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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- The study was conducted prior to implementation of OECD and GLP guidlines
- Principles of method if other than guideline:
- - Principle of test:
The twenty five amino acids were prepared as 30% solutions in water or as 30% suspensions in 1 % methyl cellulose and administered by gastric intubation at a maximum dosage volume of 53.3 ml/kg bodyweight. This gave a maximum practical dose of 16 g amino acid /kg bodyweight. The observation period was 14 days.
During the the observation period, a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and animals surviving terminally were similarly examined to detect possible residual damage. Assessment of degree of recovery from the initial toxic action of the product was made subjectively from appearance and behaviour of the animals and, more objectively, by weekly checks on bodyweight. Where the mortality data indicated that the LD50 was below the maximum practical dosage (16 g/kg bodyweight), the LD50 and its 95% confidence limits were calculated by the method of Litchfield, J.T., and Wilcoxon, F. (1949) J. Pharmac. exp. Ther, 96, 99.
- Short description of test conditions:
The rats used in these tests were of the CFY strain.
At the time of dosing they were in the weight range of 62 to 123g. Each animal was deprived of food for 20 h prior to dosing, after which food was withheld for a further 4 hours.
- Parameters analysed / observed:
Rats that died were examined macroscopically. Assessment of degree of recovery from the initial toxic action was made subjectively from appearance and behaviour of the animals, more objectively, by weekly checks on body weight. In case of death of an animal that received less than the maximum dose, the LD50 was determined. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Asparagine
- EC Number:
- 200-735-9
- EC Name:
- Asparagine
- Cas Number:
- 70-47-3
- Molecular formula:
- C4H8N2O3
- IUPAC Name:
- asparagine
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: females: 85 and 76 g and males: 83 and 78 g
- Fasting period before study: 20 hrs prior to dosing and 4h after dosing
- Housing: caged in groups according to sex and dosage
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 30% solutions in water or 30% suspensions in 1% methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: maximum concentration in vehicle: 0.3 g/mL (16 g/kg/53.3 mL/kg = 0.3 g/mL)
- Amount of vehicle (if gavage): maximum dosage volume 53.3 mL/kg bw.
- Doses:
- 0 and 16 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weekly determination of body weight, clinical signs, mortality
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- In case of L-asparagine no preliminary test was recorded. Only one dose was documented.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no adverse effects were detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this acute oral toxicity study rats were administered L-asparagine at a dose of 16 g/kg bw by oral gavage. Since there was no mortality and clinical symptoms observed or recorded the LD 50 was considered to be > 16 g/kg bw.
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