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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9.4 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
705.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOAEC for workers.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
56.4 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
705.26 mg/m³
AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.

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:
1.33 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.

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:
high hazard (no threshold derived)

Additional information - workers

As basis for DNEL derivation the result from a 28 day repeated toxicity study via oral was used. The NOAEL is this subacute toxicity is established as 400 mg/kg/day.

No factor was introduced in the route to route extrapolation based on toxicokinetic assessment of absorption. Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOAEC for workers. Based on toxicokinetic assessment, the absorption rate from dermal route is considered to be same as oral route. The NOAELcorr for dermal therefore remains unchanged.

The local effects are with low hazard (no threshold derived) due to the lack of significant response observed in available studies. The hazard for eyes however is considered to be high (no threshold derived) based on serious irritant effects observed in eye irritation study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.32 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
347.83 mg/m³
Explanation for the modification of the dose descriptor starting point:

Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOAEC for general population.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.32 mg/m³
DNEL related information

Local effects

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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 mg/kg bw/day
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation is applied.

AF for dose response relationship:
1
Justification:
The default assessment factor for NOAEL is 1.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 mg/kg bw/day
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

As basis for DNEL derivation the result from a 28 day repeated toxicity study via oral was used. The NOAEL is this subacute toxicity is established as 400 mg/kg/day.

No factor was introduced in the route to route extrapolation based on toxicokinetic assessment of absorption. Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOAEC for general population. Based on the toxicokinetic assessment, the absorption rate from dermal route is considered to be same as oral route. The NOAELcorr for dermal therefore remains unchanged.

The local effects are with low hazard (no threshold derived) due to the lack of significant response observed in available studies. The hazard for eyes however is considered to be high (no threshold derived) based on serious irritant effects observed in eye irritation study.