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EC number: 274-356-2 | CAS number: 70161-20-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Ames Salmonella/mammalian-microsome testing of peptides and peptide synthesis reagents
- Author:
- Jane S. Allen and Jennifer Panfili
- Year:
- 1 986
- Bibliographic source:
- Mutation Research, 170 (1986) 23-29
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Salmonella/reverse mutation assay was performed to evaluate the mutagenic potential of the test material 1-Hydroxybenzotriazole monohydrate.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-Phenylalaninamide, L-tryptophyl-L-methionyl-L-alpha-aspartyl-
- Cas Number:
- 1947-37-1
- Molecular formula:
- C37H42N6O8S
- IUPAC Name:
- L-Phenylalaninamide, L-tryptophyl-L-methionyl-L-alpha-aspartyl-
- Details on test material:
- - Name of test material: L-TryptophyI-L-methionyI-L-aspartyl-L-phenylalaninamide
- Molecular Formula: C37H42N6O8S
- Molecular Weight: 596.7054 g/mol
- Substance type: Organic
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: L-TryptophyI-L-methionyI-L-aspartyl-L-phenylalaninamide (TMAP)
- Molecular Formula: C37H42N6O8S
- Molecular Weight: 596.7054 g/mol
- Substance type: Organic
- Purity: No data available
- Impurities (identity and concentrations): No data available
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared from aroclor 1254-induced male Sprague-Dawley rat livers
- Test concentrations with justification for top dose:
- With S9:
TA1535/ TA1537/ TA98: 0, 100, 500, 1000, or 5000 µg/plate
TA100: 0, 100, 500, 1000, 3000, 4000 or 5000 µg/plate
Without S9
TA1535/ TA1537/ TA98: 0, 100, 500, 1000, or 5000 µg/plate
TA100: 0, 100, 500, 1000, 1250, 2500, 4000 or 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: The chemical was soluble in water.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (TA100, TA1535; without S9), 2-aminoanthracene (2-AA) (All strains, with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Each compound was tested at least twice using duplicate plates per dose level.
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Toxicity was estimated by examining background bacterial lawns using a stereoscope and the mean number of revertants were noted
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: No data available - Rationale for test conditions:
- No data available
- Evaluation criteria:
- Increase in the number of revertants/plates
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks:
- Mean numbers of revertants per plate determined from all positive control test plates in the presence and absence of S9 were 1535 and 1055 for TA100, 183 and 1190 for TA1535, 175 and 322 for TA1537, and 1137 and 959 for TA98, respectively.
- Additional information on results:
- No data
- Remarks on result:
- other: no mutagenic potential
Any other information on results incl. tables
Table: AMES TEST RESULTS FOR PEPTIDE SYNTHESIS REAGENTS USING S9
Strain |
Amount tested (µg/plate) |
Mean number of colonies per plate |
TA1535 |
5000 |
12 |
1000 |
12 |
|
500 |
13 |
|
100 |
15 |
|
0 |
15 |
|
TA1537 |
5000 |
7 |
1000 |
9 |
|
500 |
9 |
|
100 |
6 |
|
0 |
8 |
|
TA98 |
5000 |
18 |
1000 |
18 |
|
500 |
19 |
|
100 |
23 |
|
0 |
27 |
|
TA100 |
5000 |
111 |
4000 |
- |
|
3000 |
- |
|
1000 |
95 |
|
500 |
92 |
|
100 |
87 |
|
0 |
99 |
Table: AMES TEST RESULTS FOR PEPTIDE SYNTHESIS REAGENTS WITHOUT S9
Strain |
Amount tested (µg/plate) |
Mean number of colonies per plate |
TA1535 |
5000 |
20 |
1000 |
18 |
|
500 |
16 |
|
100 |
19 |
|
0 |
15 |
|
TA1537 |
5000 |
4 |
1000 |
5 |
|
500 |
6 |
|
100 |
5 |
|
0 |
5 |
|
TA98 |
5000 |
7 |
1000 |
15 |
|
500 |
16 |
|
100 |
12 |
|
0 |
12 |
|
TA100 |
5000 |
101 |
4000 |
104 |
|
2500 |
86 |
|
1250 |
84 |
|
1000 |
90 |
|
500 |
- |
|
100 |
- |
|
0 |
87 |
Applicant's summary and conclusion
- Conclusions:
- L-TryptophyI-L-methionyI-L-aspartyl-L-phenylalaninamide (TMAP) did not show any mutagenic activity at concentrations up to 5000 μg/plate in S.typhimurium strains TA1535, TA1537, TA98, TA100 in the presence and absence of S9 metabolic activation system and hence, according to CLP criteria, it can be concluded that L-TryptophyI-L-methionyI-L- aspartyl-L-phenylalaninamide (TMAP) is non genotoxic.
- Executive summary:
The Ames Salmonella/mammalian-microsome assay was used to evaluate the bacterial mutagenicity of L-TryptophyI-L-methionyI-L-aspartyl-L-phenylalaninamide (TMAP), a chemical reagent used in peptide synthesis. The study was performed using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 in the presence and absence of S9 metabolic activation system. Plate incorporation assay was performed and the plates were incubated for 2 days. The plates were observed for a dose depnedent increase in the number of revertants/plate. Two replicates per dose level and concurrent positive and solvent controls were used. Each assay was performed at least twice. L-TryptophyI-L-methionyI-L-aspartyl-L-phenylalaninamide (TMAP) did not show any mutagenic activity at concentrations up to 5000 μg/plate in S.typhimurium strains TA1535, TA1537, TA98, TA100 in the presence and absence of S9 metabolic activation system and hence, according to CLP criteria, it can be concluded that L-TryptophyI-L-methionyI-L- aspartyl-L-phenylalaninamide (TMAP) is non genotoxic.
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