Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.175 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):
75
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
88.158 mg/m³
Explanation for the modification of the dose descriptor starting point:

dose descriptor calculation =

NOAEL oral * (1/SRV) * sRV*ABS = 100*1/0.38*0.67*0.5 = 88.158 mg/m3

Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value systemic effect
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 2
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
0.588 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):
150
Dose descriptor starting point:
NOAEL
Value:
100 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
88.158 mg/m³
Explanation for the modification of the dose descriptor starting point:

dose descriptor calculation =

NOAEL oral * (1/SRV) * sRV*ABS = 100*1/0.38*0.67*0.5 = 88.157 mg/m3

Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value systemic effect
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliability 2
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

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

General Population - Hazard via dermal route

Systemic effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.666 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):
150
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliablity 2
AF for remaining uncertainties:
1
Justification:
not concerned
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