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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
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 for cross-reference:
reference to same study

Data source

Reference Type:
Mutagenicity testing of quinine with submammalian and mammalian systems.
Muenzner, R. and Renner, H.W.
Bibliographic source:
Toxicology 26(2):173-8

Materials and methods

Principles of method if other than guideline:
For the in vivo mutagenicity tests Chinese hamsters (own breeding colony) were used. Animals were kept under standardized conventional conditions (air temperature 21 +- 1°C; relative humidity 55 +- 5%; 15 air changes/h; light/dark cycle of 12 h). Control groups and test group consisted of equal numbers of male and females in the adolescent age (8-13 weeks). In all tests bone marrow cells were used.sister chromatid exchange:The sister chromatid exchange test was performed with 5-bromo-deoxyuridine tablets which were implanted in the experimental animals (weighing 30 +- 2 g) as described by Allen et al, 1977: 50 mg-tablets/animal, 26-h BrdU and 2-h colchicine (Demecolcin I mg/kg) treatment time. Four animals/group were used and 50 metaphases/animal were evaluated. A single quinine treatment was given by stomach tube as aqueous solution (vol. 0.3 ml) 2 h after BrdU implantation.micronucleus test:The micronucleus test was performed in accordance with the standard procedure proposed by Schmid et al, 1973 but only a single administration of quinine was given. Thirty hours later the bone marrow cells were flushed out; 6 animals/group were used and 1000 polychromatic erythrocytes/animal were evaluated for micronuclei.chromosome aberration test:The chromosome aberration test was carried out using the conventional technique (Schwarzacher and Wolf, 1974). Quinine administration was done in the same way as indicated in the SCE test: 24-h quinine and 2-h colchicine treatment. Six animals/group were used and 300 metaphases/animal were scored for structural aberrations.
GLP compliance:
not specified
Type of assay:
other: sister chromatid exchange test, micronucleus test, chromosome aberration test

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
Automatically generated during migration to IUCLID 6, no data available
Test material form:
other: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Quinine hydrochloride- other: obtained from Merck, Darmstadt, Germany

Test animals

hamster, Chinese
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Age at study initiation: 8-13 weeks- Weight at study initiation: 30 +- 2 gENVIRONMENTAL CONDITIONS- Temperature (°C): 21 +-1 °C- Humidity (%): 55 +- 5 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:
oral: gavage
Frequency of treatment:
A single Quinine hydrochloride treatment was given 2 h after BrdU implantation.
Doses / concentrations
Doses / Concentrations:110 mg Quinine hydrochloride / kg body weightBasis:actual ingested
No. of animals per sex per dose:
sister chromatid exchange test: 4 animals (2 male, 2 females)micronucleus test: 6 animals (3 male, 3 females)chromosome aberration test: 6 animals (3 male, 3 females)
Control animals:
Positive control(s):
alkylating agent cyclophosphamide (10 mg/kg i.p.) obtained from ASTA Pharmaceuticals, Bielefeld, F.R.G.


Tissues and cell types examined:
1000 polychromatic erythrocytes/animal were evaluated for micronuclei and 300 metaphases/animal were scored for structural aberrations. In the sister chromatid exchange 50 metaphases/animal were evaluated.

Results and discussion

Test results
no effects
Vehicle controls validity:
not applicable
Negative controls validity:
Positive controls validity:

Applicant's summary and conclusion

Interpretation of results (migrated information): negativeThe results of three cytogenetic test in Chinese hamsters were negative. Thus, quinine hydrochloride can be considered not genotoxic.
Executive summary:

The genotoxicity of quinine hydrochloride was determined with the sister chromatid exchange test, micronucleus test and chromosome aberration test. The cytogenetic tests were performed with doses up to 110 mg quinine hydrochloride/kg body weight. The results of three cytogenetic test in Chinese hamsters were negative. Quinine hydrochloride is not genotoxic.