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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to current guideline studies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Principles of method if other than guideline:
Method: other: BASF test
GLP compliance:
no
Test type:
other: BASF-Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lusantan MCE
- Lot/batch No.: 2/4/83
- Physical state: liquid
- Analytical purity: approx 100%
- Expiration date of the lot/batch: Stability > 2 years

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K Tomae GmbH, Biberach, Germany
- Mean weight at study initiation: 170 g male/190 g female
- Fasting period before study: 16h (water ad libitum)
- Housing: Stainless steel wire mesh cages Type DK-III (Becker & Co., Castrop-Rauxel, Germany); 5 animals per cage
- Water: ad libitum
- Acclimation period: >1 week


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% preparation aqueous of carboxymethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v)
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: min. 1/day (symptoms); min 1/day (moribund/dead animals); weighing on d3, d7, d13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occurred (male/fermale)
Clinical signs:
no abnormalities (male/fermale)
Body weight:
Mean body weight gain (d13-d0):
106 g (male)
50 g (female)
Gross pathology:
no abnormalities (male/fermale)

Applicant's summary and conclusion