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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
A number of tests are available that assess the potential of L-Tyrosine to cause genetic toxicity.
The key study is a recent Ames test in accordance with OECD and GLP criteria.
Additionally, a number of supporting studies were found in the published literature. It concerns two gene mutation tests in bacteria (a WP2 Mutoxitest and a Lac+ mutagenesis test), and two chromosome aberration type tests (a Sister Chromatic Exchange test and a DAU-DNA alkaline unwinding test).
All tests were found to be negative. Hence, L-Tyrosine is not genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017.07.28 - 2017.09.24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5575 - Mitotic Gene Conversion in Saccharomyces cerevisiae
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
- no precipitation of the test item was observed in any tester strain used in experiment I and II (with
and without metabolic activation)
- no toxic effects of the test item were noted in any of the five tester strains used up to the highest
dose group evaluated (with and without metabolic activation) in experiment I and II - Vehicle / solvent:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-AA; 2-aminoanthracene
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD; 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation) in Experiment I and pre-incubation in
Experiment II.
DURATION
- Exposure duration: 48h at 37°C
NUMBER OF REPLICATIONS: 3
ACCEPTANCE CRITERIA:
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100 and TA 102)
- the negative control plates (A. dest.) with and without S9 mix are within the historical control data
range of the test facility
- corresponding background growth on solvent control, negative control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate
- at least five different concentrations of each tester strain are analyzable - Rationale for test conditions:
- according to OECD GL 471
- Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean
values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the
interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible
biologically relevant positive response at any of the dose groups is considered to be non-mutagenic
in this system. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the
interpretation of results, a statistical evaluation of the results is not regarded as necessary. - Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535 pSK1002
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - no precipitation of the test item was observed in any tester strain used in experiment I and II (with
and without metabolic activation)
- no toxic effects of the test item were noted in any of the five tester strains used up to the highest
dose group evaluated (with and without metabolic activation) in experiment I and II - Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, L-Tyrosine did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, L-Tyrosine is considered to be non-mutagenic in this bacterial reverse mutation assay.
- 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 potential of the test item L-Tyrosine to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 was assessed according to OECD TG 471 and in compliance to GLP.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments: 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with L-Tyrosine at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, L-Tyrosine did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, L-Tyrosine is considered to be non-mutagenic in this bacterial reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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.
As all in-vitro tests are negative, classification for this endpoint is not required.
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.