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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Test material form:
other: aqueous solution

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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:
other: 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 a
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