Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, 7 day observation period instead of 14
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Anthranilsaeureamid

Test animals

Species:
rat
Strain:
other: Gassner rats
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- The test concentration used was 20% (w/v) in aqueous suspension with CMC.
Doses:
1000, 1250, 1600, 2000, 2500, 3200 and 4000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 200 mg/kg bw
Based on:
test mat.
Mortality:
- 1000 mg/kg bw:: No mortality occured
- 1250 mg/kg bw.: 1 male animal died within 24 h. No aditional mortality occured.
- 1600 mg/kg bw:: 1 female animal died within 24 h. No aditional mortality occured.
- 2000 mg/kg bw:: 2 male and 1 female animals died within 24 h. No aditional mortality occured.
- 2500 mg/kg bw:: 8 male and 7 female animals died within 24 h. One aditional female animal died within 48 h.
- 3200 mg/kg bw:: All male (10) and 8 female animals died within 24 h. One aditional female animal died within 7 days.
- 4000 mg/kg bw: All male (10) and all female (10) animals died within 24 h.
Clinical signs:
Dyspnea, apathy, and lying in the abdominal and lateral position was observed.
Gross pathology:
Acute dilatation of the heart and congestive hyperemia of lung and liver was observed.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information