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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: Well reported study but with some restrictions, no information about acclimatisation and housing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breed
- Weight at study initiation: 80-100 g (average : 89g)
- Fasting period before study: 16h
- Housing: plastic cages with wood shavings
- Diet (e.g. ad libitum): ALTROMIN 1324 der Firma Altrogge in Lage/Lippe ad libitum
- Water (e.g. ad libitum): tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesam oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
Doses:
1250, 1600, 2000, 2500, 3200, 5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes but only macroscopic
Statistics:
The LC50 were calculated by Probitanalyse and the confidence limits with Cavalli-Sforza.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 860 mg/kg bw
95% CL:
1 683 - 2 056
Mortality:
Before dying the rats had equilibration problems and died in prone position.
Clinical signs:
Irritation of the stomach and intestinal mucosa

Applicant's summary and conclusion