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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is not done according to OECD guideline, but it is a well documented study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Studies on antiarrhythmic effects and toxicity of quinidine and dihydroquinidine as well as defined mixtures of both in rats.
Author:
Dietmann, K., Bartsch, W. and Gutekunst, M.
Year:
1977
Bibliographic source:
Arzneimittelforschung. 27(3):589-93

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this study the acute toxicity of quinidine hydrochloride was assessed in 10-14 weeks old SPF-Sprague-Dawley rats (weighing 160 to 220 g) via intravenous injection. For the studies ten animals per dose, five males and five females, were used. For the intravenous injection the substance was solved in up to 4 % N-methylpyrrolidon in a physiological salt solution. 5 ml/kg bw of the compound was administered. The animals were closely observed for a total of 7 observation days provided the rats did not die earlier. The LD50 with a confidence interval of 95% was calculated with the probit analysis of Finney (1962) as well as Fink and Hund (1965).
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Chinidin-Hydrochlorid/ Quinidine hydrochloride (English translation)- Analytical purity: ca. 98 %- Impurities (identity and concentrations): Dihydroquinidine = 1.2%; other alkaloids < 0.5 %, water content = 0.2%- Kontr.-Nr. 5586/75

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Strain: SPF-Sprague-Dawley rats (50% female, 50% male)- Age at study initiation: 10-14 weeks- Weight at study initiation: 160-220g

Administration / exposure

Route of administration:
intravenous
Vehicle:
other: up to 4 % N-methylpyrrolidon
Details on exposure:
VEHICLE- Concentration: up to 4%
No. of animals per sex per dose:
10 rats per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: The animals were closely observed for a total of 7 observation days provided the rats did not die earlier.
Statistics:
The LD50 with a confidence interval of 95% was calculated with the probit analysis of Finney (1962) as well as Fink and Hund (1965).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 30 mg/kg bw
Based on:
test mat.
95% CL:
>= 27 - <= 34

Applicant's summary and conclusion

Conclusions:
The LD50 of quinidine hydrochloride for Sprague-Dawley rats is 30 mg/kg bw after intravenous injection.
Executive summary:

In the study published by Dietmann et al., 1977 the acute toxicity of quinidine hydrochloride was tested on Sprague-Dawley rats via an intravenous injection. In this study, it is shown that the LD50 of quinidine hydrochloride is 30 mg/kg bw. According to this, the LD50 of quinidine is 27 mg/kg bw.