Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.57 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
DNEL value:
264.25 mg/m³
Explanation for the modification of the dose descriptor starting point:
Oral exposure is highly unexpected. Inhalation exposure is predictible due to the products in which the substance is contained.
AF for dose response relationship:
1
Justification:
When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
2
Justification:
The default assessment factor for subchronic to chronic is 2
AF for interspecies differences (allometric scaling):
2.5
Justification:
Default AF for interspecies
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
Data used in the DNEL derivation are reliable
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:
7.5 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):
40
Modified dose descriptor starting point:
other: NOAEC
DNEL value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral exposure is highly unexpected. Inhalation exposure is predictible due to the products in which the substance is contained.
AF for dose response relationship:
1
Justification:
When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
2
Justification:
the default assessment factor for subchronic to chronic is 2
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for interspecies
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
Data used in the DNEL derivation are reliable
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:
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:
5.28 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
DNEL value:
264.47 mg/m³
Explanation for the modification of the dose descriptor starting point:
Oral exposure is highly unexpected. Inhalation exposure is predictible due to the products in which the substance is contained.
AF for dose response relationship:
1
Justification:
When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
2
Justification:
The default assessment factor for subchronic to chronic is 2
AF for interspecies differences (allometric scaling):
2.5
Justification:
Default AF for interspecies
AF for intraspecies differences:
10
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
Data used in the DNEL derivation are reliable
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:
3.75 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):
80
Modified dose descriptor starting point:
other: NOAEC
DNEL value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral exposure is highly unexpected. Inhalation exposure is predictible due to the products in which the substance is contained.
AF for dose response relationship:
1
Justification:
When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
2
Justification:
The default assessment factor for subchronic to chronic is 2
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for interspecies
AF for intraspecies differences:
10
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
Data used in the DNEL derivation are reliable
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population