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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well performed study but only poor documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: company SOP
GLP compliance:
not specified
Test type:
fixed dose procedure
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
- Strain: Wistar TNO W 74
- Source: Winkelmann, Borchen
- Age at study initiation: approximatrely 14 weeks
- Weight at study initiation: average 169 g
- Housing: inmakrolon cages typ III with wood granulate in groups of 5 animals
- Diet: Altromin R 1324 (Altromin GmbH, Lage), . ad libitum
- Water : tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1.5 °C
- Humidity (%): 60 +- 5
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: lutrol
Doses:
5000 mg/ kg bw
administered with a constant application volume of 20 ml /kg bw suspendsed in lutrol
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 (twice daily , once on weekends) and weighing (day 1 and 14)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs,

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
Sedation, coat sparse, general condition decreased, decrease of body at one animal
Body weight:
normal development except at one animal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the substance id greater than 5000 mg/kg bw.
Executive summary:

The substance was tested for acute oral toxicity. 10 female Wistar rats received once a dose of 5000 mg/kg bw. No mortality occured but syptoms such as sedation, coat sparse and decreased general condition were observed. The development of the body weight was normal except at one animal.