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EC number: 816-146-0 | CAS number: 1016788-34-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21st July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Comission Directive 2002/32/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-[(2-acetamidoacetyl)amino]propanoic acid
- EC Number:
- 816-146-0
- Cas Number:
- 1016788-34-3
- Molecular formula:
- C7H12N2O4
- IUPAC Name:
- 3-[(2-acetamidoacetyl)amino]propanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Commercially available post-mitocondiral fraction S9 from livers of rodents treated with th eenzyme inducing agent Aroclor
- Test concentrations with justification for top dose:
- 5.00 , 3.00, 2.00, 1.00 and 0.20 mg/plate
- Vehicle / solvent:
- milliQ water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoantrhacene (S9+, with metabolic activation)
- Details on test system and experimental conditions:
- The bacterial strains used for the study were grown from controlled Working Banks obtained from Master
Banks (generated in Vivotecnia) in nutrient broth supplemented with the corresponding antibiotics when
required, as follows:
TA98
Nutrient Broth #2 25g/L
Ampicillin 0.025mg/mL
TA100
Nutrient Broth #2 25g/L
Ampicillin 0.025mg/mL
WP2 (pKMl 01 )
Nutrient Broth #2 25g/L
Ampicilin -
TA1535
Nutrient Broth #2 25g/L
Ampicilin -
TA1537
Nutrient Broth #2 25g/L
Ampicilin -
Inoculums were liquid grown overnight up to the late exponential-early stationary phase of growth
(approximately 1.2-1.4 OD at 660nm). This OD indicates that bacteria are growing in the late exponential or
early stationary phase of growth (approximately 1-2x10E9 CFU/mL).
The following types of agar medium were used in the test:
Media Agar Glucose Vogel-Bonner NaCI Histidine Biotin Tryptophan
Minimal agar 1.5% w/v 0.2% w/v 2% v/v - - - -
Top agar Salmonella 0.54% w/v - - 0.45% w/v 0.05mM 0.05mM -
Top agar E.Coli 0.54% w/v - - 0.45% w/v - - 0.05mM - Evaluation criteria:
- The criteria used for determining a positive result take into account a dose-response effect in the range
tested andlor a reproducible increase at one or more concentrations in the number of revertant colonies per
plate in at least one strain with or without metabolic activation system.
A result is considered positive whenever the number of revertants of the test item treated plates is increased
when compared to the solvent treated plates according to the following criteria:
species strain criteria
S.typhimurium TA98 2 fold
S.typhimurium TA100 2 fold
S. typhimurium TA102 2 fold
S.typhimurium TA1535 3 fold
S.typhimurium TA1537 3 fold
E.coli WM'2(pKM101 ) 2 fold
Biological relevance of the results was also considered.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertant colonies per plate was counted and recorded by an automatic colony counter.
Average plate counts was presented with the mean and the standard deviation for each set of triplicates per
test item concentration and was used to calculate the ratio of colonies per exposed plate compared to the
corresponding negative control.
Colony counting evaluation (R value)
None of the concentrations assayed for the test item showed an increase in the R value either with or without
S9 metabolic activation regardless of the procedure.
No growih was observed in the bacteria strain E. coli WP2 without metabolic activation system under
preincubation procedure.
This condition and E. coli WP2 without metabolic activation system under direct incorporation procedure
were repeated in order to confirm the obtained results.
The decrease in the R value of the bacteria strain E. coli WP2 without metabolic activation system under
preincubation procedure was alsoobserved in the repetition.
Dose response evaluation
No dose response for the test item Ac-Gly-beta-Ala-OH was observed in any of the tested bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- The substance showed no mutagenic effects in the performed Bacterial Reverse Mutation test (OECD 471), both with and without metabolic activation.
Therefore, the substance is considered to be non mutagenic and non promutagenic. - Executive summary:
The bacterial reverse mutation test (Ames test) assesses the mutagenic or promutagenic potential of the test
item Acetyl glycyl beta.alanine in the several bacterial strains.
The test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial
Reverse Mutation Test. Adopted 21st July 1997) and the test Method B13/B14 of Commission Directive
2000/32/EC.
No cytotoxic activity was observed at a test item concentration of 50.0mg/mL.
Five test item doses ranged between 5.00 and 0.2 mg/plate were assayed. None of the concentrations
assayed for the test item showed an increase in the R value either with or without S9 metabolic activation
regardless of the procedure.
No dose response for the test item acetyl glycil beta-alanine was observed in any of the tested bacterial strains.
Based on the results obtained in this study, it can be concluded that the test item does not induce point
mutations or frame-shifts in the genome of the bacterial strains with or without metabolic activation
regardless of the procedure.
Therefore, the test item Acetyl glycyl beta-alanine is considered to be NON MUTAGENIC / NON PROMUTAGENIC
under the experimental conditions assayed.
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