Registration Dossier
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EC number: 203-537-0 | CAS number: 107-96-0
Toxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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