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EC number: 607-053-4 | CAS number: 223751-74-4
- 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:
- January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Enzymatic hydrolysis products of Palmaria palmata extract
- EC Number:
- 607-053-4
- Cas Number:
- 223751-74-4
- IUPAC Name:
- Enzymatic hydrolysis products of Palmaria palmata extract
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Salmonella typhimurium
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 ( rat liver microsome fraction)
- Test concentrations with justification for top dose:
- Dose per plate: 5 μL, 1.5 μL, 0.5 μL, 0.15 μL, 0.05 μL with and without S9-mix in TA 98, TA 100, TA 102, TA 1535 , TA 1537
Confirmation test: same concentrations of test item with adding of PBS (-S9) or metabolic activation system mix (+S9) - Vehicle / solvent:
- Water
Justification for choice of solvent/vehicle: The test substance was soluble in water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- absolute negative control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- Without S9
- Untreated negative controls:
- yes
- Remarks:
- absolute negative control
- True negative controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9
- Details on test system and experimental conditions:
- Solubility test: Solubility was assessed :
Liquid: dilutions: 100%, 30%, 10%, 3%, 1%
Solid (100µl/plate): 50 mg/mL, 16.67 mg/mL, 5 mg/mL, 1.67 mg/mL, 0.5 mg/mL
Cytotoxicity test: A potential cytotoxicity effect of the test item that would interfere in the results was ruled out with the following test: 5 concentrations and a negative control of test item were tested in
Salmonella typhimurium TA100. The test item was mixed with top agar containing 2.5 mM Histidine/Biotin. The solution was then added to a plate containing mineral agar and incubated at 37°C for 48hours.
Inhibition of growth by the test item suggests a cytotoxicity activity. A cytotoxicity effect at high concentrations only would require lower concentrations of the test item in the main test.
Cytotoxicity activity at lower concentrations could rule out the bacterial reverse mutation test for the evaluation of mutagenicity.
Test performance: Cultures of bacteria were incubated overnight with nutrient broth up to an absorbance (60 nm) of approximately 1.2-1.4 OD. This OD indicates that bacteria are growing in the late exponential or early stationary phase of growth (approx. 10^9 bacteria/ml).
Plates were prepared with minimal agar medium . Medium was mixed and preheated to about 45°C and then poured into the plate and cooled at room temperature.
Each bacterial strain was tested by triplicate, both, in the presence and absence of the metabolic system (S9). The bacterial suspension, the test item and PBS (-S9) or metabolic system mix (+S9) were mixed and tempered at about 37°C.
The solution was mixed with top agar and poured over the minimal agar medium plate. The top agar was allowed to solidify at room temperature before final incubation.
Plates were incubated at about 37°C for about 48 hours. The number of colonies per plate was then counted.
Two controls were included in the experiment:
- negative control: absolute negative control
- positives control: control mutagens were used for each strain as detailled above - Rationale for test conditions:
- Confirmation test:
An independant confirmation test was performed with the test item. After the bacterial suspension, the test item and PSB (-S9) or metabolic activation system mix (+S9) were mixed and the mixture was be incubated at about 37°C for about 20 minutes. Thereafter, the study was performed in the same was as the first test (described behind) - Evaluation criteria:
- The number of colonies per plate was counted with an automatic colony counter. Data are presented as the number of colonies present per plate (mean +/- standard deviation). The ratio R is calculated as follows: R = number of revertant colonies in the presence of the test item / Number of revertant colonies in the absence of the test item.
Several criteria are used for determining a positive result: a dose-response in the range tested and/or a reproductible increase at one or more concentrations in the number of revertant colonies per plates in at least one strain with or without metabolic activation system.
Positive results from the bacterial reverse mutation test indicate taht a test induces point mutations or readings frame-shifts in the genome of the tested experimental system.
Negative results from the test indicates that under the test conditions, the test item is not mutagenic and pro-mutagenic in the tested species.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA98, TA100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The controls of the test were in accordance with the expected results:
- No cytotoxic effect was observed
- Sterility test showed no contamination during the study
- All positive controls performed showed absolute number of revertant colonies comparable to historical data
- No concentration of the test item showed a biological significant increase (R>=2.5) of the number of revertant either with of without S9 metabolic activation
- No dose response was observed in none of the tested bacterial strains
Applicant's summary and conclusion
- Conclusions:
- The following conclusions can be inferred from the obtained results:
- No test item showed ratios (R) above 2.5 as compared to the negative control, either with or without S9 metabolic activation
- No dose response was observed in none of the tested bacterials strains.
Based on the results obtained in this study, the test item was found NON MUTAGENIC and NON PRO-MUTAGENIC under the test conditions. - Executive summary:
The present bacterial reverse mutation test (AMES test) was performed in order to evaluate the mutagenic potential of the test item.The test was performed in accordance with OECD Guideline 471 for the Testing of Chemical (Bacterial Reverse Mutation Test, Adopted 21st, July 1997) and the TestMethod B13/B14 Of Commission Directive 2000/32/EC.
Suspension of 5 amino-acid requiring strains of Salmonella typhimurim (TA98, TA100, TA102, TA1535, TA 1537) auxotroph for an amino acid, were exposed to the test item in the presence and in the absence of an exogenous metabolic activation system.
After incubation, revertant colonies due to point mutations were counted and compared to the number of spontaneous revertant colonies on solvant control plate (negative control). Similarly, specific standard mutagens were tested and used as positive controls.
Based on the results obtained in this study, the test item was found NON MUTAGENIC and NON PROMUTAGENIC under the test conditions
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