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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9.8 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
Modified dose descriptor starting point:
NOAEC
Value:
246 mg/m³
Explanation for the modification of the dose descriptor starting point:

No specific metabolism expected, thus oral to inhalation extrapolation based on absorption, which is considered 100% for both routes of exposure.

AF for dose response relationship:
1
Justification:
Based on derivation of the NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
standard factor for workers
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity, the DNEL is provisional
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 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:
140 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No specific metabolism expected, thus oral to dermal extrapolation based on absorption, which is considered 100% for both routes of exposure.

AF for dose response relationship:
1
Justification:
Based on derivation of the NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity; the DNEL is provisional.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

To protect for corrosion effects to eyes, specific personal protection equipment will be prescribed.

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):
50
Modified dose descriptor starting point:
NOAEC
Value:
87 mg/m³
Explanation for the modification of the dose descriptor starting point:

No specific metabolism expected, thus oral to inhalation extrapolation based on absorption, which is considered 100% for both routes of exposure.

AF for dose response relationship:
1
Justification:
Based on derivation of the NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
2.5
Justification:
according to ECHA guidance
AF for intraspecies differences:
10
Justification:
standard factor for general population (ECHA)
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity; The DNEL is provisional
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium 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:
0.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No specific metabolism expected, thus oral to dermal extrapolation based on absorption, which is considered 100% for both routes of exposure.
AF for dose response relationship:
1
Justification:
Based on derivation of the NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
2.5
Justification:
according to ECHA guidance
AF for intraspecies differences:
10
Justification:
according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity. The DNEL is provisional.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
Based on derivation of the NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
2.5
Justification:
according to ECHA guidance
AF for intraspecies differences:
10
Justification:
according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity. The DNEL is provisional.
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

To protect for corrosion effects to eyes, specific personal protection equipment will be prescribed.