Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Richtlinie 84/449/EWG, test protocol corresponds to OECD 401, Limit Test
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann, Borchen, Germany
- Acclimation period: at least 5 days
- Age at study initiation: males appr. 7-8 weeks, females appr. 9-10 weeks
- Fasting period before treatment: 16 hours
- Fasting period after treatment: 4 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Volume of application: 10 ml/kg bw

The test substance was
Doses:
2000 mg/kg bw
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: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
limit test, no statistics required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: clinical signs: temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
Mortality:
none; one male died immediately after dosing as a consequence of misapplication of the test substance
Clinical signs:
temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
Body weight:
not influenced by treatment
Gross pathology:
no unusual lesions were noted; yellowish liquid was observed in the male which was died by misapplication

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical signs temporarily increased salivation and breathing sounds were observed which disappeared up to day 3 after treatment.