Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.05 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):
37.5
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264.47 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.16 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.63 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
52.89 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:
other: NOAEL
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 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):
300
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Value:
420 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
170 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):
50
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
141.67 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
NOAEC
Value:
8 500 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
425 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:
8 500 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
5
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

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:
1.74 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):
75
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Value:
111 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.22 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
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.04 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:
other: NOAEL
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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):
300
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
85 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:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.83 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
NOAEC
Value:
8 500 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
212.5 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:
8 500 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
1
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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):
300
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for differences in duration of exposure:
3
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
85 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:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment factor.
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment factor.
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment factor.
AF for intraspecies differences:
10
Justification:
Default ECHA assessment factor.
AF for the quality of the whole database:
1
Justification:
Default ECHA assessment factor.
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment factor.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population