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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.71 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
Modified dose descriptor starting point:
NOAEC
Value:
53 mg/m³
Explanation for the modification of the dose descriptor starting point:
Corrected inhalative systemic NOAEL following route-to route-extrapolation with factors as in guidance R.8: oral NOAEL= 30mg/kg/day *6.7/10/0.38. The high water solubility of MODA, the caustic effects and the partition coefficient log Kow of 2 allowed the assumption of equal distribution in the organisms. As described in chapter 7.1 of this IUCLID file oral and inhalation absorption was taken to 100%. In consequence the route-to-route extrapolation factor is 1. This is confirmed by ECETOC TGD 110. Molecules with a molecular weight < 500 and a log Kow between 0 and 4 can be assumed to be well absorbed equivalently by the oral and inhalation route.
AF for dose response relationship:
1
Justification:
guidance R.8 default
AF for differences in duration of exposure:
6
Justification:
guidance R.8 default
AF for interspecies differences (allometric scaling):
1
Justification:
guidance R.8 default
AF for other interspecies differences:
1
Justification:
guidance R.8 default
AF for intraspecies differences:
5
Justification:
guidance R.8 default
AF for the quality of the whole database:
1
Justification:
valid study available for point of departure
AF for remaining uncertainties:
2.5
Justification:
guidance R.8 default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A worst case assumption of 100% dermal absorption is used (route to route extrapolation factor 1). Corrosivity and follow up effects were the main symptoms in the oral study.
AF for dose response relationship:
1
Justification:
guidance R.8 default
AF for differences in duration of exposure:
6
Justification:
guidance R.8 default
AF for interspecies differences (allometric scaling):
4
Justification:
guidance R.8 default
AF for other interspecies differences:
1
Justification:
guidance R.8 default
AF for intraspecies differences:
5
Justification:
guidance R.8 default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Justification:
guidance R.8 default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
0.17 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
Modified dose descriptor starting point:
NOAEC
Value:
26 mg/m³
Explanation for the modification of the dose descriptor starting point:
Corrected inhalative systemic NOAEL following route-to route-extrapolation with factor 0.87 as in guidance R.8 (oral NOAEL= 30mg/kg/day * 0.87)
AF for dose response relationship:
1
Justification:
guidance R.8 default
AF for differences in duration of exposure:
6
Justification:
guidance R.8 default
AF for interspecies differences (allometric scaling):
1
Justification:
guidance R.8 default
AF for other interspecies differences:
1
Justification:
guidance R.8 default
AF for intraspecies differences:
10
Justification:
guidance R.8 default
AF for the quality of the whole database:
1
Justification:
guidance R.8 default
AF for remaining uncertainties:
2.5
Justification:
guidance R.8 default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 µg/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
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A worst case assumption of 100% dermal absorption is used. Corrosivity and follow up effects were the main symptoms in the oral study.
AF for dose response relationship:
1
Justification:
guidance R.8 default
AF for differences in duration of exposure:
6
Justification:
guidance R.8 default
AF for interspecies differences (allometric scaling):
4
Justification:
guidance R.8 default
AF for other interspecies differences:
1
Justification:
guidance R.8 default
AF for intraspecies differences:
10
Justification:
guidance R.8 default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Justification:
guidance R.8 default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 µg/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
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
AF for dose response relationship:
1
Justification:
guidance R.8 default
AF for differences in duration of exposure:
6
Justification:
guidance R.8 default
AF for interspecies differences (allometric scaling):
4
Justification:
guidance R.8 default
AF for other interspecies differences:
1
Justification:
guidance R.8 default
AF for intraspecies differences:
10
Justification:
guidance R.8 default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Justification:
guidance R.8 default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

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