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Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Reason / purpose:
reference to same study
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
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
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).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 263 mg/kg bw
Based on:
test mat.
95% CL:
>= 234 - <= 295
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
236 mg/kg bw
Quality of whole database:
There are no details on the method available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute toxicity of quinidine was tested on rats via oral route. From the study it is shown, that the LD50 is 236 mg/kg bw. It is considered as toxic if swallowed according to EU criteria.

Justification for classification or non-classification

The LD50 of quinidine for rats after oral application is 236 mg/kg bw. According to CLP 1272/2008 criteria for oral application, LD50 > 50 mg/kg bw and < 300 mg/kg bw, quinidine is considered as toxic if swallowed and has to be classified in category 3.