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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.2 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:
9.7 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
1
Justification:
2 year study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 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):
16.7
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
9.7 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
2 year study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
16.7
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.37 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
91 day study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.11 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
33
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for remaining uncertainties:
2
Justification:
91 day study

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
2
Justification:
91 day study
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.63 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3.3
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for remaining uncertainties:
2
Justification:
91 day study

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:
0.048 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):
100
Modified dose descriptor starting point:
NOAEC
Value:
4.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
1
Justification:
2 year study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.144 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):
33
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
4.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.048 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
2 year study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.144 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
33
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.185 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
91 day study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.555 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
66.7
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
AF for remaining uncertainties:
2
Justification:
91 day study

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.104 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
2
Justification:
91 days
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.312 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6.7
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
AF for remaining uncertainties:
2
Justification:
91 day study

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.11 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:
11 mg/kg bw/day
AF for differences in duration of exposure:
1
Justification:
2 year study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
33
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
11 mg/kg bw/day
AF for dose response relationship:
0.3
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population