Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17 µg/m³
DNEL related information
DNEL derivation method:
other:
Dose descriptor starting point:
other: OEL
Value:
2 µg/m³
Explanation for the modification of the dose descriptor starting point:

The OEL (occupational exposure limit) values for benzo[a]pyrene have been established by the European Agency for Safety and Health. In this report the lowest OEL value for 8 hours exposure is 0.002 mg/cubic metre. Shale Oil Heavy fraction typically contains 12% of benzo[a]pyrene; therefore the inhaltion DNEL for Shale Oil Heavy fraction has been amended accordingly : 0.002 mg/cubic metre / 12% = 0.017 mg/cubic metre or 17 ug/cubic metre. See discussion for reasoning why only benzo[a]pyrene of all the components needs to be taken into account.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
67 µg/m³
DNEL related information
Dose descriptor starting point:
other: OEL
Value:
8 µg/m³
Explanation for the modification of the dose descriptor starting point:

The OEL (occupational exposure limit) values for benzo[a]pyrene have been established by the European Agency for Safety and Health. In this report the lowest OEL value for 15 minute exposure is 0.008 mg/cubic metre. Shale Oil Heavy fraction typically contains 12% of benzo[a]pyrene; therefore the inhalation DNEL for Shale Oil Heavy fraction has been amended accordingly: 0.008 mg/cubic metre / 12% = 0.067 mg/cubic metre or 67 ug/cubic metre See discussion for reasoning why only benzo[a]pyrene of all the components needs to be taken into account.

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 µg/kg bw/day
DNEL related information
DNEL derivation method:
other:
Dose descriptor starting point:
other: AEL
Value:
0.02 µg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
he AEL (acceptable exposure limit) values for benzo[a]pyrene have been established by Public Health England at 0.02 ug/kg bw/day for oral exposure. Given that Shale Oil Heavy fraction typically contains 12% of benzo[a]pyrene and assuming that dermal absorption is 100%, the dermal DNEL for Shale Oil Heavy fraction has been amended accordingly : 0.02 ug/kg bw/day / 12% = 0.17 ug/kg bw/day.ng that dermal absorption is 100%, the dermal DNEL for Shale Oil Heavy fraction has been amended according to the following: 0.02 ug/kg bw/day / 12% = 0.17 ug/kg bw/day. See discussion for reasoning why only benzo[a]pyrene of all the components needs to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 µg/kg bw/day
DNEL related information
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
The short-term DNEL for dermal exposure has been derived from the long-term DNEL according to the following: 0.17 ug/kg bw/day x 3 = 0.5 ug/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The DNELs are based on European accepted OELs (and AELs).

The OEL (occupational exposure limit) for benzo[a]pyrene was been taken from the European Agency for Safety and Health report (document attached).

The AEL (acceptable exposure limit) for benzo[a]pyrene was taken from the Public Health England report (document attached).

Even at 12%, the presence of PAH is still the only component that needs to be taken into consideration in the derivation of DNELs, because comparison of existing reference doses and exposure limits, show that for PAHs is 10,000 lower than the next lowest reference dose i.e. extrapolating the OEL for each oil fraction from the PAH content still results in a lower OEL, than if it were done based on the content of any other of the remaining components. See attached document: "Shale oil: comments on ECHA’s Draft decision".

Available data indicated that the registered substance is of low acute toxicity following oral, dermal and inhalation exposures, however, it is irritating for skin and eyes, and does seem to possess skin sensitisation potential. Complex substances identified as “Shale oils” are classified as carcinogen category 1b (CLP), based on animal studies as well as evidence in humans. Limited genotoxicity testing performed with the current substance, or with related substances, do not suggest genotoxic potential. Some limited in vivo data is available on the registered substance and related substances, however until further proposed in vivo data becomes available it is not appropriate to derive DNELs/DMELs, or propose classification. Until such a time as DMELs/DNELs become available, a qualitative assessment has been performed according to the „Guidance on information requirements and chemical safety assessment – Part E: Risk Characterisation“. On the basis of the classification of similar materials discussed in the public domain, the registered substance might notionally be considered as carcinogen category 1b (CLP), and the importance of this health effect supersedes any other classification (irritation, skin sensitisation). On this basis, the registered substance would notionally be allocated to the high hazard profile category. The manufacturing process for the substance is closed, sampling for quality control purposes is done using a valve and no exposure is expected to occur. Examining the uses of the registered substance, exposure of workers as well as of professional workers can occur only under process category 8b, i.e. during transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities. Relevant routes of exposures are the dermal and, less likely, the inhalation. In order to guarantee adequately control of risks (in the face of a potential carcinogenicity classification), it would be necessary to stipulate risk management measures and operational conditions that prevent dermal and/or inhalation exposures.

General Population - Hazard via inhalation 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
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:
no hazard identified
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

There will be no exposure to the substance of the general population.