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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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