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EC number: - | CAS number: -
- 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:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester
- Cas Number:
- 29358-99-4
- Molecular formula:
- C13H15N3O8
- IUPAC Name:
- L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The starting dose can be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg of L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester per kg body weight to be used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose did not cause mortality for 48 hours and therefore, in a second step, another 3 females were treated at the same dose level.
- Clinical signs:
- No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period at limit dose of 2000 mg/kg body weight was observed. Slight lethargy 30 minutes after administration of test item was seen in Animal No 3, but other adverse reactions during next 24 hours and 14-days observation period were not reported. Summary results of clinical observations are presented in Table 1.
- Body weight:
- The body weights of all animals increased during the study.
- Gross pathology:
- All animals were necropsied. No visible pathological findings were observed in animals dosed with 2000 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The purpose of the study was to evaluate the potential toxic effect of the test item “L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester” when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.
In the first step, one group of 3 females was dosed. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. The test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. Slight lethargy was observed in Animal No 3 ½ an hour after administration, but was not seen after 1 hour and later. During necropsy we did not observe any macroscopic findings in all Animals at this dose level. The LD50 of the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is classified in GHS Category 5 – Unclassified. Limit test with dose of 5000 mg/kg body weight was not conducted. - Executive summary:
The test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. Slight lethargy was observed in Animal No 3 ½ an hour after administration, but was not seen after 1 hour and later. During necropsy no macroscopic findings were observed in all Animals at this dose level. The body weights of all animals increased in normal range during the study.
The LD50 of the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is classified in GHS Category 5- Unclassified. Limit test with dose of 5000 mg/kg was not conducted.
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