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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.8 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
264.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Complete absorption by the oral vs. the inhalation routes of exposure was assumed as well as similar toxicokinetic properties.

AF for dose response relationship:
1
Justification:
Default ECHA value
AF for differences in duration of exposure:
6
Justification:
Default ECHA value - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable in this case
AF for other interspecies differences:
1
Justification:
Not applicable in this case
AF for intraspecies differences:
5
Justification:
Default ECHA value
AF for the quality of the whole database:
1
Justification:
Default ECHA value
AF for remaining uncertainties:
1
Justification:
Not applied
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on the physical/chemical properties of the test substance, a conservative estimate of 10% dermal absorption vs. oral absorption was assumed.

AF for dose response relationship:
1
Justification:
Default ECHA value
AF for differences in duration of exposure:
6
Justification:
Default ECHA value - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA value for the rat
AF for other interspecies differences:
2.5
Justification:
Default ECHA value
AF for intraspecies differences:
5
Justification:
Default ECHA value
AF for the quality of the whole database:
1
Justification:
Default ECHA value
AF for remaining uncertainties:
1
Justification:
Not used
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:
2.2 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):
60
Modified dose descriptor starting point:
NOAEC
Value:
130.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Complete absorption by the oral vs. the inhalation routes of exposure was assumed as well as similar toxicokinetic properties.

AF for dose response relationship:
1
Justification:
Default ECHA value
AF for differences in duration of exposure:
6
Justification:
Default ECHA value - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable in this case
AF for other interspecies differences:
1
Justification:
Not applicable in this case
AF for intraspecies differences:
10
Justification:
Default ECHA value
AF for the quality of the whole database:
1
Justification:
Default ECHA value
AF for remaining uncertainties:
1
Justification:
Not used
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:
2.5 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on the physical/chemical properties of the test substance, a conservative estimate of 10% dermal absorption vs. oral absorption was assumed.

AF for dose response relationship:
1
Justification:
Default ECHA value
AF for differences in duration of exposure:
6
Justification:
Default ECHA value - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA value for the rat
AF for other interspecies differences:
2.5
Justification:
Default ECHA value
AF for intraspecies differences:
10
Justification:
Default ECHA value
AF for the quality of the whole database:
1
Justification:
Default ECHA value
AF for remaining uncertainties:
1
Justification:
Not used
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:
DNEL (Derived No Effect Level)
Value:
0.25 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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation was required.

AF for dose response relationship:
1
Justification:
Default ECHA value
AF for differences in duration of exposure:
6
Justification:
Default ECHA value - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA value for the rat
AF for other interspecies differences:
2.5
Justification:
Default ECHA value
AF for intraspecies differences:
10
Justification:
Default ECHA value
AF for the quality of the whole database:
1
Justification:
Default ECHA value
AF for remaining uncertainties:
1
Justification:
Not used
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