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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:
8.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
221.76 mg/m³
Explanation for the modification of the dose descriptor starting point:

An OECD 408 compliant 90 -day study in rat via oral route with BPA-2PO resulted to aNOAEL of 180 mg/kg/day. The corrected 8 hr inhalation NOAEC for workers is NOAEL (180) * 1.76 *0.5 *1.4 mg/m3 = 221.76 mg/m3.

- 0.5 or ½: factor 2 for route extrapolation from oral to inhalation is applied However, it is worthy to note that due to very low vp (<0.0015 Pa), exposure is only possible as aerosol.

If any exposure via inhalation does occur, this can only be in the form of larger droplets, as the use does not include fine spraying or mists.

Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal differences in absorption compared to oral route. Thus, apply a factor 2 is a very conservatism approach.

- 1.4 : correction for differences between human and experimental exposure condition (workers)

- 1.76 : correction for differences in respiratory volume (workers) 

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL and the highest dose-level tested.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
5
Justification:
Assessment factor of 5 for workers recommended by Reach guidance.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
no additional factors.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
1.8 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
Dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL of 180 mg/kg bw/day in a sub-chronic oral toxicity study in rats. As oral and dermal absorption both are considered

to be 50%, a factor of 1 for absorption will be applied.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL and the highest dose-level tested.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies differences
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
no additionnal factor
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.56 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
78.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL of 180 mg/kg bw/day in a sub-chronic oral toxicity study in rats.

Corrected inhalatory NOAEC = 180 * (1/1.15)* (1/2) = 78.26 mg/m3 

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL and the highest dose-level tested.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences for general population
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
No additioal factor.
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:
DNEL (Derived No Effect Level)
Value:
0.9 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
Dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL of 180 mg/kg bw/day in a sub-chronic oral toxicity study in rats. As oral and dermal absorption both are considered to be 50%, a factor of 1 for absorption will be applied.
AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL and the highest dose-level tested.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences for general population
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
No additional factor
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:
0.9 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
Dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL of 180 mg/kg bw/day in a sub-chronic oral toxicity study in rats.
AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL and the highest dose-level tested.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences for general population
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
No additional factor.
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