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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Dec 18, 2000 - Mar 09, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was performed for a structural similar analoge of the compound. For this analogue, a chromosomal abberration assay was conducted according to Good Laboratory Practice (GLP). The study procedures described in this report are based on the requirements of the following guidelines:- OECD Guideline for the testing of Chemicals: Genetic Toxicology: 473 In vitro mammalian chromosome aberration test.- Japanase Testing Guidelines The test material shows a high similarity in chemical descriptors and physicochemical profile (logP, water solubility) to the query compound providing a sound basis for read across for this in vitro assay.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
Principles of method if other than guideline:
none
GLP compliance:
yes (incl. certificate)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S9 after induction using Aroclor 1254
Test concentrations with justification for top dose:
0, 10.2, 20.5, 40.9, 81.9, 164, 328, 655, 1310, and 2620 µg / ml medium; Precipitation of the test material was observed at concentrations larger or equal to 81.9 µg/mL.
Vehicle / solvent:
DMSO
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
Migrated to IUCLID6: +S9
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
Migrated to IUCLID6: -S9
Details on test system and experimental conditions:
According to guideline
Evaluation criteria:
According to guideline
Statistics:
Descriptive statistics

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Precipition: >=81.9 µg/mL
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative with and without S9Treatment of V79 cell cultures with the test material, in the absence and presence of S9 mix, did not increase the proportion of cells with aberrant chromosomes. Thus, the test material was not clastogenic in this in vitro test system.
Executive summary:

Purpose

The purpose of the in vitro chromosome aberration test is to identify agents that cause structural chromosome aberrations in cultured mammalian cells thus providing information on possible health hazards for the test material and serve as a rational basis for risk assessment to the genotoxic potential of the test item in man.

Study Design

In this study the clastogenic potential of the test material was evaluated by examining its effects on the chromosomes of CHO cells, cultured in vitro and treated in the absence and presence of a rat liver metabolising system (S-9). The test methodology in this study is in accordance with current literature and complies with the OECD Guideline 473 (1997).

Results

Precipitation of the test material was observed at concentrations larger or equal to 81.9 µg/mL. The test material did not induce structural chromosome aberrations when tested at, or very close to, its limit of cytotoxicity following 24 hour treatment in the absence and presence of S9. No treatment-related increase of endoreduplications or polyploid cells was observed.

i.e. neither structural nor numerical aberrations were detected.

Conclusion

In conclusion, treatment of V79 cell cultures with the test material, did not increase the proportion of cells with aberrant chromosomes, thus the test material was not clastogenic in this in vitro test system.