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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.3 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:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor for the extrapolation of subacute studies
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
1
Justification:
standard factor
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 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):
10
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
0.2
Justification:
Extrapolation from subactue study to acute study

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low 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:
3.33 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The LD50 dermal is >2000 mg/kg, indicating absent / low dermal absorption or non-toxicity. The substance is also not bioavailable on the oral route according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor for extrapolation subacute -> chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
1
Justification:
standard factor
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

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:
5.83 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:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
10
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
standard factor
AF for remaining uncertainties:
1
Justification:
standard factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

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

General Population - Hazard via dermal route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population