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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Role of lime in the generation of reactive oxygen species from betel-quid ingredients
Author:
Nair, U.J., Obe, G., Friesen, M., Goldberg, M.T., Bartsch, H.
Year:
1992
Bibliographic source:
Environ Health Perspect 98: 203–205
Reference Type:
secondary source
Title:
Calciumhydroxid [MAK Value Documentation in German language, 2013]
Author:
MAK commission
Year:
2013
Bibliographic source:
The MAK Collection for Occupational Health and Safety. 1–12

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
In Syrian golden hamsters the cheek pouches were painted daily for 5 days in 5 animals with 50 μl of a 4% lime solution.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
lime solution
IUPAC Name:
lime solution
Constituent 2
Chemical structure
Reference substance name:
Calcium oxide
EC Number:
215-138-9
EC Name:
Calcium oxide
Cas Number:
1305-78-8
Molecular formula:
CaO
IUPAC Name:
oxocalcium

Test animals

Species:
hamster, Syrian

Administration / exposure

Route of administration:
dermal
Duration of treatment / exposure:
5 d
Frequency of treatment:
daily
Doses / concentrations
Dose / conc.:
50 other: µl of a 4% Lime solution
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
not examined

Any other information on results incl. tables

No increase was observed in micronucleated cells in the cheek pouches when compared to a similar number of controls

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
In Syrian golden hamsters the cheek pouches were painted daily for 5 days in 5 animals with 50 μl of a 4% lime solution.No increase was observed in micronucleated cells in the cheek pouches when compared to a similar number of controls
Executive summary:

In a mammalian cell micronucleus test, the cheek pouches of 5 Syrian golden hamsters were dermally exposed daily for 5 days with 50 μl of a 4% lime solution.

There was no evidence for an increase in micronucleated cells in the cheek pouches when compared to a similar number of controls.