Calcium acetylide

Genetic toxicity: in vivo

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

lime solution

IUPAC Name:

lime solution

Constituent 2

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.