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: GLP and Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Michigan, USA
- Weight at study initiation: 205-262 g


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no vehicle used

Doses:
0, 169, 205, 248, 300 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2.5 and 4 hours after administration and once daily thereafter
- Necropsy of survivors performed: yes
Statistics:
Dose-effects were evaluated using the method developed by Litchfield and Wilcoxon.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
207 mg/kg bw
Based on:
act. ingr.
95% CL:
197 - 216
Remarks on result:
other: Females were more sensitive than males.
Mortality:
In the 205 mg/kg bw dose group, one male and 2 females died, in the 248 mg/kg bw dose group 2 males and 5 females and in the highest dose group all animals died.
Clinical signs:
Diarrhoe was only observed once in the lowest dose group and occurred more frequently in the higher dose groups. Brown/red staining around the mouth was predominantly observed in the 248 and 300 mg/kg bw test groups, as well as respiratory rates, ataxia and lethargy. Other clinical signs reported were hypothermia, bradypnoea and ocular discharge.
Body weight:
No abnormalities were observed.
Gross pathology:
At necropsy, enlarged and reddened adrenal glands, meningeal haemorrhage, dark reddening of the cortico-medullary junctions in the kidneys, reddened and distended stomachs, reddened intestines, dark purple colouring of the livers and in one case a dark reddening of the lungs were found from the 205 mg/kg bw dose groups onwards.

Applicant's summary and conclusion