class method in the study: As none of those animals died, 2,000 mg/kg body weight were administered to another group of 3 female animals 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:
In total: 6 female animals at 2000 mg/kg.
3 female animals in the first step (first experiment)
3 female animals in the second step (second experiment)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms were done at least once a day. Individual body weights was measured shortly before administration (day 0), after one week and at the end of the study. A check for any dead or moribund animal was made twice a day.
- Necropsy with gross-pathology examination was done on the last day of the observation period after killing the animals with CO2.
Statistics:
Not indicated (regarding body weight)

Results and discussion

Preliminary study:
There was no need of a preliminary study. The study was performed according to the Acute Toxic Class method
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No clinical observations were noticed during the clinical examinations.
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 6 examined animals.
Other findings:
No other findings.

Any other information on results incl. tables

No remarks.

Applicant's summary and conclusion