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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
206 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Value:
1 234 mg/m³
Explanation for the modification of the dose descriptor starting point:
It can be anticipated that no different toxic effects will be produced by the different routes of dosing because L-aspartic acid will be metabolised in each cell, where it enters the Krebs cycle and the urea cycle and where it is rapidly metabolised to CO2.
AF for dose response relationship:
1
Justification:
covered by route to route extrapolation
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
covered by route to route extrapolation
AF for other interspecies differences:
1
Justification:
covered by route to route extrapolation
AF for intraspecies differences:
3
Justification:
ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
AF for the quality of the whole database:
1
Justification:
most sensitive endpoint is reliable without restriction, and supported by other experimental data
AF for remaining uncertainties:
1
Justification:
not applicable
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:
29 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):
24
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
It can be anticipated that no different toxic effects will be produced by the different routes of dosing because L-aspartic acid will be metabolised in each cell, where it enters the Krebs cycle and the urea cycle and where it is rapidly metabolised to CO2.
AF for dose response relationship:
1
Justification:
covered by route to route extrapolation
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
covered by route to route extrapolation
AF for other interspecies differences:
4
Justification:
rat - human
AF for intraspecies differences:
3
Justification:
ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
AF for the quality of the whole database:
1
Justification:
most sensitive endpoint is reliable without restriction, and supported by other experimental data
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
61 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Value:
609 mg/m³
Explanation for the modification of the dose descriptor starting point:
It can be anticipated that no different toxic effects will be produced by the different routes of dosing because L-aspartic acid will be metabolised in each cell, where it enters the Krebs cycle and the urea cycle and where it is rapidly metabolised to CO2.
AF for dose response relationship:
1
Justification:
covered by route to route extrapolation
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
covered by route to route extrapolation
AF for other interspecies differences:
1
Justification:
covered by route to route extrapolation
AF for intraspecies differences:
5
Justification:
ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
AF for the quality of the whole database:
1
Justification:
most sensitive endpoint is reliable without restriction, and supported by other experimental data
AF for remaining uncertainties:
1
Justification:
not applicable
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:
DNEL (Derived No Effect Level)
Value:
18 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
It can be anticipated that no different toxic effects will be produced by the different routes of dosing because L-aspartic acid will be metabolised in each cell, where it enters the Krebs cycle and the urea cycle and where it is rapidly metabolised to CO2.
AF for dose response relationship:
1
Justification:
covered by route to route extrapolation
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
covered by route to route extrapolation
AF for other interspecies differences:
4
Justification:
rat - human
AF for intraspecies differences:
5
Justification:
ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
AF for the quality of the whole database:
1
Justification:
most sensitive endpoint is reliable without restriction, and supported by other experimental data
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18 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):
40
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
It can be anticipated that no different toxic effects will be produced by the different routes of dosing because L-aspartic acid will be metabolised in each cell, where it enters the Krebs cycle and the urea cycle and where it is rapidly metabolised to CO2.

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

L-aspartic acid is a naturally occurring substance. It is a basic component of proteins, together with L-glutamic acid they account for approximately 20-25 % of the total amino acid composition of dietary protein, including those found in human breast milk. L-aspartic acid enters the citric acid cycle and the urea cycle and is metabolised there. 

Protein digestion results mainly in free amino acids and small peptides in the intestinal lumen which were absorbed leading finally to blood plasma levels of L-aspartic acid between 1-25 µmol/L. Cells contain a considerable quantity of free L-aspartate. Considerable quantities of these amino acids are also found in human brain and liver.

It is obvious that human cells handle large quantities of L-aspartate / L-aspartic acid and that this amino acid is an essential component of normal cellular function.

It is therefore highly improbable that L-aspartic acid possesses any relevant toxicity.