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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.87 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
123 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
sRVrat: 0,38 m3/kg bw
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSinh-human: 100 %
sRVhuman: 6,7 m3/kg bw
wRV: 10 m3/person
Correction for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk)
AF for dose response relationship:
1
Justification:
The starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling factor: not applicable (already included during the route-to-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
default value for other remaining differences
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Starting point from a reliable chronic data
AF for remaining uncertainties:
1
Justification:
not applicable
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:
2.8 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):
50
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
140 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSder-human: 50 % (in accordance with SCCS 2021)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk)
AF for dose response relationship:
1
Justification:
The starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rats.
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Starting point from a reliable chronic data
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
1.74 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
43 mg/m³
Explanation for the modification of the dose descriptor starting point:

oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
sRVrat: 1,15 m3/kg bw
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSinh-human: 100 %

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling factor: not applicable (already included during the route-to-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
Default value for other remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Starting point from a reliable chronic data
AF for remaining uncertainties:
1
Justification:
not applicable
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:
1 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSder-human: 50 % (in accordance with SCCS 2021)

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Starting point from a reliable chronic data
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
0.5 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):
100
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

no modification applied.

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The starting point is from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rats.
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences.
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Starting point from a reliable chronic data
AF for remaining uncertainties:
1
Justification:
not applicable
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