Quinidine

Acute Toxicity: oral

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: Study is not done according to OECD guideline, but it is a well documented study.

Cross-reference

Reason / purpose for cross-reference:

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 oral acute toxicity of quinidine hydrochloride was assessed in 10-14 weeks old SPF-Sprague-Dawley rats (weighing 160 to 220 g). For the studies ten animals per dose, five males and five females, were used. For the oral application the substance was solved in 1% methylcellulose. 20 ml/kg bw of the compound was administered by oral gavage. 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

Test material information

Constituent 1

Reference substance name:

Quinidine hydrochloride

IUPAC Name:

Quinidine hydrochloride

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 or test system 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:

oral: gavage

Vehicle:

other: 1 % methylcellulose

Details on oral exposure:

VEHICLE- Concentration: 1%- Amount of vehicle (if gavage): 20 ml/kg bw

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. 263 mg/kg bw

Based on:

test mat.

95% CL:

>= 234 - <= 295

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 of quinidine hydrochloride for Sprague-Dawley rats is 263 mg/kg bw after oral application.

Executive summary:

In the study published by Dietmann et al., 1977 the oral toxicity of quinidine hydrochloride was tested on Sprague-Dawley rats. From this study it is shown, that the LD50 of quinidine hydrochloride is 263 mg/kg bw. According to this, the LD50 of quinidine is 236 mg/kg bw.