Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.8 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):
80
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL = 250 mg/kg bw/day (OECD 408)

NOAEC = 437.5 mg/m³ according to ECHA’s guideline R.8, Example R.8-2.

The allometric scaling factor of 4 is already included into the NOAEC.

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
none known
AF for intraspecies differences:
5
Justification:
human to worker
AF for the quality of the whole database:
1
Justification:
good/standard quality of the database with respect to
completeness, consistency and the standard information requirements
AF for remaining uncertainties:
2
Justification:
route of exposure (oral -> inhalative)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
258 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
other: LC50
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:

Starting point is the LC50(inhalative) of 5.16 mg/l, which is considered to be the NOAEC in this case.

AF for dose response relationship:
1
Justification:
LC50 can be considered as NOAEC in this case
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
none known
AF for intraspecies differences:
5
Justification:
human to worker
AF for the quality of the whole database:
1
Justification:
good/standard quality of the database with respect to
completeness, consistency and the standard information requirements)
AF for remaining uncertainties:
1
Justification:
none known

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:
6.3 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
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL = 250 mg/kg bw/day (OECD 408)

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
none known
AF for intraspecies differences:
5
Justification:
human to worker
AF for the quality of the whole database:
1
Justification:
good/standard quality of the database with respect to
completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
none known
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 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):
20
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL = 250 mg/kg bw/day (OECD 408)

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
none known
AF for intraspecies differences:
5
Justification:
human to worker
AF for the quality of the whole database:
1
Justification:
good/standard quality of the database with respect to
completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
none known

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:
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
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
Most sensitive endpoint:
acute toxicity
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

No exposure to general population