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Toxicological information

Acute Toxicity: other routes

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
BASF test: Five groups of 5 rats per dose were treated intra-peritoneally with preparations of the test substance in 0.5% CMC (carboxymethyl cellulose), respectively. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean weight: male 196 g; female 165 g
Source: WIGA, Sulzfeld
Diet: Alromin-R, Altrogge
Water: ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
Application form: 2% solution in 0.5% CMC
Doses:
100, 140, 200, 250, 320 mg/kg
No. of animals per sex per dose:
5
Details on study design:
Observations:
Mortality: after 1, 24, and 48 h and 7, 14, and 21 days.
Clinical signs, pathology
Statistics:
Litchfield-Wilcoxon for LD50 calculation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
178 mg/kg bw
95% CL:
144 - 221
Mortality:
see table 1
Clinical signs:
200-320 mg/kg: Dyspnea, apathy, creeping, staggering, atony, prone-lateral position, after day 7 and 21 no findings
100-140: Dyspnea, slight apathy, after day 2 and 3 no findings
Gross pathology:
no findings

Any other information on results incl. tables

Table 1: Mortalities after treatment with test substance.

 Does (mg/kg) Number of animals   death after 1 h 24 h  48 h  7 d  14 d   21 d
 320  5 m  0/5 4/5  4/5  4/5  4/5  4/5 
   5f  0/5  5/5 5/5  5/5 5/5  5/5 
 250  5m  0/5 1/5  4/5  4/5  4/5 4/5
   5f  0/5  0/5 3/5  4/5   4/5  4/5 
 200  5m  0/5  0/5 1/5  2/5  2/5  2/5 
   5f  0/5  1/5 3/5  4/5   4/5  4/5 
 140  5m  0/5  0/5  0/5   0/5   0/5   0/5 
   5f  0/5  0/5  0/5   0/5   0/5   0/5 
 100  5m  0/5  0/5  0/5   0/5   0/5   0/5 
   5f  0/5  0/5  0/5   0/5   0/5   0/5 

Applicant's summary and conclusion