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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
12 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:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation Inhalation NOAEC : 1000 x (1/0.38) x (100/100) x (6.7/10) = 1763 mg/m3.
AF for dose response relationship:
1
Justification:
No anticipated adverse effects for what is effectively a source of energy within the body.
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating from subacute to chronic duration.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required after correction to inhalation starting point.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
5
Justification:
Default intraspecies factor for workers.
AF for the quality of the whole database:
1
Justification:
Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, not adverse toxicity is anticipated for what is effectively a source of energy within the body.
AF for remaining uncertainties:
2
Justification:
Use of read-across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27 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):
150
Modified dose descriptor starting point:
NOAEL
Value:
4 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL : Dermal : NOAEL 1000 x (100/25) = 4000
AF for dose response relationship:
1
Justification:
No anticipated adverse effects for what is effectively a source of energy within the body.)
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating from subacute to chronic duration.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required – same metabolism in mammalian species
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
5
Justification:
Default intraspecies factor for workers.
AF for the quality of the whole database:
1
Justification:
Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, not adverse toxicity is anticipated for what is effectively a source of energy.
AF for remaining uncertainties:
2
Justification:
Use of read-across
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:
medium hazard (no threshold derived)

Additional information - workers

The material would revert to glutamate and the fatty acids in the gastro-intestinal trac prior to absorption, by the action of peptidases and proteases in the stomach. Absorption of these components which are endogenous metabolites and very common dietary components can be considered to be 100%.

Dermal absorption can be considered to be no more than 25% in accordance with EFSA guidance.

In the absence of specific data to show otherwise, inhalation absorption is set to 100%.

The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route. It is not irritating to the skin and has no skin sensitisation potential, but it causes serious eye irritation (Cat. 2 – medium hazard), although no data on dose-response are available.

No repeat-dose toxicity study is available, and a read-across approach of the two main constituents using bespoke QSARs created in the OECD QSAR Toolbox, tailored to both the substance and the endpoint, have been used to derive expected NOELs for repeated oral exposure. The repeated dose (subacute) oral toxicity No Observed Effect Level (NOEL) of sodium hydrogen N-(1-oxohexadecyl) -L-glutamate was determined to be 1740 mg/kg bw/day in the rat via oral gavage. The oral gavage (subacute) NOEL in rats for Sodium hydrogen N-(1-oxooctadecyl) -L-glutamate was determined to be ca. 1509.8 mg/kg bw/day. Considering that for both components the expected repeat-dose NOELs, assumed for a subacute exposure as a worst-case condition, are above the limit dose, the limit dose of 1000 mg/kg bw/day has been used as the subacute starting point for deriving the long-term systemic DNELs.

The test material was not genotoxic, and no known precedent for reproductive or developmental toxic potential was found using a read-across approach of the two main constituents, using bespoke QSARs created in the OECD QSAR Toolbox.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC : Inhalation NOAEC : 1000 x (1/1.15) x (100/100) = 870 mg/m3/day
AF for dose response relationship:
1
Justification:
No anticipated adverse effects for what is effectively a source of energy within the body.
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating from subacute to chronic duration.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
10
Justification:
Default intraspecies factor for the general population.
AF for the quality of the whole database:
1
Justification:
Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, not adverse toxicity is anticipated for what is effectively a source of energy within the body.
AF for remaining uncertainties:
2
Justification:
Use of read-across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 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:
4 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL : Dermal NOAEL : 1000 x (100/25) = 4000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
No anticipated adverse effects for what is effectively a source of energy within the body.
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating from subacute to chronic duration.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
10
Justification:
Default intraspecies factor for the general population.
AF for the quality of the whole database:
1
Justification:
Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, not adverse toxicity is anticipated for what is effectively a source of energy within the body.
AF for remaining uncertainties:
2
Justification:
Use of read-across
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:
DNEL (Derived No Effect Level)
Value:
3 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation required
AF for dose response relationship:
1
Justification:
No anticipated adverse effects for what is effectively a source of energy within the body.
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating from subacute to chronic duration.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required – same metabolism in mammalian species.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
10
Justification:
Default intraspecies factor for the general population.
AF for the quality of the whole database:
1
Justification:
Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, not adverse toxicity is anticipated for what is effectively a source of energy within the body.
AF for remaining uncertainties:
2
Justification:
Use of read-across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The same endpoint used for deriving long-term systemic DNELs for workers has been used for the general population. The larger AF for intraspecies sensitivity is considered to be sufficiently protective.