Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9.87 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