Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 701-305-8 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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:
- 17 Jul. - 03 Sep. 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline 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)
- Principles of method if other than guideline:
- Plate incorporation test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons
- EC Number:
- 701-305-8
- Molecular formula:
- not applicaple - UVCB
- IUPAC Name:
- Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons
- Test material form:
- solid: pellets
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other:
- Remarks:
- see report, p. 15 for details
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 microsomal fraction was 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:
- Pre-experiment: 3.16, 10, 31.6, 100, 316, 1000, 2500, and 5000 µg/plate (TA 98, TA 100: +/-S9)
1st experiment: 31.6, 100, 316, 1000, 2500, and 5000 µg/plate (all tester strains, +/-S9)
2nd experiment: 250, 500, 1000, 2000, 2500, and 5000 µg/plate (all tester strains except TA 1537, +/-S9),
in addition: 125 µg/plate only for TA 98, +S9,
20, 80, 200, 800, 2000, and 5000 µg/plate (TA 1537, +S9),
250, 500, 1000, 2000, 3500, and 5000 µg/plate (TA 1537, -S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Test item was suspended in ethanol and diluted prior to use.
- Justification for choice of solvent/vehicle: compatible with survival of bacteria and S9 activity
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide, 4-nitro-o-phenylene-diamine (4-NOPD), methyl methane sulphonate (MMS), 2-aminoanthracene (2-AA); see Report p. 15 for details
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation): Materials were mixed in test tube and poured over the surface of a minimal agar plate
- Test solution (at each dose level, solvent control, negative control, or positive control: 100 µl
- S9 mix (for testing with metabolic activation or S9 mix substitution buffer (for testing without metabolic activation): 500 µl
- Bacteria suspension: 100 µl
- Overlaying agar: 2000 µl
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
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- reproducible, dose-response relationship in both experiments with metabolic activation. Without S9, weakly positive in one test.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- reproducible
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- reproducible, dose-response relationship
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: in all tester strains at test concentrations of >= 1000 µg/plate (1st experiment);
in all tester strains except tester strain TA 1537 at test concentrations of >= 1000 µg/plate (2nd experiment)
in tester strain TA 1537 at a test concentration of >= 1000 µg/plate (2nd experiment, without metabolic activation) and
at a test concentration of >= 800 µg/plate (2nd experiment, with metabolic activation)
Any other information on results incl. tables
Maximum mutation factor: 14.3 (tester strain TA 98 with metabolic activation at a dose of 3500 µg/plate, 1st experiment)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
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.
