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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:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
One dose of 15000 mg/kg bw has been administrated oraly to female rats
GLP compliance:
not specified
Limit test:
yes

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: 95-109 g (average : 103g)
- 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:
unchanged (no vehicle)
Doses:
15000 mg/kg bw
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

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
No rat died during the experiment
Clinical signs:
After the treatment the rats were in prone position and had a shaggy coat.

Any other information on results incl. tables

The authors consider the product relatively harmless after one administration of 15000 mg/kg bw

Applicant's summary and conclusion