Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.71 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