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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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