Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phthalid

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 21.5 g (mean), females: 20.0 g (mean)


Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
681, 1000, 1470, 2150 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
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 - < 1 470 mg/kg bw
Mortality:
2150 mg/kg bw: 5/5 males and 4/5 males died within 1 h.
1470 mg/kg bw: 5/5 males and 5/5 females died within 1h.
1000 mg/kg bw: 1/5 males died within 1 h.
681 mg/kg bw: no mortalities.
Clinical signs:
Dyspnoea, apathy, abdominal-lateral position, tumbling, bad general condition.
Body weight:
Surviving animals gained normal weight.
Gross pathology:
No abnormalities observed.

Applicant's summary and conclusion