Registration Dossier
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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
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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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed publication
- Author:
- n.a.
- Year:
- 1 991
- Bibliographic source:
- n.a.
Materials and methods
- Principles of method if other than guideline:
- No OECD guideline was followed, however after acute dosing the animals were observed for 2 weeks and multiple parameters were assessed.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tyrosine
- EC Number:
- 200-460-4
- EC Name:
- Tyrosine
- Cas Number:
- 60-18-4
- Molecular formula:
- C9H11NO3
- IUPAC Name:
- tyrosine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 250-300g
- Fasting period before study: overnight
- Housing: 2 per stainless steel cage (7 X 7 X 10 in.)
- Diet: ad libitum Purina Rat Chow (5012)
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hr light (0600-1800 hr)/12-hr dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (w/v) methylcellulose, 0.1% (v/v) polysorbate 80 and distilled water
- Details on oral exposure:
- DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 309 mg/kg
618 mg/kg - No. of animals per sex per dose:
- 15 male rats
- Control animals:
- yes
- Remarks:
- 15 vehicle control animals per dose and d-amphetamine as positive control reported elsewhere (Mullenix et al., 1989. Generation of dose-response data using activity measures. / Am. Coll. Toxicol. 8, 185-197)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency behavioral testing: daily
- Blood samples: immediately after behavioral testing
- Euthanisation: overdose pentobarbital
- Behavioral tests: A computer pattern recognition system was used. A control and test rat are placed simultaneously on either side of a clear Plexiglas box separated by a clear partition with small holes. The animals could see and smell each other while they explored the novel environment. Two video cameras at one frame per second were used to monitor and record the rats' spontaneous behavior. The video signals are transferred to a MICRO VAX I and a VAX 11/750 for pattern analysis and behavioral classification of the data. The specific behaviors identified by the computer consist of 5 major body positions: stand, sit, rear, walk, lying down; and eight modifiers: blank (no recognized ac- tivity), groom, head turn, turn, look, smell, sniff, wash face. - Statistics:
- A student's t-test was applied, and a p < 0.05 was required for statistical significance.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 618 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: No significant altered bahavioural effect were observed at any dose. Tyrosine did not affect spontaneous behaviour.
- Gross pathology:
- Not evaluated.
- Other findings:
- - Plasma level: elevated plasma concentrations of tyrosine after dosing
- Positive control: Amphetamine clearly increased the total time the rats engaged in walking, turning, and head turning, and thus influenced the overal behaviour.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not acute toxic and the LD50 is > 618 mg/kg bw.
- Executive summary:
O-phospho-L-tyrosine dissociates in aqueous solutions. As according to REACH regulation only publicly available data has to be provided with the Registration dossier for on-site isolated intermediates in a tonnage band of < 1,000 t/a. Thus, information on the paren compound L-tyrosin is considered relevant and will be used for the registration dossier of O-phospho-L-tyrosine.
In the current study the effect of a single oral administration of a high dose of tyrosine was investigated. More in detail the behavior of the rats was evaluated with a computer pattern recognition system. The study was not according to OECD or GLP, however, the animals were observed for 2 weeks. There were 2 dosing groups, 309 and 618 mg/kg, each containing 15 animals and each group was linked to a control group of 15 animals. Amphetamine was used as positive control.
No animals died and no adverse effects were observed during the course of the study. Amphetamine clearly increased the total time the rats engaged in walking, turning, and head turning, and thus influenced the overal behavior.
No LD50 was determined in the study, however, we can derive it and state that the LD50 is > 618 mg/kg bw.
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.
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