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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.9 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:
330 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
290.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral NOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 330 mg/kg bw/day × 1/0.38 × 6.7/10 × 50/100

Inhalation NOAEChuman= 290.9 mg/m³

AF for dose response relationship:
1
Justification:
A clear NOAEL was obtained
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
5
Justification:
default value for workers
AF for the quality of the whole database:
2
Justification:
Read across used.
AF for remaining uncertainties:
2.5
Justification:
any remaining difference
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
other: NOEL
Value:
96.98 mg/m³
AF for dose response relationship:
1
Justification:
A clear NOEL for local effects was obtained and was used to define the modified starting point for local effects (NOEC)
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for inhalation
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
5
Justification:
default value for workers
AF for the quality of the whole database:
2
Justification:
read across used
AF for remaining uncertainties:
1
Justification:
Default value for local effects
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):
600
Dose descriptor starting point:
NOAEL
Value:
330 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 650 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral NOAELrat× (50%/10%) = 330 mg/kg/day x 5

Dermal NOAELhuman= 1650 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was obtained
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
5
Justification:
deafult value for workers
AF for the quality of the whole database:
2
Justification:
read across used
AF for remaining uncertainties:
2.5
Justification:
Default value for any remaining difference
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.48 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):
300
Dose descriptor starting point:
NOAEL
Value:
330 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
143.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral NOAELrat× (1/1.15 m3/kg bw) × (50%/100%) = 330 mg/kg bw/day × 1/1.15 × 50/100

AF for dose response relationship:
1
Justification:
A clear NOAEL was obtained
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
1
Justification:
No other differences
AF for intraspecies differences:
10
Justification:
default value for general public
AF for the quality of the whole database:
2
Justification:
read across used
AF for remaining uncertainties:
2.5
Justification:
Default value for any remaining differences
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Dose descriptor:
other: NOEL
Value:
47.83 mg/m³
AF for dose response relationship:
1
Justification:
A clear NOEL was obtained
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for inhalation or local effects
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
Read across used
AF for remaining uncertainties:
1
Justification:
Default value for any remaining differences for local effects
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:
1.4 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
330 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 650 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction of the starting point: Oral NOAELrat× (50%/10%) = 330 mg/kg/day x 5

Dermal NOAEChuman= 1650 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was obtained
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rat
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
read across used
AF for remaining uncertainties:
2.5
Justification:
Default value for any remaining difference
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low 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:
0.28 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
330 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
330 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral NOAELrat= Oral NOAELhuman= 330 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL has been defined in a compliant GLP OECD 407 study
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat
AF for other interspecies differences:
1
Justification:
No other differences expected
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
read across used
AF for remaining uncertainties:
2.5
Justification:
Default for any remaining differences
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

An oral repeat dose rat study identified a NOEL of 110 mg/kg/day, at 330 mg/kg (defined as the NOAEL). There were marked effects at the portal-of-entry (stomach) and all other findings were attributed to local effects of irritation in the stomach. It is therefore considered relevant to calculate a DNELoral-local for the general population:

Correction of the starting point: Oral NOELrat= Oral NOELhuman= 110 mg/kg bw/day

 AF:

dose reseponse = 1 (defined NOEL set)

allometric scaling (rat to human) = 1 (not applicable for local effects as the mode of action/mechanism is considered to be the same)

other interspecies differences = 1 (no other differences)

remaining differences = 1 (local effect in the stomach)

duration of exposure = 6 (subacute to chronic)

quality of dataset = 2 (read across)

intraspecies differences = 10 (default for general public)

total AF = 120

Therefore DNELoral= 110 mg/kg bw/day/120

DNELoral-local= 0.92 mg/kg bw/day