Registration Dossier
Registration Dossier
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EC number: 205-538-1 | CAS number: 142-47-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEC
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 179 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEL
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Since only oral repeated dose studies are available, route-to-route extrapolation might be considered necessary for the long-term system dermal and inhalation DNELs.
For both oral and dermal absorption, 10% absorption is assumed and for inhalation absorption 100% is assumed, based on a toxicokinetic assessment (Tennekes, 2010).
The DNELs for human exposure are derived according to the ECETOC guidance (final draftMarch 26, 2010).
Acute DNELs for local and systemic effects
In the absence of classification for systemic and local effects after acute dermal exposure to Monosodium glutamate, no acute dermal DNELs are considered applicable.
Since exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance, no acute inhalation study was performed. In absence of further information concerning route specific effects through inhalation exposure, no acute inhalation DNELs are considered applicable.
Long-term DNELs for local effects
In absence of local effects after repeated oral exposure to monosodium glutamate, long-term DNELs for local effects were not derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 107 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEL
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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
Since only oral repeated dose studies are available, route-to-route extrapolation might be considered necessary for the long-term system dermal and inhalation DNELs.
For both oral and dermal absorption, 10% absorption is assumed and for inhalation absorption 100% is assumed, based on a toxicokinetic assessment (Tennekes, 2010).
The DNELs for human exposure are derived according to the ECETOC guidance (final draftMarch 26, 2010).
Acute DNELs for local and systemic effects
In the absence of classification for systemic and local effects after acute dermal exposure to Monosodium glutamate, no acute dermal DNELs are considered applicable.
Since exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance, no acute inhalation study was performed. In absence of further information concerning route specific effects through inhalation exposure, no acute inhalation DNELs are considered applicable.
Long-term DNELs for local effects
In absence of local effects after repeated oral exposure to monosodium glutamate, long-term DNELs for local effects were not derived.
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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