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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.5 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
15 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
6
Justification:
ECHA defaults Table R8.6 - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA defaults Table R8.6 - rat
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
5
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
1
Justification:
ECHA defaults Table R8.6
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study available
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
6
Justification:
ECHA defaults Table R8.6 - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA defaults Table R8.6 - rat
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
5
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
1
Justification:
ECHA defaults Table R8.6
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.73 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor:
other: LOAEL
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
1
Justification:
Increasing exposure duration will not increase the incidence or severity of adverse effects, which applies to most local dermal effects.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA defaults Table R8.6
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
5
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
3
Justification:
Default AF for vehicle and matrix effect
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.73 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA defaults Table R8.6
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
5
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
3
Justification:
Default AF for vehicle and matrix effect

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
0.013 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
7.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation studies available
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
6
Justification:
ECHA defaults Table R8.6 - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA defaults Table R8.6 - rat
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
10
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
1
Justification:
ECHA defaults Table R8.6
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study available
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
6
Justification:
ECHA defaults Table R8.6 - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA defaults Table R8.6 - rat
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
10
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
1
Justification:
ECHA defaults Table R8.6
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.87 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
other: LOAEL
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
1
Justification:
Increasing exposure duration will not increase the incidence or severity of adverse effects, which applies to most local dermal effects.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA defaults Table R8.6
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
10
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
3
Justification:
Default AF for vehicle and matrix effect
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.87 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA defaults Table R8.6
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
10
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
3
Justification:
Default AF for vehicle and matrix effect

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
/
AF for dose response relationship:
1
Justification:
ECHA defaults Table R8.6
AF for differences in duration of exposure:
6
Justification:
ECHA defaults Table R8.6 - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA defaults Table R8.6 - rat
AF for other interspecies differences:
2.5
Justification:
ECHA defaults Table R8.6
AF for intraspecies differences:
10
Justification:
ECHA defaults Table R8.6
AF for the quality of the whole database:
1
Justification:
ECHA defaults Table R8.6
AF for remaining uncertainties:
1
Justification:
ECHA defaults Table R8.6
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population