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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment
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
Reference Type:
other: One-page summary of the report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
A modified procedure was used to enable testing of a gaseous chemical.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
butadiene concentrate
IUPAC Name:
butadiene concentrate
Constituent 2
Reference substance name:
68476-28-2
IUPAC Name:
68476-28-2
Details on test material:
- Name of test material (as cited in study report): butadiene concentrate (CRU #84237)
- Other: no further detail given

Method

Target gene:
not applicable
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
10, 25, 50, 75 and 100 µL/plate
Vehicle / solvent:
- Vehicle(s): no data
Controls
Negative solvent / vehicle controls:
other: air
Positive controls:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation
- No further data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
none

Any other information on results incl. tables

In the preliminary toxicity/initial mutagenicity assay, toxicity was seen in TA100 over a range of volumes from 75 -100 µL per plate with and without S9, and in TA1537 with and without S9 over a range of volumes from 100 -500 µL.

None of the 5 strains exhibited reversion frequencies substantially different from spontaneous controls in the pre-incubation assay.

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Butadiene concentrate was not a mutagen with or without metabolic activation in this test system
Executive summary:

In an Ames assay with butadiene concentrate, there was no evidence of mutagenic potential, with or without metabolic activation.