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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.7 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):
75
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
52.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA REACH Guidance

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Still covered by route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33 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):
300
Dose descriptor starting point:
NOAEL
Value:
30 ng/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see comment

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
According to ECHA REACH Guidance for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
0.175 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):
150
Dose descriptor starting point:
NOAEL
Value:
30 ng/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.25 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA REACH Guidance

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Still covered by route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
16 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see comment

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
DNEL (Derived No Effect Level)
Value:
0.05 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):
600
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance: Default value for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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