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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD Guideline 473. Study in Japanese without complete English translation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

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:
Study performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Guideline No. 473
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Lot/batch No.: CAF5267
Purity: 99.8 %

Method

Species / strain
Species / strain / cell type:
other: Chinese hamster lung cells (CHL/IU)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from rat liver (induction with phenobarbital and 5,6-benzoflavone)
Test concentrations with justification for top dose:
-S9 mix (continuous treatment): 0, 0.0038, 0.0075 and 0.015 mg/mL
-S9 mix (short-term treatment): 0, 0.0019, 0.0038 and 0.0075 mg/mL
+S9 mix (short-term treatment): 0, 0.03, 0.06 and 0.12 mg/mL
Vehicle / solvent:
Acetone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Acetone
Positive controls:
yes
Remarks:
see below
Positive control substance:
other: see below
Details on test system and experimental conditions:
Positive controls:
-S9 mix: Mitomycin C
+S9 mix: Cyclophosphamide

Continuous treatment: 24 and 48 hrs
Short-term treatment: 6 hrs
2 plates/test
Evaluation criteria:
according to OECD Guideline No. 473
Statistics:
Yes

Results and discussion

Test results
Species / strain:
other: Chinese hamster lung cells (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
See Additional information on results
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Cytotoxicity:
Short-term treatment: >= 0.015 mg/mL
Continuous treatment: >= 0.03 mg/mL

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The TS caused no chromosomal aberrations or polyploidy in Chinese hamster lung cells (CHL/IU), with or without an exogenous metabolic activation system.
Executive summary:

The TS was tested in an in vitro mammalian chromosome aberration test with Chinese hamster lung cells (CHL/IU) according to OECD Guideline No. 473.

The test concentrations were as follows:

-S9 mix (continuous treatment; 24 or 48 hrs): 0, 0.0038, 0.0075 and 0.015 mg/mL

-S9 mix (short-term treatment; 6 hrs): 0, 0.0019, 0.0038 and 0.0075 mg/mL

+S9 mix (short-term treatment; 6 hrs): 0, 0.03, 0.06 and 0.12 mg/mL.

The TS caused no chromosomal aberrations or polyploidy in Chinese hamster lung cells (CHL/IU), with or without an exogenous metabolic activation system.