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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.65 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Derivation of a worker inhalation DNEL from a human oral TDI value (general population) for phenanthrene (see below under "Discussion")
Overall assessment factor (AF):
0.08
Modified dose descriptor starting point:
other: TCA for phenanthrene (0.14 mg/m3) is adjusted to total toxic components of anthracene oil taking into account the fraction of phenanthrene present compared to total identified substances (TCA x 0.28 / 0.75, see below under "Discussion")
Value:
0.052 mg/m³
Explanation for the modification of the dose descriptor starting point:
As starting point for a worker inhalation systemic long-term DNEL, the original (oral) TDI value (0.04 mg/kg bw/d) for phenanthrene is converted to a TCA value (tolerable concentration in air) taking into account the human standard body weight and the daily respiratory volume (general population). The TCA is calculated to 0.14 mg/m³ (0.04 x 70 / 20).
AF for dose response relationship:
1.6
Justification:
adjustment of respiration volume (AF = 1/0.67 = 1.49, rounded to 1.6 to comply with limits in decimals of the data system)
AF for differences in duration of exposure:
0.1
Justification:
adjustment from general population to workers: 24h/d, 7d/wk, 75 y versus 8h/d, 5d/wk, 40 y (AF = 1/7.88 = 0.127)
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable: Starting point relates to humans
AF for other interspecies differences:
1
Justification:
not applicable: Starting point relates to humans.
AF for intraspecies differences:
0.5
Justification:
adjustment from general population to workers: intraspecies factor (AF = 5/10 = 0.5)
AF for the quality of the whole database:
1
Justification:
no special adjustment
AF for remaining uncertainties:
1
Justification:
no special adjustment
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.65 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: adoption of systemic DNEL
Overall assessment factor (AF):
1
Dose descriptor:
other: DNEL (inhal., long-term, systemic) for anthracene oil (0.65 mg/m3)
AF for dose response relationship:
1
Justification:
included in starting point
AF for differences in duration of exposure:
1
Justification:
included in starting point
AF for interspecies differences (allometric scaling):
1
Justification:
included in starting point
AF for other interspecies differences:
1
Justification:
included in starting point
AF for intraspecies differences:
1
Justification:
included in starting point
AF for the quality of the whole database:
1
Justification:
no special adjustment
AF for remaining uncertainties:
1
Justification:
no special adjustment
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: DNEL(worker, dermal, systemic long-term) is derived from a human oral TDI value (general population) for phenanthrene (see below under "Discussion")
Overall assessment factor (AF):
0.05
Modified dose descriptor starting point:
other: The dermal TDI value for phenanthrene (0.08 mg/kg bw/d) is adjusted to total toxic components of Anthracene Oil taking into account the fraction of phenanthrene present compared to total identified substances (TDI(phenanthrene) x 0.28 / 0.75, see below).
Value:
0.03 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As starting point for a worker dermal systemic long-term DNEL, the original (oral) TDI value (0.04 mg/kg bw/d) for phenanthrene is converted to account for differences in absorption (oral vs. dermal 1 to 0.5). The dermal TDI value is calculated to 0.08 mg/kg bw/d.
AF for dose response relationship:
1
Justification:
not applicable
AF for differences in duration of exposure:
0.1
Justification:
adjustment from general population to workers: 24h/d, 7d/wk, 75 y versus 8h/d, 5d/wk, 40 y (AF = 1/7.88 = 0.127)
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable: Starting point relates to humans
AF for other interspecies differences:
1
Justification:
not applicable: Starting point relates to humans
AF for intraspecies differences:
0.5
Justification:
adjustment from general population to workers: intraspecies factor (AF = 5/10 = 0.5)
AF for the quality of the whole database:
1
Justification:
no special adjustments
AF for remaining uncertainties:
1
Justification:
no special adjustments
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Long-term effects - derivation of DNELs

Anthracene oil < 50 ppm BaP (AOL) is a UVCB and consists of a complex combination of polycyclic aromatic hydrocarbons. It comprises mainly 3-ring aromatic compounds and to a lesser extent PAHs with >=4 rings (see Chapter 1.). 2-ring aromatics are minor (<2%). Based on its composition, anthracene oil is non-carcinogenic as the amount of higher molecular weight carcinogenic PAH (i. e. BaP) is below 50 ppm. Long-term toxicity is represented by non-carcinogenic effects of the PAH contained in AOL and accordingly, DNELs are derived.

Main component of anthracene oil < 50 ppm BaP is phenanthrene. It is present in AOL in concentrations up to 31% (average 28%). Phenanthrene belongs to the PAH with the most pronounced effects resulting from non-carcinogenic repeated dose toxicity. Hence, it is justified to take phenanthrene as representative for the long-term toxic effects of other PAH present in AOL. Phenanthrene is selected as marker substance to characterise repeated dose toxicity of AOL. Long-term DNELs are derived based on long-term toxicity data for phenanthrene.

As phenanthrene is only a fraction of PAH comprising AOL, PAH other than anthracene have to be taken into account in assessing health hazards related to total AOL. As toxicity of phenanthrene is considered to be representative for other PAH contained in AOL, adjustment is carried out by simply allowing for the respective percentages. Content of phenanthrene in AOL is ca. 28%. All identifiable substances amount to ca. 75% (see Chapter 1.). A factor of 0.37 (28/75) is used to extrapolate from effects related to phenanthrene to effects which can be assigned to total AOH. In applying this factor, DNELs are derived which are valid for total AOL rather than just for phenanthrene.

Toxicological basis for derivation of DNELs is a TDI value (tolerable daily intake) for phenanthrene (0.040 mg/kg bw/d). It was established by RIVM, the Netherlands ((Baars et al. 2001; Janssen and Speijers, 1997) for the target group general population. Other PAH were also included in the evaluation. For development of TDI values/reference doses, available toxicity data from various sources were analysed (RIVM, US EPA, ATSDR, WHO/IPCS, IARC Monograph) and carcinogenic and non-carcinogenic effects were considered. The values established are based on a broad peer reviewed data base and constitute a most reliable toxicity evaluation of PAH. Inclusion of reference doses for other PAH present in AOL allows comparison of toxicity thresholds and substantiates that phenanthrene repeated dose toxicity is representative for the toxicity of the other PAH present in AOL.

In order to derive a DNEL, the TDI value for phenanthrene was adjusted. In a first step, a route to route extrapolation (oral to inhalation/dermal) was performed if required. In a second step, adaption to total AOL was carried out (extrapolation factor 0.37, see above). In following steps, assessment factors were applied considering for differences in exposure (general population to worker) and for intraspecies differences as appropriate. Experimental exposure duration and Interspecies differences were already accounted for in the preparation of the phenanthrene TDI.

References:

Baars et al. 2001, Re-evaluation of human-toxicological maximum permissible levels. RIVM report 711701 025 [http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf]

Janssen and Speijers 1997, Guidance on the derivation of Maximum Permissible Risk levels for human intake of soil. RIVM report 711701 006 [http://www.rivm.nl/bibliotheek/rapporten/711701006.pdf]

Local effects - qualitative assessment

Anthracene oil < 50 ppm BaP and EU creosote are closely structure-related products. They are produced in a similar process (fractionated distillation of coal tar using overlapping conditions). Consequently, composition of both substances is quite similar. Major components are mid-range PAH (naphthalene to pyrene). Individual differences in distillation conditions and in starting material may cause gradual variation in qualitative and quantitative composition. But the nature of constituents and the individual components coincide, and the percentage of single substances is of the same magnitude. Toxicological effects of both substances will approximately be the same. Creosote is used as supporting substance to assess qualitative health hazards identified for AOL (skin irritation, skin sensitisation)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.052 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Derivation of a DNEL(general population, inhalatation, systemic, long-term) based on an human oral TDI value (general population) for phenanthrene (see below "Discussion")
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: TCA for phenanthrene (0.14 mg/m³) is adjusted to total toxic components of anthracene oil taking into account the fraction of phenanthrene present compared to total identified substances (TCA x 0.28 / 0.75, see below under "General Discussion")
Value:
0.052 mg/m³
Explanation for the modification of the dose descriptor starting point:
As starting point for the DNEL(general population, inhalation, systemic, long-term), the original (oral) TDI value (0.04 mg/kg bw/d) for phenanthrene is converted to a TCA value (tolerable concentration in air) taking into account the human standard body weight and the daily respiratory volume (general population). The TCA is calculated to 0.14 mg/m³ (0.04 x 70 / 20).
AF for dose response relationship:
1
Justification:
included in the dose descriptor
AF for differences in duration of exposure:
1
Justification:
included in the dose descriptor
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable, human-specific
AF for other interspecies differences:
1
Justification:
not applicable, human-specific
AF for intraspecies differences:
1
Justification:
included in the dose descriptor
AF for the quality of the whole database:
1
Justification:
no special adjustment
AF for remaining uncertainties:
1
Justification:
no special adjustment
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.015 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Tolerable Daily Intake (TDI) for phenanthrene (0.04 mg/kg bw/d) is adjusted to total toxic components of AOL taking into account the fraction of phenanthrene present compared to total identified substances (TCA x 0.28 / 0.75) (see under "Discussion").
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: TDI
Value:
0.015 mg/kg bw/day
AF for dose response relationship:
1
Justification:
included in the dose descriptor
AF for differences in duration of exposure:
1
Justification:
included in the dose descriptor
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable: Starting point relates to humans
AF for other interspecies differences:
1
Justification:
not applicable: Starting point relates to humans
AF for intraspecies differences:
1
Justification:
included in the dose descriptor
AF for the quality of the whole database:
1
Justification:
no special adjustment
AF for remaining uncertainties:
1
Justification:
no special adjustment
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Long-term effects - derivation of DNELs

General population is not a target group for exposure by anthracene oil < 50 ppm BaP (AOL) as AOL is not used in consumer products. Exception is exposure of man via environment (inhalation and oral route). As consequence, DNELs(general population) are derived only for inhalation route, systemic, long-term and for oral route systemic, long-term. Other hazards have not been identified for the general population.

Toxicological basis for deduction of DNELs is the TDI value for phenanthrene established by RIVM (see above under workers). Procedure for deduction of DNELs(general population) is the same as outlined for workers except that no adaption to the target group was necessary (TDI relates to general population).

References:

Baars et al. 2001, Re-evaluation of human-toxicological maximum permissible levels. RIVM report 711701 025 [http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf]

Janssen and Speijers 1997, Guidance on the derivation of Maximum Permissible Risk levels for human intake of soil. RIVM report 711701 006 [http://www.rivm.nl/bibliotheek/rapporten/711701006.pdf]