Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.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:
no guideline followed
Principles of method if other than guideline:
According to BASF-internal standard. Five Kisslegg mice per sex per dose were intraperitoneally exposed to 800, 1000, 1250, 1600, 2000, 2500, and 3200 mg/kg of the test substance followed by a 7 day observation period. Clinical signs were recorded and macroscopic examinations were performed.
GLP compliance:
no
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:
mouse
Strain:
other: Kisslegg mice
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
The test concentration used was 16% (w/v) in aqueous suspension with CMC.
Doses:
800, 1000, 1250, 1600, 2000, 2500, 3200 mg/kg bw
No. of animals per sex per dose:
5
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 064 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (947 - 1197 mg/kg)
Sex:
male
Dose descriptor:
LD50
Effect level:
1 010 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (828 - 1233 mg/kg)
Sex:
female
Dose descriptor:
LD50
Effect level:
1 106 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (958 - 1278 mg/kg)
Mortality:
- 800 mg/kg bw: 1 female rat died within 48 hours and another male rat within 7 days
- 1000 mg/kg bw: 1 male rat died within 24 hours and another male rat died within 7 days
- 1250 mg/kg bw: 4 males and 3 females within 24 hours. In addition, 1 male rat died within 48 hours and 1 female died within 7 days.
- 1600 mg/kg: 4 males and 5 females within 24 hours.
- 2000 - 3000 mg/kg: 10/10 within 24 hours.
Clinical signs:
- 1600-3200 mg/kg bw: Immediately after injection, lying in abdominal and lateral position, rapid breathing and apathy was observed. No symptoms were observed after 4 days.
- 800-1250 mg/kg bw: Immediately after injection, staggering and 5 minutes later lying abdominal and lateral position and rapid breathing was observed. No symptoms were observed after 4 days
Gross pathology:
Congestive hyperemia of the liver was observed.

Applicant's summary and conclusion