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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: other: MODIFIED AMES ASSAY
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: REILIABLE SUMMARY REPORT
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON HEAVY FUEL OILS
Author:
AMERICAN PETROLEUM INSTITUTE
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON HEAVY FUEL OILS PG 70-71

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
other: MODIFIED AMES ASSAY

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
S. typhimurium TA 98
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
1000, 5000, 10,000, 25,000 and 50,000 g/plate.
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Any other information on results incl. tables

The detailed results are provided in the report but only the summarized result for API 81-15 (cas64741-62-4) is shown below.

Maximum-fold increases in TA98 revertants/plate

10% S-9 mix                     80% S-9 mix

Trial 1    Trial 2                     Trial 1 Trial 2

13.1       27.8                      44.0 46.3

In trial 2, the sample was tested over a lower dose range (33-3333 g/plate) in order to demonstrate a dose response. Although the study was conducted to determine the effect of altering the S- 9 concentration on the assay outcome, it also clearly demonstrated that API 81-15 was mutagenic in both the standard and modified Ames assays.

Applicant's summary and conclusion