Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
28.21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
28.21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 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):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 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):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

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:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population