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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:
9 March 1993 to 30 December 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
19 September 1984
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Acute Toxic Class Method (ATC Method) by E. Schlede, U. Mischke, R. Roll, D. Kayser: A National Validation Study of the Acute-Toxic-Class Method - An Alternative to the LD50 Test. Arch. Toxicol. 66: 455-470 (1992).
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: P. 28/93

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach
- Age at study initiation: not spezified (young adult animals)
- Weight at study initiation: mean body weigt of three male animals: 183 g; mean body weight of three female animals: 180 g
- Fasting period before study: no feed at least 16 hrs before administration, but water was available ad libitum
- Housing: single housing
- Diet: Kliba diet 343, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 March 1993 To: 25 March 1993

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle: 5 mL/kg bw
- Justification for choice of vehicle: test substance is insoluble in aqua bidest

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
-Frequency of observation and weighing: animals were checked for mortality twice each workday and once on saturday, sunday and on public holidays for general observations and for any dead or moribund animals. Weighing was performed before application (day 0), weekly thereafter and at the end of the study. Recording of toxicological signs and symptons several times on the day of administration, at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and symptoms, body weight, general observations and mortality, pathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No abnormalities were observed.
Body weight:
Body weight gain during study meets expectations.
Gross pathology:
Necropsy at the end of the study revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met