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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 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
Value:
42 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
33.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

In accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health" (Figure R. 8-3) the oral - inhalation (route to route) dose descriptor was calculated as follows :-

NOAEC (workers) = NOAEL x [1/0.38] x [0.5 x 1] x 0.67

= 42 x (2.63 x 0.5 x 0.67)

= 33.7

AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default assessment factor in accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health"; Table R. 8-5.
Justification:
For inhalation, DNELs allometric scaling is not usually applied.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: LC50
Value:
0.25 mg/m³
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Justification:
For inhalation, DNELs allometric scaling is not usually applied.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: LC50
Value:
0.25 mg/m³
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Justification:
For inhalation, DNELs allometric scaling is not usually applied.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 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
Value:
42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
42 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default assessment factor in accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health"; Table R. 8-5.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rats compared to humans specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-3
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
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)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
0.37 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Dose descriptor starting point:
NOAEL
Value:
42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
18.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

In accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health" (Figure R. 8.3) the oral - inhalation (route to route) dose descriptor was calculated as follows :-

NOAEC (General Population) = NOAEL x [1/1.15] x [0.5 x 1]

NOAEC (General Population) = 42 x [1/1.5] x [0.5 x 1]

NOAEC (General Population) = 18.3 mg/mg3

AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default assessment factor in accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health"; Table R. 8-5.
Justification:
For inhalation, DNELs allometric scaling is not usually applied.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 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
Value:
42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
42 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default assessment factor in accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health"; Table R. 8-5.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rats compared to humans specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-3
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information
Dose descriptor starting point:
other: LD50

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 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
Value:
42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
42 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default assessment factor in accordance with ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health"; Table R. 8-5.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rats compared to humans specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-3
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.99 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: LD50
Value:
699 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50
Value:
699 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor for rats compared to humans specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-3
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for interspecies "remaining differences" specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6
AF for the quality of the whole database:
1
Justification:
Default assessment factor for the quality of the whole database specified in the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R. 8 : Characterisation [concentration] - response for human health", Table R. 8-6

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population