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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.87 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
881.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC= 1000 * (1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not used for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL. The predicted NOAEL value for EPO for pre-natal developmental toxicity is derived from this read-across study of ESBO (RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available developmental study. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 1000 mg/kg bw/day * (ABSoral/ABSdermal)=5000 mg/kg bw/day Dermal NOAEL=oral (NOAEL*( ABSoral/ABSdermal) Differences in absorption Abs (oral-rat) / Abs (dermal-human): 5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for EPO for pre-natal developmental toxicity is derived from this read-across study of ESBO (RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available developmental study. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
1.44 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEC
Value:
434 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEC=1000 mg/kg bw/day*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.) = 434 mg/m3 Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL. The predicted NOAEL value for EPO for pre-natal developmental toxicity is derived from this read-across study of ESBO (RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available developmental study. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.166 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 1000 mg/kg bw/day * 5 = 5000 mg/kg bw/day Differences in absorption Abs (oral-rat) / Abs (dermal-human): 5
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for EPO for pre-natal developmental toxicity is derived from this read-across study of ESBO (RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available developmental study. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.833 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No extrapolation required.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for EPO for pre-natal developmental toxicity is derived from this read-across study of ESBO (RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available developmental study. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

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