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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:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The purpose of the study was to determine the estimated single dose oral LD50 of the test compound in male and female rats and the clinical signs of toxicity associated with a single oral dose.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The identity of the test material concerns the same ECnumber as the substance in section 1. The purity of the test material is not described in the report, and thus might differ from the purity of the substance in section 1.

Test animals

Species:
rat
Strain:
other: CD (SD) BR VAF/Plus
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous suspension of guar gum
Doses:
single dose: 25% suspension of test substance in vehicle
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: lethal dose
Effect level:
5 000 mg/kg bw
Based on:
not specified
Remarks on result:
other: 2 males and no females died at 5000mg/kg bw on day 10
Mortality:
One of five males died prior to clinical examinations on day 10 and a second male died shortly thereafter.
Treatment-related observations noted at necropsy of these two males included test material in the gastrointestinal tract, discoloration of the non-glandular gastric mucosa by the test material, and signs of cachexia.
Clinical signs:
Abnormal clinical signs included discolored (red) feces, diarrhea, decreased feces, dehydration, and slight to moderate weakness.
Body weight:
During the first week of the study, all males and two of five females lost weight. All remaining animals gained weight normally during the second week of the study, and all survived to scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified