Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 292-607-4 | CAS number: 90640-86-1 Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
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:
- 03 Aug. - 06 Sep. 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Distillates (coal tar), heavy oils
- EC Number:
- 292-607-4
- EC Name:
- Distillates (coal tar), heavy oils
- Cas Number:
- 90640-86-1
- Molecular formula:
- not applicable
- IUPAC Name:
- fluoranthene; phenanthrene; pyrene
- Details on test material:
- - Name of test material (as cited in study report): anthracene oil (> 50 ppm BaP)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Microsomal fraction prepared from induced livers of male Wistar rats, induced with phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw) orally (3x)
- Test concentrations with justification for top dose:
- 1st experiment: 3.16, 10, 31.6, 100, 316, 1000, 2500, and 5000 µg/plate (TA 98, TA 100, +/-S9)
1.0, 3.16, 10, 31.6, 100, 316, and 1000 µg/plate (TA 1535, TA 1537, - S9)
10, 31.6, 100, 316, 1000 and 2500 µg/plate (TA 1535, TA 1537, + S9)
3.16, 10, 31.6, 100, 316, and 1000 µg/plate (TA 102, +/-S9)
2nd experiment: with variations based on results of 1st experiment (Report, p. 11)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: compatible with survival of bacteria and S9 activity
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see Report p. 15
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth/colony formation
- Evaluation criteria:
- Considered as mutagenic
- if a clear and dose-related increase in the number of revertants occurs in at least one tester with or without metabolic activation
and/or
- if a biologically relevant positive response for at least one of the dose groups occurs in at least one tester with or without metabolic activation.
An increase is considered relevant
- if in TA 100 and TA 102 mutation rate is at least twice as high as the rate of the solvent control;
- if in TA 98, TA 1535, and TA 1537 the mutation rate is at least 3x higher than that of the solvent control.
- Statistics:
- According to the OECD guidelines, the biological relevance is the criterion for the interpretation of the results: a statistical evaluation was not considered necessary under this premise (report p. 21).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >= 31.6 µg/pl. (-S9); at >= 316 µg/pl. (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- reproducible in both tests
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- not or weakly cytotoxic in the mutagenic concentration range
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 102
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- weak positive effect, not reproducible
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- not in the relevant mutagenic concentration range
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- dose response positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- not cytotoxic in the relevant concentration range
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Summary:
The positive effects noted without S9 were weak and not reproducible in either experiment (see below).
In the presence of S9 clear dose-related increases in the mutation rates were found in TA 98 and 1537 and a weak positive correlation in TA 100 and TA 102, reproducible at non-cytotoxic concentrations in both experiments. The most responsive tester strain was TA 98.
[Mutation factors (+S9) = 3 - 14x above background with maximum in TA 98]
In either experiment, no biological relevant increases in the mutation rate were seen in TA 1535.
Experiment I:
No relevant increases in TA 98, TA 100, TA 1537, and TA 102 (-S9);
relevant increases in TA 98, TA 100, and TA 1537 (>= 10 µg/plate, +S9)
Experiment II:
Relevant increases in TA 98 (>= 15 µg/plate, -S9);
relevant increases in TA 98, TA 100, TA 1537, and TA 102 (>= 5 - 500 µg/plate, +S9)
Dose-response relationship of the reversion rate was observed with each tester strain.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
