Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
357.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
8 927.75 mg/m³
Explanation for the modification of the dose descriptor starting point:

6.7/10 m3was considered appropriate to address the different respiratory volumes between individuals at rest and workers under light work activity.

AF for dose response relationship:
1
Justification:
This is the default value.
AF for differences in duration of exposure:
2
Justification:
A scaling factor for using a subchronic study for a chronic endpoint was used.
AF for interspecies differences (allometric scaling):
2.5
Justification:
Data produced for rats is used to derive a human DNEL.
AF for intraspecies differences:
5
Justification:
A factor of 5 is selected for workers.
AF for the quality of the whole database:
1
Justification:
The data is of good quality (from guideline studies).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 856.88 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
35 711 mg/m³
Explanation for the modification of the dose descriptor starting point:

6.7/10 m3was considered appropriate to address the different respiratory volumes between individuals at rest and workers under light work activity.

AF for dose response relationship:
1
Justification:
This is the default value.
AF for interspecies differences (allometric scaling):
2.5
Justification:
Data produced for rats is used to derive a human DNEL.
AF for intraspecies differences:
5
Justification:
A factor of 5 is selected for workers.
AF for the quality of the whole database:
1
Justification:
The data is of good quality (from guideline studies).

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:
no hazard identified
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:
266.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
13 325 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
A scaling factor for using a subchronic study for a chronic endpoint was used.
AF for interspecies differences (allometric scaling):
2.5
Justification:
Data produced for rats is used to derive a human DNEL.
AF for intraspecies differences:
10
Justification:
A factor of 10 is selected for the general population.
AF for the quality of the whole database:
1
Justification:
The data is of good quality (from guideline studies).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 132 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
53 300 mg/m³
AF for dose response relationship:
1
Justification:
Default value.
AF for interspecies differences (allometric scaling):
2.5
Justification:
Data produced for rats is used to derive a human DNEL.
AF for intraspecies differences:
10
Justification:
A factor of 10 is selected for the general population.
AF for the quality of the whole database:
1

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:
no hazard identified
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