Registration Dossier
Registration Dossier
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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.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: subchronic and chronic
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed data, evaluation of current database 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:
- study report
- 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 to derive Maximum Permissible Risk levels (MPR) for the oral route and in isolated cases for inhalation. 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 (1:10^4) (RIVM 2001, Chap. 2, p. 9). 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.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- aromatic TPA fraction >EC9 to EC16
- IUPAC Name:
- aromatic TPA fraction >EC9 to EC16
- Details on test material:
- Phenanthrene:
FRACTION in Anthracene oil (<50 ppm BaP): 22 - 31 % (CS No. 07, GC analysis)
PHYSICO-CHEMICAL PROPERTIES
- Vapour pressure: ~ 0.016 Pa (25 °C)
- Water solubility: ~ 1.3 mg/L (25 °C)
- log Pow: 4.5 - 4.6
Constituent 1
Test animals
- Species:
- other: rat and mouse
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- other: oral and inhalation
- Details on oral exposure:
- not applicable
- 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..")
- Statistics:
- --
Results and discussion
Results of examinations
- Details on results:
- not applicable
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- for aromatic >EC9 to EC16 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, in this case aromatic >EC9 to EC16 fraction
- Basis for effect level:
- other: TDI is derived to be 0.04 mg/kg bw/day (see below). Factor used to calculate individual TDI values from NOAEL values is 3000 (Baars et al. 2001 (RIVM), page 292). Using this factor. a mean NOAEL for the aromatic >EC9 to EC16 fraction can be estimated
- Dose descriptor:
- other: TDI (Tolerable Daily Intake)
- Effect level:
- 0.04 other: mg/kg bw/d (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 16 fraction of TPH (total petroleum hydrocarbons)
- Dose descriptor:
- other: TCA (Tolerable Concentration in Air)
- Effect level:
- 0.2 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)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
--
Applicant's summary and conclusion
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.
