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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The assay follows the principles of the guidelines, modified specifically for gaseous materials. Deviations are considered acceptable for drawing conclusions.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
An improved system for exposure of cultured mammalian cells to gaseous compounds in the chromosomal aberration assay
Asakura M, Sasaki T, Sugiyama T, Arito H, Fukushima S and Matsushima T
Bibliographic source:
Mutation Research 652, 122-130

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
System comprised 12 square culture vessels, a device for preparation of air containing test gas, and positive and negative control gases at target concentrations and for supplying these gases to the culture vessels, and a roller apparatus in an incubator. Chinese hamster lung cells (CHL/IU) were grown on one side of the inner surface of the square culture vessel in MEM medium. Immediately prior to exposure, the medium was changed to modified MEM. Air in the culture vessel was replaced with air containing test gas, positive or negative control gas. Then, the culture vessels were rotated at 1.0 rpm. The monolayered culture cells were exposed to test gas during about 3/4 rotation at upper positions and alternatively immersed into the culture medium during about 1/4 rotation at lower positions.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Reference substance name:
Details on test material:
- Name of test material (as cited in study report): 1,3-Butadiene
- Supplier: Sumitomo-Seika Chemicals Co. Ltd., Tokyo, Japan.
- Physical state: gas
- Analytical purity: >95%


Target gene:
not applicable
Species / strain
Species / strain / cell type:
mammalian cell line, other: A clonal sub-line derived from the lung of a newborn female Chinese hamster (CHL/IU)
Details on mammalian cell type (if applicable):
Type and identity of media: Cells were cultured in Eagle’s MEM supplemented with 10% heat-inactivated CS, grown in a monolayer and, for exposure, modified MEM (m-MEM containing 10% CS, NaHCO3 0.22 g/L, 1 M NaOH 1 ml/L and 10 mM HEPES
Metabolic activation:
with and without
Metabolic activation system:
A post-mitochondrial supernatant fraction of liver homogenates (S9) from the phenobarbital- and 5,6-benzoflavone-pretreated rat
Test concentrations with justification for top dose:
0 – 20% atmosphere of 1,3-butadiene for 6h
Vehicle / solvent:
Controlsopen allclose all
Positive controls:
Positive control substance:
other: Vinyl chloride and methyl chloride
+/- S9 mix
Untreated negative controls:
Details on test system and experimental conditions:
See below
Evaluation criteria:
see below

Results and discussion

Test results
Species / strain:
mammalian cell line, other: A clonal sub-line derived from the lung of a newborn female Chinese hamster (CHL/IU)
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
other: Reduction in Growth Index was measured
Untreated negative controls validity:
Positive controls validity:
Additional information on results:

Any other information on results incl. tables

The frequency of structural abberrations was increased in a dose-related manner after 6 hour exposure to gaseous 1,3-butadiene with and without metabolic activation. The frequency of structural aberrations was similar in the presence and absence of metabolic activation. 


Applicant's summary and conclusion

Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation

Exposure of (CHL/IU) cells to gaseous 1,3-butadiene for 6 hours induced structural aberrations in the presence and absence of metabolic activation.
Executive summary:

1,3 -butadiene was tested in a chromosomal aberration assay in an improved system for the exposure of cultured mammalian cells to gaseous compounds. Exposure to 1,3-butadiene for 6 hours induced a dose-related increase in structural aberrations, with and without S9 metabolic activation.