Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
April 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
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: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU
- Age at study initiation: 9-10 weeks
- Mean weight at study initiation: 144-173 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
- Application volume: 5 mL/kg bw

- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose. The substance is tested using a stepwise procedure, each step using three animals of a single sex (normally females). Because of the late time of dath the dose 2000 mg/kg bw was given to two groups of 3 rats.
Doses:
2000 mg/kg, 300 mg/kg bw
No. of animals per sex per dose:
6 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
Statistics:
none

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
500 mg/kg bw
Based on:
test mat.
Mortality:
The dose of 2000 mg/kg bw was lethal. All 6 treated females died at days 3 to 5 after administration. In the 300 mg/kg bw group (6 females) one animal died on day 5.
Clinical signs:
The only clinical sign observed in all animals was diarrhea.
Body weight:
Body weight and body weight development of the surviving females in the 300 mg/kg bw group was not affected.
Gross pathology:
In the animals of the 2000 mg/kg bw group that died during the observation period the only observation at gross pathology was autolysis. The one animal of the 300 mg/kg bw group that died during the observation period showed a slightly collapsed lung. The necropsies performed at the end of the observation period showed no treatment-related findings.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

The acute oral toxicity of the test material was moderate with an LD50 cut-off value of 500 mg/kg bw in rats according to OECD TG 423 (2001). All females died after oral ingestion of 2000 mg/kg bw. As clinical signs only diarrhea occurred. Besides autolysis no treatment-related findings were observed at gross-pathology in the high-dosed animals. Only one of the six females dosed with 300 mg/kg bw did not survive. As clinical signs diarrhea became obvious for all animals. Body weight development was not affected at 300 mg/kg bw in the surviving animals.