Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.08 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:
156 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr=NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 88.3 mg/kg/d*(1/0.38 m³/kg/d)*0.67 =156 mg/m³. It is assumed that oral absorption rate is 100% of that of inhalation absorption. ABSoral/rat=oral absorption rate in rats, ABSinh./human=inhalation absorption rate in humans
AF for dose response relationship:
1
Justification:
ECHA default factor
AF for differences in duration of exposure:
6
Justification:
ECHA default factor for subacute test (DNEL is based on oral 28d study)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already applied in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default factor
AF for intraspecies differences:
5
Justification:
ECHA default factor for workers
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
ECHA default factor OECD 422 available
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.59 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):
1 500
Modified dose descriptor starting point:
NOAEL
Value:
883 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A key oral 28-day toxicity study is available; there was no repeated dose dermal toxicity study available
AF for dose response relationship:
1
Justification:
ECHA default factor
AF for differences in duration of exposure:
6
Justification:
ECHA default factor for subacute test
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already applied in route to route extrapolation
AF for other interspecies differences:
10
Justification:
ECHA default factor. For more information please refer to ECHA GD R8, 2012 pg 23-45
AF for intraspecies differences:
5
Justification:
ECHA default factor workers
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
5
Justification:
In absence of a reproduction toxicity screening study, a factor 5 was applied
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
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

For 3-MPA no European or international occupational exposure limit (OEL) exists so far. Thus, the present DNELs should be regarded as critical limit values to avoid adverse effects in humans. Despite strictly controlled conditions, workers might be exposed to 3-MPA during manufacture, processing or filling the substance in appropriate containers.

The DNELs derived for long-term systemic dermal and inhalation effects are the most sensitive ones. They are based on a 28-day study with MMP (the methyl ester of 3-MPA). The adjusted dose descriptor is the NOAEL of 88.3 mg/kg/d corrected for the lower MW of 3-MPA compared to MMP.

Long-term systemic effects caused by inhalation of 3-MPA are not expected to occur as long as the exposedworkerscomply with theDNEL long-term systemic for inhalation of 2.08 mg/m³. For dermal exposure theworker-DNEL long-term for dermal route – systemic of 0.59 mg/kg bw/dis the critical limit value.

The highly corrosive effects of 3-MPA to the skin and eyes are predominantly relevant and have to be accounted for.

Since exposure of the general public is not relevant, DNELs for the general population are not needed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNELs for the general population are not needed. There is no 3-MPA exposure scenario that involves the general population.