Hydrocarbons, C4, steam-cracker distillate

Genetic toxicity: in vitro

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other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment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

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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.