Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 309-855-7 | CAS number: 101316-49-8 The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F).
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 8001-58-9
- Cas Number:
- 8001-58-9
- IUPAC Name:
- 8001-58-9
- Reference substance name:
- Creosote
- EC Number:
- 232-287-5
- EC Name:
- Creosote
- IUPAC Name:
- 232-287-5
- Reference substance name:
- A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
- IUPAC Name:
- A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
- Details on test material:
- - Name of test material (as cited in study report): Creosote
Creosote WEI-Type B, containing less than 50 ppm BaP
- Substance type: organic
- Physical state: liquid
- Composition
Name CAS-No. Concentration [w%]
RUETGERS Chemicals // Biochem. Inst.Grimmer
=================================================
Naphthalene 91-20-3 5.07 5.39
Fluorene 86-73-7 3.06 3.07
Acenaphthylene 208-96-8 -- 0.09
Acenaphthene 83-32-9 4.09 4.04
Phenanthrene 85-01-8 8.95 8.56
Anthracene 120-12-7 0.45 0.38
Fluoranthene 206-44-0 3.70 3.84
Pyrene 129-00-0 2.49 2.08
Benz[a]anthracene 56-55-3 0.04 0.04
Chrysene 218-01-9 0.03 0.03
Benzo(a)pyrene 50-32-8 <10 ppm ca. 6. ppm
----------------------------------------------------------------
Total of 5 remaining EPA-PAH: --- < 20 pp
----------------------------------------------------------------
(Benzo[b]fluoranthene 205-99-2
Benzo[k]fluoranthene 207-08-9
Indeno[1,2,3-cd]pyrene 193-39-5
Dibenzo[a,h]anthracene 53-70-3
Benzo[ghi]perylene) 191-24-2
===========================================
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Thymidine-kinase(TK) competent cells --> TK-deficient cells (= mutation to allow survival)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Mouse lymphoma L5178Y cells (TK+/-), stock from ATCC/Maryland, USA (code: CRL 9518)
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomes derived from phenobarbital/ß-naphthoflavone induced rat liver (male SD rats), metabolic activity verified in separate testing for specific enzyme activity as well as in bacterial mutation assay.
- Test concentrations with justification for top dose:
- 2.5 - 100 µg/mL (details table below)
In general six, in one case five concentrations were tested, and – if necessary – adjusted in the second test series.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: + S9: benzo(a)pyrene [B(a)P] / - S9: methyl methanesulphonate [MMS]
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >20 - 75 µg/mL
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Report TABLE 18 - SUMMARY TABLE
Dose-level |
WITHOUT S9 (Treatment time: 3 hours), SOLVENT: DMSO |
||||
(mg/ml) |
%RS |
RTG |
MF° |
P |
Proportion small colony mutants |
0.00 2.50 5.00 10.0 20.0 40.0 50.0 MMS 10.0 |
100 91 91 71 76 75 37 75 |
100 79 87 90 86 54 21 44 |
58.11 72.37 56.58 55.38 65.04 113.1 69.60 296.8 |
- NS NS NS NS ** NS - |
0.32 0.53 0.47 0.44 0.42 0.50 0.46 0.48 |
Linear trend |
* |
Dose-level |
WITHOUT S9 (Treatment time: 24 hours), SOLVENT: DMSO |
||||
(mg/ml) |
%RS |
RTG |
MF° |
P |
Proportion small colony mutants |
0.00 6.25 12.5 25.0 50.0 75.0 100 MMS 5.00 |
100 83 71 86 61 39 0 48 |
100 99 91 101 64 33 · 54 |
55.05 54.14 72.63 74.30 80.52 75.86 · 444.2 |
- NS - |
0.25 0.17 0.21 0.26 0.28 0.26 · 0.23 |
Linear trend |
* |
Report TABLE 19 - SUMMARY TABLE
Dose-level |
WITH S9 (Treatment time: 3 hours), SOLVENT: DMSO |
||||
(mg/ml) |
%RS |
RTG |
MF° |
P |
Proportion small colony mutants |
0.00 2.50 5.00 10.0 20.0 30.0 40.0 B(a)P 2.00 |
100 100 77 65 58 38 30 50 |
100 69 55 36 26 23 18 28 |
94.02 145.8 166.1 204.8 211.2 198.0 184.1 560.6 |
- NS ** ** ** ** ** - |
0.28 0.27 0.28 0.35 0.44 0.45 0.44 0.37 |
Linear trend |
*** |
Dose-level |
WITH S9 (Treatment time: 3 hours), SOLVENT: DMSO |
||||
(mg/ml) |
%RS |
RTG |
MF° |
P |
Proportion small colony mutants |
0.00 8.89 13.3 20.0 30.0 40.0 B(a)P 2.00 |
100 58 51 31 26 32 43 |
100 53 39 22 17 30 35 |
63.59 121.2 146.7 216.9 254.7 167.2 519.6 |
- ** ** ** ** ** - |
0.16 0.27 0.25 0.38 0.35 0.33 0.36 |
Linear trend |
*** |
° = Figures displayed are mutation frequencies per million surviving cells
· = Insufficient viable cells recovered after treatment incubation period
NS = Not statistically significant
* = Statistically significant at P<5%
** = Statistically significant at P<1%
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation - Executive summary:
A creosote containing less than 50 ppm BaP was tested according to standard guidelines OECD 476 (1997). The established microtiter method was applied. An exposure time was chosen of 3 and 24 h in the absence and 2x 3 h in the presence of a metabolic system. Cytotoxicity and solubility were examined in preliminary experiments. Two independent main test series were conducted, each in duplicate for each test concentration. In general six, in one case five concentrations were tested, and – if necessary – adjusted in the second test series. The highest concentrations exhibited moderate cytotoxicity. Based on 100-% mortality of cells at 100 µg/mL, 50 to 75 µg/mL were the highest possible concentrations for testing. Creosote <50 ppm BaP showed a weak positive mutagenic activity in the presence of metabolic activation.
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.