Registration Dossier
Registration Dossier
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EC number: 270-984-6 | CAS number: 68512-62-9 A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
Genetic toxicity: in vitro
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:
- 2 003
- 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
- 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
Constituent 1
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
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