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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment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.