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EC number: 604-012-2 | CAS number: 137296-15-2
- 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:
- weight of evidence
- Study period:
- 2005-07-15 to 2005-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-
- EC Number:
- 604-012-2
- Cas Number:
- 137296-15-2
- Molecular formula:
- C3H9O3N
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Ammonium Lactate, PURASAL® NH
- Physical state: not reported
- Analytical purity: not reported
- Lot/batch No.: 0503002615
- Expiration date of the lot/batch: 2007-09-28
- Storage condition of test material: room temperature (20 ± 5 °C) in the dark
- Other: Reception date: 2005-04-01
Method
- Target gene:
- S. typhimurium: Histidine locus
E. coli: Tryptophan locus
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:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary test: 100, 50, 25, 12.5, 6.25 and 3.125 µL/plate (with and without metabolic activation)
Main test: 50, 16.67, 5.56, 1.85, 0.62 and 0.21 µL/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
The solvent used for the test item was distilled water. No solubility tests were done because the sponsor defined the test item as completely soluble in water. The maximum concentration of 100 µL/plate, i.e. undiluted substance, was used for the performance of the preliminary test. The subsequent concentrations were prepared by 1/2 dilutions with sterile distilled water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9, 1 µg/plate, all strains used
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, 1 µg/plate, TA 1535 and TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9, 50 µg/plate, TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9, 1 µg/plate, E. coli WP2
- Details on test system and experimental conditions:
- PREINCUBATION METHOD:
The amount of 0.1 mL of the test item/test solvent was preincubated with 0.1 mL of the test strain culture and 0.5 mL of sterile buffer or metabolic activation system for 20 minutes at 37 ± 1 °C prior to mixing with 2.0 mL of the overlay agar and pouring onto the surface of a minimal agar plate. During pre-incubation the tubes were aired using a shaker.
This overlay melted at 45 ± 1 °C contained a sterile solution of 0.5 mM L-histidine/0.5 mM biotin in the proportion of 1:10 for Salmonella typhimurium and 0.25 mL of a sterile solution of tryptophan and 5 mL of nutrient broth for every 100 mL of top agar for Escherichia coli. The metabolising enzymes in the S-9 mixture are not stable at 45 °C and so the contents of the test tubes were mixed rapidly in a rotamixer and poured into plates containing a base layer of minimal agar. The added agar was allowed to settle down and the plates were incubated at 37 ± 1 °C for 48-72 hours. After this incubation period, the number of revertant colonies that had grown on each plate was counted. The experiment was repeated on another day using fresh bacterial cultures. - Evaluation criteria:
- According to OECD 471
- Statistics:
- The comparisons between the results for the standard products and the control were made using Student's t-test. The statistical comparison of the different test-item concentrations was carried out, for all the bacterial strains, both with and without metabolic activation, using a one-way analysis of variance with a level of significance of p < 0.05.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: see box "additional information on results"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The maximum concentration of 100 µL/plate, i.e. undiluted substance, was used for the performance of the preliminary test. At the concentration of 100 µL/plate a slight decrease was observed in the number of revertants in strain TA-100 without S-9. In accordance with the OECD, which suggests 5 µL/plate as the high concentration for liquids, lower concentration were tested in the main test. 50 µL/plate was taken as the maximum concentration and 1/3 dilutions were prepared.
RESULTS (Experiment 1):
Positive controls: All the bacterial strains responded positively.
Negative controls: Normal values (within the range of historical data for negative controls) were obtained in the revertant colony counts on all the dishes treated only with the solvent.
Test item: The test item was toxic for TA-100 with and without S-9 and for TA-1535 with S-9 at the concentration of 50 µL/plate. No mutagenic response was observed in any of the tested strains, with or without S-9.
RESULTS (Experiment 2):
Positive controls: All the bacterial strains responded positively.
Negative controls: Normal values (within the range of historical data for negative controls) were obtained in the revertant colony counts on all the dishes treated only with the solvent. The mean of the control for the strain TA-1537 without S-9 fell slightly above the upper limit established by historical data although it fell within the range given in literature.
Test item: The test item was toxic for TA-100 without S-9 and for TA-1535 with S-9 at the concentration of 50 µL/plate.
No mutagenic response was observed in any of the tested strains, either with or without S-9.
Any other information on results incl. tables
Table 2: Summary of the results obtained with the test item (experiment 1) | |||||||||
Mean revertants per plate (µL/plate) | |||||||||
Test strain | % S-9 | Control | 0.21 | 0.62 | 1.85 | 5.56 | 16.67 | 50 | |
TA 1535 | 0.0 | 21.7 | 20.3 | 21.7 | 20.7 | 20.3 | 22.3 | 21.0 | |
TA 1537 | 0.0 | 19.7 | 19.0 | 19.0 | 19.0 | 18.7 | 20.7 | 19.3 | |
TA 98 | 0.0 | 31.0 | 31.0 | 31.0 | 30.3 | 30.7 | 31.7 | 32.0 | |
TA 100 | 0.0 | 133.3 | 132.3 | 132.7 | 131.0 | 133.0 | 132.7 | - | |
E. coli WP2 | 0.0 | 143.3 | 143.0 | 142.3 | 141.3 | 142.3 | 141.0 | 141.7 | |
TA 1535 | 10.0 | 21.0 | 20.0 | 20.7 | 19.0 | 20.7 | 20.7 | - | |
TA 1537 | 10.0 | 20.3 | 19.0 | 19.3 | 18.7 | 20.7 | 19.7 | 19.7 | |
TA 98 | 10.0 | 35.7 | 36.3 | 36.7 | 35.3 | 35.7 | 36.0 | 37.3 | |
TA 100 | 10.0 | 120.7 | 121.3 | 119.3 | 120.7 | 119.7 | 120.0 | - | |
E. coli WP2 | 10.0 | 143.0 | 141.7 | 142.3 | 142.0 | 142.0 | 141.3 | 142.0 |
Table 3: Summary of the results obtained with the test item (experiment 2) | |||||||||
Mean revertants per plate (µL/plate) | |||||||||
Test strain | % S-9 | Control | 0.21 | 0.62 | 1.85 | 5.56 | 16.67 | 50 | |
TA 1535 | 0 | 25.0 | 24.3 | 22.3 | 25.3 | 23.3 | 22.0 | 23.3 | |
TA 1537 | 0 | 24.0 | 22.3 | 25.0 | 22.3 | 25.0 | 23.3 | 22.7 | |
TA 98 | 0 | 29.7 | 30.0 | 32.0 | 29.0 | 28.7 | 28.7 | 28.7 | |
TA 100 | 0 | 140.3 | 140.7 | 140.3 | 139.0 | 139.7 | 141.0 | - | |
E. coli WP2 | 0 | 140.0 | 139.7 | 140.3 | 140.0 | 141.0 | 141.0 | 140.0 | |
TA 1535 | 10 | 22.7 | 22.7 | 21.0 | 21.3 | 20.7 | 22.0 | - | |
TA 1537 | 10 | 25.7 | 25.7 | 25.3 | 26.0 | 26.7 | 26.3 | 25.3 | |
TA 98 | 10 | 32.3 | 34.3 | 33.7 | 34.3 | 33.7 | 32.7 | 33.7 | |
TA 100 | 10 | 141.0 | 142.0 | 140.3 | 140.3 | 140.3 | 141.3 | 141.3 | |
E. coli WP2 | 10 | 141.7 | 141.3 | 140.7 | 140.3 | 141.7 | 140.7 | 141.3 |
Applicant's summary and conclusion
- Conclusions:
- The test item showed no evidence of mutagenic activity in a bacterial reverse mutation assay (OECD 471).
- Executive summary:
In a bacterial reverse mutation assay (according to OECD 471) Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one strain of Escherichia coli (WP2 uvrA) were exposed to the test item at concentrations of 0, 0.21, 0.62, 1.85, 5.56, 16.67 and 50 µL per plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies above background.
This study is classified as acceptable. This study satisfies the requirement of OECD test guideline 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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