Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (BASF study).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981 version of guideline
Deviations:
no
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): Pluriol Q
- Physical state: aqueous solution
- Analytical purity: not reported
- Expiration date of the lot/batch: March 1984

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: 12 weeks
- Weight at study initiation: males: 171 g, females: 177 g (mean)
- Fasting period before study: 16 hours
- Housing: 5/cage
- Diet: fasting period before application
- Water: ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50, 38.3, 26.1 %
- Purity: aqua dest.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2610, 3830, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: several times on application day, at least once daily otherwise; moribund and dead animals: at least once daily; body weight: initially and on day 4, 7, and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
According to Finney DJ, "Probit analysis", Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 890 mg/kg bw

Any other information on results incl. tables

Clinical signs:

Males:

Symptom  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Dyspnea  15 min - 1 h  30 min - 5 h  1 h - 4 h
 Apathy  15 min - 1 h  30 min - 5 h  
 Aberrant body position  1 h  1 h  
Staggering  30 min - 1 h  30 min - 1 h  
 Tremble  30 min - 1 h  1 h  
 Twitch  1 h    
 Spastic gait  30 min  30 min - 1 d  
 Scrubby fur  30 min - 1 h  1 h  
 Diarrhea  30 min - 1 h  1 h - 1 d  
 Exophthalmus  30 min  1 h  
 Bad general condition  30 min - 1 h  30 min - 5 h  

Females:

Symptoms  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Dyspnea  15 min - 30 min  30 min  30 min - 1 d
Apathy  15 min - 30 min  30 min  30 min - 1 d
 Aberrant body position  30 min  30 min  
 Staggering    30 min  30 min - 5 h
 Atony    30 min  
 Absent pain reflex    30 min  
 Narcosis-like condition    30 min  
 Tremble  30 min  30 min  30 min - 1 h
 Twitch  30 min  30 min  
 Spastic gait    30 min  30 min - 1 d
 Scrubby fur 30 min   30 min  1 h - 1 d
 Diarrhea  30 min  30 min  30 min - 1 d
 Exsiccosis    30 min  
 Exophthalmus  30 min    30 min - 1 h
 Bloody exsudate from nose      4 h - 5 h
 Bad general condition  30 min  30 min  30 min - 1 d

Mortality:

Males:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 1 h  3/5  1/5  0/5
 1 d  5/5  3/5  0/5
 2 d  5/5  3/5  0/5
 7 d  5/5  3/5  0/5
 14 d  5/5  3/5  0/5

Females:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 1 h  5/5  5/5  0/5
 1 d  5/5  5/5  1/5
 2 d  5/5  5/5  1/5
 7 d  5/5  5/5  1/5
 14 d  5/5  5/5  1/5

Mean body weight (g):

Males:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Initially  180  167  165
 4 d  -  209  180
 7 d  -  230  221
 13 d  -  267  266

Females:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Initially  171  178  182
 4 d  -  -  205
 7 d  -  -  217
 14 d  -  -  233

Pathology:

Deceased animals:

Profound diarrhea.

Sacrificed animals:

Organs without clinical findings.

Applicant's summary and conclusion