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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- subchronic and chronic
- Type of information:
- experimental study
- Remarks:
- Review and evaluation of experimental data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed data, evaluation of current databases for deriving permissible exposure levels
Data source
Referenceopen allclose all
- Reference Type:
- other: Expertise, assessment report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- RIVM project 711701 "Risk in relation to Soil Quality", RIVM Bilthoven/NL; the project has the aim to derive Maximum Permissible Risk levels (MPR) for the oral route and in isolated cases for inhalation based on available data. The evaluation comprises besides others chemical classes PAH including phenanthrene. The MPR(human) is defined as the amount of a substance (usually a chemical substance) that any human individual can be exposed to daily during lifetime without significant health risk..... For genotoxic carcinogens the MPR has been defined as the excess lifetime cancer risk of 1 in 10000 (1:10E4) (RIVM 2001 (Ref. 1), Chap. 2, p. 9). For substances causing threshold effects, MPRs are expressed as Tolerable Daily Intake (TDI) or Tolerable Concentration in Air (TCA) [see Results]. For background information on MPR see Janssen and Speijers 1997 (Ref. 2).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phenanthrene
- EC Number:
- 201-581-5
- EC Name:
- Phenanthrene
- Cas Number:
- 85-01-8
- Molecular formula:
- C14H10
- IUPAC Name:
- phenanthrene
- Test material form:
- solid
- Remarks:
- as neat substance
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): phenanthrene; generic substance as evaluated in the report Ref. 1.
Test animals
- Species:
- other: mouse and rat
- Strain:
- other: various
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- other: oral and inhalation
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- not applicable
- No. of animals per sex per dose:
- not applicable
- Details on study design:
- not applicable
- Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- not applicable
- Sacrifice and pathology:
- not applicable
- Other examinations:
- Evaluation of databases (see "Any other information..")
Results and discussion
Results of examinations
- Details on results:
- not applicable
Effect levels
open allclose all
- Key result
- Dose descriptor:
- other: TDI (Tolerable Daily Intake)
- Effect level:
- 0.04 other: mg/kg bw/day (lifelong for any human)
- Based on:
- other: evaluation of toxicity database of petroleum products
- Sex:
- male/female
- Basis for effect level:
- other: non-neoplastic effects, derived as mean/representative for the aromatic >EC9 to EC 21 fraction of TPH (total petroleum hydrocarbons)
- Remarks on result:
- other: amount of a substance that any human individual can be exposed to daily during lifetime without significant health risk
- Key result
- Dose descriptor:
- other: TCA (Tolerable Concentration in Air)
- Effect level:
- 0.14 other: mg/m³ (lifelong for any human)
- Based on:
- other: evaluation of toxicity database of petroleum products
- Sex:
- male/female
- Basis for effect level:
- other: non-neoplastic effects; value is derived from the oral TDI above, assuming an absorption rate of 100 % in either case: TCA = (TDI x 70 kg/bw) / (20 m³/d)
- Remarks on result:
- other: concentration of a substance in air that any human individual can be exposed to daily during lifetime without significant health risk
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- for aromatic >EC9 to EC 21 fraction from TPH
- Effect level:
- 120 other: mg/kg bw/day, mean for the TPH fraction
- Based on:
- other: evaluation of toxicity database of petroleum products
- Sex:
- male/female
- Basis for effect level:
- other: non-neoplastic effects, derived from TDI value by application of the correction factor (3000) used for RfD derivation (mean/representative for the aromatic >EC9 to EC 21 fraction of TPH)
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Any other information on results incl. tables
For methodology see above under ‘Any other information on materials and methods incl. tables’.
In the aromatic >EC9 to EC16 fraction, relevant for phenanthrene, 77 compounds have been identified: RfDs have been developed for 8 of these (all with ECs > 9), ranging from 0.03 to 0.3 mg/kg bw/day. There are also data available on a mixture within this range: naphthalene/methylnaphthalenes: for this mixture, a RfD of 0.03 mg/kg bw/day was developed. After reviewing the information, a fraction-specific RfD of 0.04 mg/kg bw/day was considered to be appropriate (based on the 8 individual RfDs, 4 of which were 0.04 mg/kg bw/day and considering the range of the remaining RfDs). The constituent pyrene is characteristic for the >EC16 to EC21 fraction. For this substance, a RfD of 0.03 mg/kg bw/day is available. As the RfD values are very similar, the fractions considered can be combined to an >EC9 to EC21 fraction. Taking into account the combined evidence, a fraction specific RfD of 0.04 mg/kg bw/day can be adopted for the combined fraction. This fraction specific RfD value is adopted for phenanthrene as constituent contained in this fraction.
For the RfD estimation of substances present in the fraction, uncertainty factors of 3000 have be used reflecting 10 each for intra- and interspecies variability, 10 for the use of sub-chronic studies for chronic RfD derivation, and an additional 3 for quality rating of the database. Thus, the RfD estimates can be considered to be quite conservative. RfDs and the experimental database for different PAH can be extracted from the US EPA IRIS data system (URL: https://cfpub.epa.gov/ncea/iris/search/index.cfm).
The fraction-specific RfD developed using the TPHCWG approach has been uses by RIVM as Maximum Permissible Risk (MPR) level. For threshold effects, the MPR is expressed as Tolerable Daily Intake (TDI, oral route).
Reliable RfCs for inhalation have not been identified. Therefore, oral TDI values are converted to tolerable concentrations in air (TCD values) covering inhalation exposure. TCA values can be derived from TDI values taking into account the body weight, the daily respiratory volume, and different absorption rates for oral and inhalation exposure using the following equation: TCF = (TDI x 70 kg x 100) / (20 m³ x 75). But assuming equal absorption rates for either route (more conservative approach), the equation reduces to TCA = TDI x 70 kg / 20 m³.
Applicant's summary and conclusion
- Conclusions:
- For phenanthrene a TDI value of 40 µg/kg bw/day was established by evaluation of the oral repeated dose toxicity of an aromatic fraction of Total Petroleum Hydrocarbons (TPH). This fraction (ES>9 to 21) includes PAH from naphthalene to pyrene. A group TDI considered valid for PAH components in this mixture was developed by comparison of individual components of the mixture and selecting a most appropriate value for the total mixture.
The value derived is adopted for phenanthrene.
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