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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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
in vitro mammalian cell transformation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Chinese hamster ovary cells
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/ml
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/ml
Vehicle:
DMSO (dimethylsulfoxide)
Details on test system and conditions:
Fixation time:
24 hours. In one experiment, cells were treated continuously
without S9 for 46 hours and harvested at 48 hours.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
5000 µg/ml
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Additional information on results:
Observations:
No toxicity was observed, although precipitation above 250
micrograms per plate without S9 made evaluation impossible.


No increase in the frequency of aberrant metaphase was
observed.

Applicant's summary and conclusion

Conclusions:
The test substance was negative with and without metabolic activiation. There was no evidence that the substance induced chromosomal aberrations in the presence or absence of S9 mix.
The visible precipitation at higher concentrations may be a result of titanium dioxide forming during abiotic degradation