Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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