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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 December 2001 to 25 Februar 2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chinese Hamster Ovary (CHO) cells

Method

Test concentrations with justification for top dose:
Concentration range in the main test (ug/ml)
With metabolic activation: Lower Upper Without metabolic activation: Lower Upper
60 480 60 480
30 400 30 400
Vehicle:
DMSO

Results and discussion

Any other information on results incl. tables

Concentration producing toxicity

a) In a preliminary test - with metabolic activation: > 471.25 ug/ml

                    - Without metabolic activation: > 471.25 ug/ml

b) In the main test - with metabolic activation: > 320 ug/ml

- Without metabolic activation: > 240 ug/ml

Applicant's summary and conclusion

Conclusions:
Haloester is not mutagenic