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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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 for cross-reference:
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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
other: MODIFIED AMES ASSAY

Test material

Constituent 1
Reference substance name:
Clarified oils (petroleum), catalytic cracked
EC Number:
265-064-6
EC Name:
Clarified oils (petroleum), catalytic cracked
Cas Number:
64741-62-4
IUPAC Name:
64741-62-4

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type 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
Untreated negative controls:
not specified
Negative solvent / vehicle 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 / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
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