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: 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
Test type:
standard acute method

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 209 g (mean); females: 164 g (mean)
- Diet: Altromin R1324 (Altromin GmbH, Germany), ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 CMC aqueous solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 21.5%, 31.6%, 38.3%, 46.4%, 50%



MAXIMUM DOSE VOLUME APPLIED: 20 ml

Doses:
2150, 3160, 3830, 4640, 5620, 6810, 10000 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
- Frequency weighing: days 0, 3, 7 and 13
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 600 mg/kg bw
Mortality:
10000 mg/kg bw: all animals died within 1 h and 24 h.
6810 mg/kg bw: all animals died within 1 h and 24 h.
5680 mg/kg bw: 2/5 males and 2/5 females died within 24 h.
4640 mg/kg bw: no mortalities.
3830 mg/kg bw: 1/5 males died within 24 h.
3160 mg/kg bw: 2/5 males and 1/5 females died within 24 h.
Clinical signs:
Dyspnoea, apathy, abdominal-lateral position, partially tumbling, atony, narcotic state with unusual pain and corneal reflex, exsiccosis, salivation, bad general condition.
Body weight:
The surviving animals gained normal weight.
Gross pathology:
Animals that died during the study:
Heart: acute dilatation of the right ventricle; acute congestion;

Sacrificed animals: no macroscopic abnormalities at necropsy.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw) gender 24 h 48 h  14 days                
10000 m 5/5 5/5  5/5                
10000 f 5/5 5/5  5/5                
6810 m 5/5 5/5  5/5                
6810 f 5/5 5/5  5/5                
5680 m 2/5 2/5  2/5                
5680 f 2/5 2/5  2/5                
4640 m 0/5 0/5  0/5                
4640 f 0/5 0/5  0/5                
3830 m 1/5 1/5  1/5                
3830 f 0/5 0/5  0/5                
3160 2/5 2/5  2/5                
3160 f 1/5 1/5  1/5                
2150 m 0/5 0/5  0/5                
2150 f 0/5 0/5  0/5                

Applicant's summary and conclusion