Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.025 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
25.63 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation needed
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
sub-chronic (3 months) to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
AF not applicable when setting an inhalation DNEL based on an inhalation animal study
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
By inhalation
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral and inhalatory NOAEL(C) are available; the lowest starting point after route-to route extrapolation was obtained through the oral-to-dermal extrapolation
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
sub-chronic (3 months) to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
17.6 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
LOAEL as the starting dose
AF for interspecies differences (allometric scaling):
1
Justification:
included in the AF for other interspecies differences
AF for other interspecies differences:
10
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
skin sensitization specific AF ( 3 for differences in vehicle, 1 for differences in exposure conditions)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The major route of exposure for workers is considered to be via inhalation. An inhalatory DNEL long term for systemic effects of 1.025 mg/m3 was calculated. Peak exposure via inhalation are possible, however no acute hazard was identified after inhalation of PCBTF, therefore no acute DNEL was calculated.

Dermal exposure is also possible, leading to systemic and local effects. A systemic long-term DNEL was calculated for workers based on oral-to-dermal extrapolation and resulted to be 0.4 mg/kg bw/day. The local acute DNEL was 17.6 µg/cm² based on skin sensitization, which was the most senstive endpoint. Dermal exposure of workers can be easily controlled by the use of appropriate PPEs.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.255 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
12.75 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation needed
AF for dose response relationship:
1
Justification:
NOAEC is the starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling is applied for derivation of inhalatory DNEL
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
By inhalation
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:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral and inhalatory NOAEL(C) are available; the lowest starting point after route-to route extrapolation was obtained through the oral-todermal extrapolation
AF for dose response relationship:
1
Justification:
NOAEC is the starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.8 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
900
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
LOAEL as the starting dose
AF for interspecies differences (allometric scaling):
1
Justification:
included in the AF for other interspecies differences
AF for other interspecies differences:
10
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
skin sensitization specific AF ( 3 for differences in vehicle, 1 for differences in exposure conditions)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route -to-route extrapolatio necessary
AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The major route of exposure for the general population is considered to be via inhalation as PCBTF is persistent and volatile. An inhalatory DNEL long term for systemic effects of 0.255 mg/m3 was calculated. No peak exposure via inhalation is possible and no acute hazard was identified after inhalation of PCBTF, therefore no acute DNEL was calculated.

A systemic long-term DNEL was calculated for the dermal exposure based on oral-to-dermal extrapolation and resulted to be 0.2 mg/kg bw/day. The local acute DNEL for dermal exposure was 8.8 µg/cm² based on skin sensitization, which was the most senstive endpoint. The systemic long term oral DNEL was calculated to be 0.2 m/kg bw/d. However neither dermal nor oral exposure for the general population are expected.