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EC number: 200-291-6 | CAS number: 56-84-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Additional information
Abbreviations used: L-ASP for L-aspartic acid; SA for succinic acid.
A weight of evidence approach is applied for each of the acute aquatic toxicity endpoints fish, Daphnia, alga. This approach is based on:
1. A read across to data for the analogous substance
succinic acid, which only lack a NH2-group compared to L-aspartic acid
and which has comparable physical-chemical properties, is justified and
was performed. More details on the read across approach are found in the
attachments to the individual endpoints, where a read across was
applied. Comparative results for L-ASP and SA are:
L-ASP, non-adjusted pH of 4.3, EC50algae = 8.5 mg/L
L-ASP, non-adjusted pH of 6.5, EC50Daphnia = 165 mg/L
SA, non-adjusted pH of 4.2, EC50algae = 46.8 mg/L
SA, adjusted pH to ca. neutral, EC50algae >100 mg/L
SA, non-adjusted pH of 4.7, EC50daphnia = 63 mg/L
SA, adjusted pH to ca. neutral, EC50daphnia >100 mg/L
SA, non-adjusted pH 6.2, LC50fish > 100 mg/L
2. It is assumed and is confirmed by the
results presented above that the pH (or the H+ ion concentration) is the
relevant parameter for describing toxicity and not the effects to
specific targets of the organisms. The EC50/LC50 are lower in tests with
initially low pH compared to the tests with pH adjusted to ca. neutral.
A correlation between pH and EC/LC50 exists for the tests with
non-adjusted pH.
3. QSAR estimations predicted a low toxicity
for each of the 3 aquatic organisms. This also confirms the assumption
that no relevant toxicity is expected for L-ASP at neutral pH, because
QSAR calculations generally refer to the undissociated molecule.
L-ASP, EC50algae = 2237 mg/L
L-ASP, EC50Daphnia = 607; 2187; >>1000 mg/L, for the 3 models used.
L-ASP, LC50fish = >100; 872, >>1000 mg/L, for the 3 models used.
4. The test media have a different buffer
capacity so that the initial pH in the media with a concentration of ca.
100 mg test substance/L varies for the tests with the different
organisms:
L-ASP, 120 mg/L, algae: pH = 4.3
L-ASP, 150 mg/L, Daphnia: pH = 6.5
SA, 100 mg/L, algae: pH = 4.2
SA, 100 mg/L, Daphnia: pH = 4.7
SA, 100 mg/L, fish: pH = 6.2
Especially for SA, for which each of the tests were performed in the
same laboratory at 100 mg/L, it can be derived that the buffer capacity
of the medium used increases from algae to Daphnia and being highest for
fish.
5. From the last point, i.e. the highest pH of the medium in the fish study, it is further derived that in a fish test the highest EC50/LC50 will be obtained compared to tests with the other organisms. This is confirmed when looking at the results, as summarised in point 1, above.
6. It is therefore justified to waive the
acute fish toxicity test because no new data, respectively a higher LC50
(compared to alga and Daphnia), are expected.
Instead of, the LC50 is transcribed from the LC50 >100 mg SA/L, by
accounting for the slightly different molecular weight of SA and L-ASP,
to give LC50fish > 113 mg L-ASP/L.
7. The performance of the test with
non-adjusted pH is not in conformance with agreed procedures and
therefore the results from these tests should not be used for
classification or risk assessment. The remarkable lowering of the pH at
the higher concentrations of L-ASP (and also SA) explains the inhibition
of the growth rate of the algae or the lower EC50 for Daphnia (for SA),
which is not due to the chemical structure of the substance but to the
H+ concentration.
Although the OECD 202 method requires to perform first the test without
adjusting the pH, it also describes to perform a second run with
adjusting the pH: "If the pH does not remain in the range 6-9, then a
second test could be carried out, adjusting the pH of the stock solution
to that of the dilution water before addition of the test substance" and
"The pH should normally not vary by more than 1.5 units in any one test."
No requirement is given in the OECD 201 method to adjust the pH in the
case of ionised substances, but there are two relevant documents
requiring it:
- The ECHA Guidance Document on Info Requirement and CSA, R.7b (Version
November 2012, Table R. 7.8-3: "Summary of difficult substance testing
issues", page 77 for pH effects) states: "Where a substance causes a
change in pH of the test medium (e.g. strong acids and bases), the pH
should be adjusted to lie within the specified range for the test using
a suitable technique. ...".
- Also the OECD Document on Aquatic Toxicity Testing of Difficult
Substances and Mixtures, OECD Series on testing and assessment, No. 23
of 2000, states in Section 3.1: "Where the substance itself causes a
change to the pH of the test medium, the pH should be adjusted to lie
within the specified range for the test using acid, alkali or other
suitable buffer. ...".
The studies without adjustment of the pH to ca. neutral are therefore
considered to be of only restricted adequacy for REACH. It is
foreseeable and has been shown for succinic acid (and also for other
acids such as HCl) that a test with an adjusted pH to ca. neutral will
cause no toxicity to the aquatic organisms.
It would be more reasonable to state that the aquatic toxicity is
dependent on the initial pH and that a concentration of any test
substance that lowers the pH below ca. 7 in the specific water medium
used has a toxic effect to the aquatic organisms. The buffering capacity
will be dependent on the actual aqueous environment, therefore relating
the EC50 to a concentration is not relevant for the actual situation,
only the resulting pH will be.
8. Test results at low initial pH are not relevant, also because a pH of between 6 and 9 has to be maintained anyway if the Directive 2006/44/EC of the European Parliament and of the Council of 6 September 2006 on "the quality of fresh waters needing protection or improvement in order to support fish life" is observed.
9. The test result of the algae test with L-ASP is therefore not used for classification and risk assessment. Instead of the EC50 is transcribed from the EC50 >100 mg SA/L, by accounting for the slightly different molecular weight of SA and L-ASP, to give EC50algae > 113 mg L-ASP/L.
10. The same procedure could be applied for the Daphnia result, but as a worst case it was accepted to use the EC50 = 165 mg/L, obtained from the study with L-ASP.
11. The inhibition of respiration of microorganisms could be waived, based on the readily biodegradability of L-ASP, which indicates a low toxicity to microorganisms. To obtain a more concrete data a read across was performed to SA.
12. The amino acid L-aspartic acid is probably a nutrient for most of the organisms.
Long-term tests are waived because no classification and no risk assessment has to be performed. Also, the long-term test results will be dependent on the resulting pH of the solutions of L-ASP and the result is therefore foreseeable, i.e. no toxicity will be observed at pH >6, endorsed by the EU Directive 2006/44/EC, see above.
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