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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.86 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
139.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Oral absorption rate: both oral and inhalation absorptions set at 50 % (oral absorption not expected to be lower than the inhalation absorption)

NOAEL oral * (1/SRV) * sRV*ABS = 79*(1/0.38)*(0.67)*(1) = 139.3 mg/m3

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 for conversion of oral dose to inhalation concentration, using the section R.8.4.2 of the REACh guidance document
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 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.26 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):
300
Dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Default value of oral-to- dermal extrapolation = 1 (oral and dermal absorption both set at 50%)

NOAEL oral *ABS = 79*1 = 79 mg/kg bw/d

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):
4
Justification:
factor for allometric scaling (4 for rat)
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 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
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:
0.46 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
68.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Oral absorption rate: both oral and inhalation absorptions set at 50 % (oral absorption not expected to be lower than the inhalation absorption)

NOAEL oral * (1/SRV) * ABS = 79*(1/1.15)* (1) = 68.7 mg/m3

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 for conversion of oral dose to inhalation concentration, using the section R.8.4.2 of the REACh guidance document
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 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
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:
0.13 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):
600
Dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Default value of oral-to- dermal extrapolation = 1 (oral and dermal absorption both set at 50%)

NOAEL oral *ABS = 79*1 = 79 mg/kg bw/d

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):
4
Justification:
factor for allometric scaling (4 for rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1 and 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
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:
0.13 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):
600
Dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

No route to route extrapolation applicable (oral route data)

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):
4
Justification:
factor for allometric scaling (4 for rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1 and 2 data
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

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