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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.882 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):
25
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
22.04 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day. Then extrapolated NOEC by inhalation is calculated assuming that inhalation absorption is 100% and oral absorption is 100% : NOAEC = (12.5/0.38) *(6.7/10) = 22.04 mg/m3.

AF for dose response relationship:
1
Justification:
Default value REACH guidance
AF for differences in duration of exposure:
2
Justification:
Default value REACH guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route (REACH guidance)
AF for other interspecies differences:
2.5
Justification:
Default value REACH guidance
AF for intraspecies differences:
5
Justification:
Default value REACH guidance
AF for the quality of the whole database:
1
Justification:
The overall database is of a moderate quality, however, the selection of a NOAEL of 12.5 mg/kg bw from a 90 days toxicity study is considered to be a worst case scenario, taking into account this uncertainties.
AF for remaining uncertainties:
1
Justification:
Default value REACh guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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

Workers - Hazard via dermal 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):
100
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation needed as the oral route is the only one available: oral NOAEL rat (90 days) = 12.5 mg/kg/day.

The starting point is modified assuming a dermal absorption of 50% and an oral absorption of 100%: 12.5*(100%/50%) = 25 mg/kg/day.

AF for dose response relationship:
1
Justification:
Default value REACH guidance
AF for differences in duration of exposure:
2
Justification:
Default value REACH guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default value REACH guidance
AF for other interspecies differences:
2.5
Justification:
Default value REACH guidance
AF for intraspecies differences:
5
Justification:
Default value REACH guidance
AF for the quality of the whole database:
1
Justification:
The overall database is of a moderate quality, however, the selection of a NOAEL of 12.5 mg/kg bw from a 90 days toxicity study is considered to be a worst case scenario, taking into account this uncertainty.
AF for remaining uncertainties:
1
Justification:
Default value REACH guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance is classified acute toxicity dermal cat. 4. The danger is considered as a low hazard, therefore, only a qualitative assessment is necessary.

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 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):
50
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
10.87 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day. Then extrapolated NOEC by inhalation is calculated assuming that inhalation absorption is 100% and oral absorption is 100% : NOAEC = (12.5/1.15) *(100%/100%) = 22.04 mg/m3.

AF for dose response relationship:
1
Justification:
Default value REACH guidance
AF for differences in duration of exposure:
2
Justification:
Default value REACH guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default value REACH guidance
AF for other interspecies differences:
2.5
Justification:
Default value REACH guidance
AF for intraspecies differences:
10
Justification:
Default value REACH guidance
AF for the quality of the whole database:
1
Justification:
The overall database is of a moderate quality, however, the selection of a NOAEL of 12.5 mg/kg bw from a 90 days toxicity study is considered to be a worst case scenario, taking into account this uncertainty.
AF for remaining uncertainties:
1
Justification:
REACH guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.125 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):
200
Dose descriptor starting point:
NOAEL
Value:
12.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day.

Then extrapolated NOEL by dermal route is calculated assuming a dermal absorption of 50% and an oral absorption of 100%: NOAEL = 12.5*(100%/50%) = 25 mg/kg/day

AF for dose response relationship:
1
Justification:
Default value REACH guidance
AF for differences in duration of exposure:
2
Justification:
Default value REACH guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default value REACH guidance
AF for other interspecies differences:
2.5
Justification:
Default value REACH guidance
AF for intraspecies differences:
10
Justification:
Default value REACH guidance
AF for the quality of the whole database:
1
Justification:
The overall database is of a moderate quality, however, the selection of a NOAEL of 12.5 mg/kg bw from a 90 days toxicity study is considered to be a worst case scenario, taking into account this uncertainty.
AF for remaining uncertainties:
1
Justification:
Reach guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Category 4

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.062 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
Value:
12.5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic (ECETOC TRA 110)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factors when the species is rats (ECETOC TRA 110)
AF for other interspecies differences:
2.5
Justification:
ECETOC report 110
AF for intraspecies differences:
10
Justification:
Default factor of 5 for general public (ECETOC report 110)
AF for the quality of the whole database:
1
Justification:
Reach guidance
AF for remaining uncertainties:
1
Justification:
Reach guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population