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EC number: 200-735-9 | CAS number: 70-47-3
- 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
Acute oral toxicity: LD50 > 16000 mg/kg bw, in female and male CFY rats, comparable to OECD Test Guideline 401, non-GLP study
Acute inhalation toxicity: No study available, particle size, partition coefficient and water solubility of the test item indicate that although its solubility is high and the partition coefficient is low, the mean median diameter is above the threshold for inhalation, thus, exposure via inhalation is not expected. Due to the low vapour pressure the exposure to aerosols is also not expected.
Acute toxicity: dermal: No study available, partition coefficient, water solubility and molecular weight indicate that the test item although small enough is considered to be highly hydrophilic and dermal penetration is considered to be very low.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 16 000 mg/kg bw
- Quality of whole database:
- The available study was conducted similar to guideline and is of sufficient quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study conducted similar to OECD Test Guideline 401, non-GLP, female and male CFY rats were administered 16000 mg/kg bw L-Asparagine and subsequently observed for 14 days, no premature mortality occurred and no adverse effects were observed, thus, the LD50 was considered to be > 16000 mg/kg bw.
Several supporting studies, either with oral administration or i.p applied L-Asparagine, all of minor reliability substantiate the results of the above mentioned study. L-Asparagine was administered with 1000, 3000 and 6000 mg/kg bw (acute) or with 1000, 500 and 250 mg/kg bw to male Sprague Dawley rats to evaluate whether L-Asparagine protects against chemically or physically induced seizures. Although L-Asparagine failed to protect against seizures, there was no sign of L-Asparagine-related toxicity in this study (Swinyard et al.). Similarily, the effect of L-Asparagine on ethanol and hexobarbital induced immobility and sleeping time was investigated. There was no sign of L-Asparagine related toxicity up to 2000 mg/kg bw, but the substance seems to aggravate the ethanol induced adverse effects (Forney et al.).
In another study L-asparagine was administered as protective agent (anticonvulsant) against pharmacologically induced seizures. The doses applied were 225 mg/kg bw and 300 mg/kg bw. In mice receiving 225 mg/kg bw and 300 mg/kg bw L-asparagine, respectively, the mortality and the occurrence of seizures were reduced by 70%. Therefore, L-asparagine is not considered to mediate adverse effects in the concentration administered (Hawkins JE).
Furthermore, the effect of infusion of several amino acids on uric acid synthesis in chicken was determined. Infusion of in total 792.7 mg/kg bw asparagine resulted in an increase of plasma uric acid of 5.6 mg/100 mL plasma and in an increase of urinary uric acid of 142.7 mg/ 50 min of infusion. No adverse effects were reported. These results indicate that asparagine is readily metabolised via urea cycle in chicken (Karasawa et al.).
According to the Draft COMMISSION REGULATION (EU) amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity, recent “scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. The oral LD50 was determined to be > 2000 mg/kg bw based on a study conducted similar to OECD guideline 401. Thus, no toxicity via the dermal route is to be expected. Based on the available information, the acute toxicity of L-Asparagine is low. There are no data gaps in acute toxicity.
Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
References:
Hawkins JE. ON THE EFFICACY OF ASPARAGINE, GLUTAMINE, y-AMINOBUTYRIC ACID AND 2-PYRROLIDINONE IN PREVENTING CHEMICALLY INDUCED SEIZURES IN MICE. Clinica Chimica Acta, Vol.2 pp. 481-484.1957
Forney RB, Hughes FW, Richards AB and Gates PW. Toxicity and Depressant Action of Ethanol and Hexobarbital after Pretreatment with Asparagine. Toxiciology and applied Pharmacology 5, 790-793.1963
Karasawa Y, Tasaki I, Yokota HO, Shibata F. Comparative Effect of Intravenously Administered Anitrogenous Compounds on Uric Acid Synthesis in Chicken Fed a 20% Protein Diet. J.Nutr. 103:1208-1211. 1973
Swinyard EA, Chin L, Cole FR and Goodman LS. Anticonvulsant Properties oi I-Glutamine and I-Asparagine in Nlice and Rats. P.S.E.B.M., 1957, v94.
Justification for classification or non-classification
Based on the available, reliable and adequate data the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) with respect to acute toxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.