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EC number: 292-602-7 | CAS number: 90640-80-5 A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- other: mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Creosote
- EC Number:
- 232-287-5
- EC Name:
- Creosote
- Cas Number:
- 8001-58-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Creosote
- Test material form:
- liquid
- Details on test material:
- - Test material quality: Creosote, WEI-Type B
- Substance type: organic
- Analytical purity: not applicable (UVCB substance, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
Constituent 1
- Specific details on test material used for the study:
- - Creosote WEI-Type B (benzo[a]pyrene < 50 ppm)
- Name of test material (as cited in study report): Creosote Spéciale 14130
Test animals
- Species:
- mouse
- Strain:
- other: OF1 (IOPS Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, 69592 L´Arbresle France
- Age at study initiation: Young adults, 6 - 8 weeks of age
- Weight at study initiation: 28.4 - 34.2 g (m), 22.8 - 30.3 g (f)
- Assigned to test groups randomly: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 220 mg/mL
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw - Duration of treatment / exposure:
- see below: time points
- Frequency of treatment:
- single dose
- Post exposure period:
- Time points of sampling: 24, 48, 72 h after treatment
Doses / concentrations
- Dose / conc.:
- 2 200 other: mg/kg bw (actual dose received)
- Remarks:
- limit test
- No. of animals per sex per dose:
- 5 per time point
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Substance: cyclophosphamide
- Route of administration: i.p.
- Doses / concentrations: a single application of 100 mg/kg bw
Examinations
- Tissues and cell types examined:
- - Tissue: bone marrow
- Number of animals: all animals
- Number of cells: 1000 per animal
- Type of cells: erythrocytes in bone marrow
- Parameters: numbers and types of structural aberrations; polychromatic/normochromatic erythrocytes ratio; mitotic index - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Acute toxicity; a preliminary test with 220, 1100, 2200, and 11000 mg/kg creosote and two males and two females per group preceded the main study. No mortality but clear clinical signs of toxicity at 2200 mg/kg. One hundred per cent mortality within 3 days for all animals at the highest dose.
DETAILS OF SLIDE PREPARATION: May-Grünwald-Giemsa staining - Statistics:
- Arithmetic means, Student´s test, indicator of significance p < 0.01
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- clinical signs of toxicity
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
No significant increases of the number of polychromatic erythrocytes bearing micronuclei were observed in treated animals at any time interval. A marked decrease in the ratio of polychromatic to normochromatic erythrocytes was observed after 72-h exposure, indicating a significant cytotoxic treatment-related effect on erythrocytes formation.
The positive control substance produce significant increases in the incidence of micronucleated cells and clear depression in the cellular ratio of poly- to normochromatic erythrocytes.
Table for Micronucleus Test In Vivo (MN)
Positive control group |
Vehicle control |
Limit dose |
|
Number of cells evaluated per 10 animals (group) |
10,000 |
10,000/time point |
10,000/time point |
Sampling time (h) |
24 |
24 |
48 |
72 |
24 |
48 |
72 |
||||
Number of erythrocytes |
normochromatic |
Not specified |
|||||||||
polychromatic |
Not specified |
||||||||||
polychromatic with micronuclei |
male |
31.2 ± 4.0 |
0.4 ± 0.5 |
1.2 ± 0.8 |
0.6 ± 0.9 |
0.4 ± 0.5 |
0.4 ± 0.5 |
0.4 ± 0.5 |
|||
female |
30.6 ± 8.0 |
1.2 ± 1.1 |
0.2 ± 0.4 |
0.2 ± 0.4 |
0.2 ± 0.4 |
0.4 ± 0.9 |
0.2 ± 0.4 |
||||
Ratio of erythrocytes |
polychromatic / normochromatic |
Not specified |
|||||||||
polychromatic with micronuclei / normochromatic |
0.57 ± 0.13 |
1.03 ± 0.25 |
0.78 ± 0.23 |
1.00 ± 0.16 |
0.84 ± 0.14 |
0.71 ± 0.11 |
0.62 ± 0.07 |
Applicant's summary and conclusion
- Conclusions:
- The test material creosote spéciale 14130, WEI-Type B (benzo[a]pyrene content < 50 ppm) did not induce clastogenic/chromosomal defects in developing erythrocytes in vivo in a mammaliam erythrocyte micronucleus test according to OECD TG 474. Thus, no mutagenic potential was observed for the test substance under the conditions of this test.
- Executive summary:
Creosote spéciale WEI Type B [containing less than 50 ppm B(a)P] was tested for its capability to induce clastogenic effects in red blood cells isolated from bone marrow after three time points i.p. post-application. The study was conducted according to OECD guideline 474 (1983) EEC Directive 84/449, B.12 (1984). Based on the results of a preliminary toxicity study, a limit test at 2200 mg/kg (single dose, oral) was carried out. Following treatment with creosote, possibly clastogenic and toxic effects during development of erythroblasts into polychromatic red blood cells were examined at three time intervals after application on 10 animals each (5 m, 5 f). The ratio of polychromatic (immature) to normochromatic (mature) cells was followed as measure of cytotoxicity.
Under the conditions of in vivo testing, Creosote spéciale 14130, WEI Type B, was negative for the induction of clastogenic/chromosomal defects in developing erythrocytes in vivo, thus showing no mutagenic potential.
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