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EC number: 458-930-1 | 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 0.1 mL volume additions were used for plate-incorporation treatment and 0.05 mL volume additions were used for pre-incubation treatments
Final concentration (µg/plate);
78.13
156.3
312.5
625
1250
2500
5000 - Vehicle / solvent:
- Ethanol
- Untreated negative controls:
- yes
- Remarks:
- Ethanol
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Toxicity Range-Finder Experiment
Triplicate plates with and without S9 mix were used. Negative (solvent) and positive controls were included in quintuplicate and triplicate, respectively. An initial Range Finder test was performed using TA100 strain only. Ceraphyl 55 was tested at 1.6, 40, 200, 100, 5000 µg/plate with and without metabolic activation (positive and negative controls included). The plating was achieved by adding 2.5 mL molten agar at 46±1C:
- 0.1 mL bacterial culture
- 0.1 mL test article solution
- 0.5 mL 10% S-9 mix or buffer solution
The culture were mixed and placed on agar plates. The plates were incubated at 37±1C in the dark for 3 days and then checked for revertant colonies.
Mutation Experiment
Two experiments were conducted using four strains of Salmonella Typhimurium and one strain Escherichia coli, with and without S9. The first experiment showed negative results; therefore the second experiment included a pre-incubation step. The test article (or control solution), bacteria and S9 mix were mixed together and incubated for 1 hour at 37±1C with shaking, before addition of 2.5 molten agar at 43±1C. Plating followed the normal procedure. In the second experiment, the volume addition in the pre-incubation treatments was reduced to 0.05 mL due to the solvent used (Ethanol).
Ethanol and other organic solvents are toxic at 0.1 mL, therefore 0.05 mL was chosen to minimise the possibility of toxicity.
Experiment 2 was repeated using WP2 uvrA strain with and without S9. - Evaluation criteria:
- The assay was considered valid if:
1. The mean negative control counts fell within the normal ranges (Laboratory database)
2. The positive control chemicals induced clear increase in revertant numbers confirming discrimination between different strains, and an active S9 preparation
3. No more than 5% of the plates were lost due to contamination or other events.
4. A dose related increase in revertant numbers was observed that was at least two times the mean negative control counts for strain TA98, TA100 and WP2 uvrA and at least three times the mean negative control counts for strain TA1535 and TA1537.
5. The positive control has to be reproducible. - Statistics:
- Mean and standard deviations were calculated from all individual plates of all experiments.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Additional information on results:
- Precipitation of the test article was observed following treatment of the two highest doses, both with and without S9.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test article Ceraphyl 55 does not induce mutation in Salmonella Typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli ( WP2 uvrA). - Executive summary:
The objective of the study was to evaluate the mutagenic activity of the test material Ceraphyl 55 using four strains of Salmonella Typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli ( WP2 uvrA), both with and without S9. An initial range finder toxicity study was performed using only TA100 strain. No evidence of toxicity was observed at concentration of 1.6, 8, 40, 200, 1000 and 5000 µg/plate. Precipitation was observed at the two highest doses, with or without S9. The Experiment 1 included all strains and the same doses tested in the range finder test and as previously, no evidence of toxicity was observed at concentration of 1.6, 8, 40, 200, 1000 and 5000µ/plate. Precipitation of the test material was observed at the highest dose, with or without S9. The Experiment 2 was performed using all strains with and without S9 and a dose range from 78.13 to 5000 µg/plate. A pre-incubation step was included to increase the range of mutagenic chemicals able to induce positive responses in this test system. No evidence of toxicity was observed. Test material precipitation was observed at the two highest doses, both with or without S9. The negative and positive controls were included all gave results that fell within the acceptable range. The result of the test shows no increase in revertant numbers in any strain treatment with or without metabolic activation. In conclusion, Ceraphyl 55 is not mutagenic in Salmonella Typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli ( WP2 uvrA), both with and without S9.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Four in vitro genotoxicity studies are available on the test material Ceraphyl 55.
The test material Ceraphyl 55 was evaluated in the Ames/Salmonella Plate Incorporation Assay to determine its ability to induce reverse mutations in 5 strains of Salmonella Typhimurium (Pharmakon, 1987). A pre-test was conducted by treating duplicate cultures of strains TA1538 and TA100 at Ceraphyl 55 dose level of 50.0, 167, 500, 1670 ug/plate. None of the selected doses displayed toxicity. Inhibited growth was observed at dose level of 5000 ug/plate. At dose level of ≥ 500 the test article coalesced from solution upon addition to top agar. Based on these results, the test material was tested in triplicate cultures under the same pre-test condition at doses of 50.0, 167, 500, 1670, 3330 or 5000 ug/plate
, with and without S9. An extra dose was tested in the event of unacceptable high toxicity at the highest dose level. All positive and negative controls were within acceptable limits. The results of test showed that Ceraphyl 55 did not induce reverse mutations in Ames/Salmonella test, therefore it is considered to be not genotoxic.
The objective of the second study was to evaluate the mutagenic activity of the test material Ceraphyl 55 using four strains of Salmonella Typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli ( WP2 uvrA), both with and without S9 (Covance, 2004). An initial Range Finder Toxicity was performed using only TA100 strain. No evidence of toxicity was observed at concentration of 1.6, 8, 40, 200, 1000 and 5000 µg/plate. Precipitation of the test material was observed at the last two highest doses, with or without S9. The Experiment 1 included all strains and the same doses tested in the Range Finder test. As in the range-finder study, no evidence of toxicity was observed at concentrations of 1.6, 8, 40, 200, 1000 and 5000µg/plate. Precipitation of the test material was observed at the highest dose, with or without S9. The Experiment 2 was performed using all strains with and without S9 and a dose range from 78.13 to 5000 µ/plate. A pre-incubation step was also included to increase the range of mutagenic chemicals able to induce positive response in this test system. No evidence of toxicity was observed. Test material precipitation was observed at the last two highest doses, with or without S9. The result for the negative and positive control materials fell within the acceptable range. The result of the test shows no increase in revertant numbers in any strain treatment with or without metabolic activation. In conclusion, Ceraphyl 55 was not mutagenic test material in Salmonella Typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli ( WP2 uvrA), both with and without S9.
In addition, a test on Chinese hamster ovary (CHO) cells was conducted by Covance (2004) in order to investigate the potential to induce chromosome aberrations. Two experiments were performed. In the first experiment, cells were treated for three hours with and without metabolic activation (S-9) followed by a 17- hours recovery period to harvest (3 +17). The highest concentration chosen for analyses was 41.231µg/mL in the absence of S-9 and 600µg/mL in the presence of S-9. The highest concentration, 600.0 µg/mL was in excess of the solubility limit of the test article in culture medium. In the second experiment, cells were treated in the absence of S-9 continuously for 20 hours and in the presence of S-9 for 3 hours followed by 17 -hour recovery period prior to harvest (3 +17). The highest concentration chosen for analyses was 32.77µg/mL in the absence of S-9 and 600µg/mL in the presence of S-9. Solvent and positive controls were included in the test system in both experiments. The results of the two experiments showed no increases in the frequency of cells with numerical aberration, which exceed the historical negative control range, both with and without metabolic activation. In conclusion, Ceraphyl 55 did not induce chromosome aberration in cultured Chinese hamster ovary (CHO) cells when tested up to its limit of cytotoxicity or in excess of the solubility limit.
A fourth experiment was conducted by BioReliance Corporation (2013). Ceraphyl 55was investigatedfor its ability to induce forward mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus (hprt) of Chinese hamster ovary (CHO) cells, in the presence and absence of a metabolic activation system (S9).
A preliminary solubility testing was conducted using concentrations of 8.30, 16.6, 33.2, 66.4, 133, 266, 531, 1060, 2130 and 4250 µg/mL with and without S9 (the maximum concentration evaluated approximated the10 mM limit doseforthisassay). All test article concentrations, as well as the vehicle control, were evaluated in single cultures. The result showed thatCeraphyl 55 was freely soluble at all concentrations evaluated, and little or no cytotoxicity was observed.
The concentrations used in the definitive mutagenicity assay were 531, 1060, 2130, 3190 and 4250 µg/mL with and without S9. All test substance concentrations, the positive and vehicle controls, were evaluated in duplicate cultures. Ceraphyl 55 was found to be incompletely soluble at the beginning of treatmentat a concentration of 4250 µg/mL, but became freely soluble by the end of treatment. Results showed no significant increases in mutant frequency, as compared to the concurrent vehicle controls at any concentration tested with or without S9 (p > 0.05). As expect, the positive controls induced significant increases in mutant frequency (p < 0.01).
An independent confirmatory assay was conducted at concentrations of 531, 1060, 2130, 3190 and 4250 µg/mL with and without S9. All test article concentrations, positive and vehicle controls, were tested in duplicate cultures. The results showed that Ceraphyl 55 was freely soluble at all concentrations evaluated, and little or no cytotoxicity was observed (average adjusted relative survivals at 4250 µg/mL were 102.0% and 74.6% with and without S9, respectively). No significant increases in mutant frequency, as compared to the concurrent vehicle controls, were observed at any concentration tested with or without S9 (p > 0.05; those cultures treated at a concentration of 2130 µg/mL with S9 were excluded from statistical evaluation due to loss of one of the replicate cultures). The positive controls induced significant increases in mutant frequency (p < 0.01).
All positive and vehicle control values were within acceptable ranges. All criteria for a valid assay were met. In conclusion, the test materialCeraphyl 55 resulted negative in theIn Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures under the condition of this study.
Justification for classification or non-classification
Ceraphyl 55 are not considered mutagenic and do not meet the criteria for classification and labelling under CLP EU Regulation 1272/2008.
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.
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