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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.49 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
LOAEC
Value:
8.82 mg/m³
Explanation for the modification of the dose descriptor starting point:
A toxicokinetic study is available (Unger and Salorno, 1982) in which it is shown that oral absorption is almost 100%. Therefore, no assessment factor for route-to-route extrapolation from oral to inhalatory exposure is required.
AF for dose response relationship:
3
Justification:
Dose descriptor starting point is a LOAEC
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Has been accounted for in the route-to-route extrapolation.
AF for other interspecies differences:
1
AF for intraspecies differences:
3
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.47 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL

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:
0.07 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
LOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A toxicokinetic study is available (Unger and Salorno, 1982) in which it is shown that oral absorption is almost 100%. In the route-to-route extrapolation a complete (100%) absorption through the skin is likewise adopted, representing the worst-case situation.
AF for dose response relationship:
3
Justification:
Dose descriptor starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Test species: rat.
AF for other interspecies differences:
1
AF for intraspecies differences:
3
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
0.14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
LOAEC
Value:
4.35 mg/m³
Explanation for the modification of the dose descriptor starting point:
A toxicokinetic study is available (Unger and Salorno, 1982) in which it is shown that oral absorption is almost 100%. Therefore, no assessment factor for route-to-route extrapolation from oral to inhalatory exposure is required.
AF for dose response relationship:
3
Justification:
Dose descriptor starting point is a LOAEC
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Has been accounted for in the route-to-route extrapolation.
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL extrapolated from long term DNEL

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:
0.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
LOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A toxicokinetic study is available (Unger and Salorno, 1982) in which it is shown that oral absorption is almost 100%. In the route-to-route extrapolation a complete (100%) absorption through the skin is likewise adopted, representing the worst-case situation.
AF for dose response relationship:
3
Justification:
Dose descriptor starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Test species: rat.
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.042 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
LOAEL
Value:
5 mg/kg bw/day
AF for dose response relationship:
3
Justification:
Dose descriptor starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Test species: rat.
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Dose descriptor starting point is a NOAEL
AF for interspecies differences (allometric scaling):
4
Justification:
Test species: rat.
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population