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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.56 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
Route specific data (inhalation) is not available for the test substance therefore the dose descriptor starting point is from a 28-Day repeat dose oral toxicity study.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
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:
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:
3 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
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route specific data (long term dermal exposure) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
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:
medium hazard (no threshold derived)
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 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
Modified dose descriptor starting point:
NOAEC
Value:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:
Route specific data (inhalation) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
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:
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:
1.5 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
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route specific data (long term dermal exposure) is not available for the test substance therefore the dose descriptor starting point is based on a 28-Day repeat dose oral toxicity study.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day2*4*2.5*10
AF for interspecies differences (allometric scaling):
4
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:
medium hazard (no threshold derived)
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation required
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
AF based on a 90-Day repeat dose study (sub-chronic) which gave a NOAEL >300 mg/kg bw/day. However the dose descriptor starting point is based on a 28-Day repeat dose oral study (sub-acute) which gave a NOAEL of 300mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
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:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

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