Registration Dossier

Administrative data

Endpoint:
chronic toxicity: oral
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:
2001
Report Date:
2001
Reference Type:
study report
Title:
Unnamed
Year:
1997
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
Name:
Unnamed
Type:
Constituent
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


Test animals

Species:
other: rat and mouse
Sex:
male/female
Details on test animals 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:
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Results and discussion

Results of examinations

Details on results:
not applicable

Effect levels

open allclose all
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
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)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

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Applicant's summary and conclusion