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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The LD50 of the read across substance quinine sulphate for rats is 455.8 mg/kg bw (350.82 mg quinine/kg bw) after oral application. We conclude that cinchonine which differs in a methoxy group has a similar LD50 value. The LD50 of cinchonine after intraperitoneal injection is 152 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: There are no details on the method available.
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
There are no details on the method available.
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 455.8 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no further data
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the read across substance quinine sulphate for rats is 455.8 mg/kg bw (350.82 mg quinine/kg bw). We conclude that cinchonine which differs in a methoxy group has a similar LD50 value.
Executive summary:

The acute toxicity of the read across substance quinine sulphate was tested on rats after oral application. From the study it is shown, that the LD50 of quinine sulphate is 455.8 mg/kg bw (350.82 mg quinine/kg bw). The read across substance quinine was used to determine the acute toxicity of cinchonine since cinchonine differs only in a methoxy group. Furthermore, the LD50 values of cinchonine and quinine after intraperitoneal injection are similar so that we expect that oral toxicity should be similar, too. Therefore cinchonine is considered as harmful according to EU criteria and has to be classified in Category 4 according to CLP.

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Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
350.82 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 oral toxicity of the read across substance quinine sulphate was tested on rats. From this study it is shown, that the LD50 of quinine sulphate is 455.8 mg/kg bw (350.82 mg quinine/kg bw). The read across substance quinine was used to determine the acute toxicity of cinchonine since cinchonine differs only in a methoxy group. Furthermore, the acute toxicity of cinchonine was tested via an intraperitoneal injection into six weeks old white rats. The experimental study published by Johnson, 1984 showed that the LD50 of cinchonine is 152 mg/kg bw. The LD50 values of cinchonine and quinine after intraperitoneal injection are similar so that we expect that oral toxicity should be similar, too.

Justification for classification or non-classification

The LD50 of the read across substance quinine sulphate for rats is 455.8 mg/kg bw (350.82 mg quinine/kg bw) after oral application and the LD50 of cinchonine for rats after intraperitoneal injection is 152 mg/kg bw. According to CLP 1272/2008 criteria for oral application, LD50 > 300 mg/kg bw and < 2000 mg/kg bw, cinchonine is considered as harmful, if swallowed and has to be classified in category 4.