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EC number: 257-440-3 | CAS number: 51812-80-7
- 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
Ceraphyl 60 was tested for mutagenicity potential using the Salmonella auxotrophe strains as described by Ames et al. in Mutation Research, 113 (1983) pp. 173-215.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Version / remarks:
- Not applicable
- Deviations:
- no
- Principles of method if other than guideline:
- Test procedure based on "Revised methods for the Salmonella mutagenicity Test" by Dorothy M, Maron and Bruce N. Ames. Mutation Research 113 (1983): 173-215
- GLP compliance:
- yes
- Remarks:
- US FDA
- Type of assay:
- bacterial forward mutation assay
- Specific details on test material used for the study:
- Identity: Ceraphyl 60, Lot #7452.
Composition:Quaternium 22 CAS# 51812-80-7 in Water CAS# 7732-18-5
Description of test Material: Clear yellow oily liquid
Quantity of Test Material: 245 ml in a glass bottle with plastic lid
Storage Conditions: room temperature - Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix from rat liver
- Test concentrations with justification for top dose:
- Without activation: 10 µg
With activation: Three dose levels: 0.1 µg, 1.0 µg and 10 µg - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Media
(a} Minimal agar medium for mutagenicity
(b) Top Agar Medium
{c) Nutrient Broth
Post-Mitocondrial Supernatant Fraction:
(a) Induction of Rat Liver Enzymes using mMale rats (200 grams. each) for tne inductfon with a single intraperitoneal injection of Aroclor 1254 at a dosage of 500 mg/kg five days before sacrifice.
(b) Preparation of Liver Homogenate: After weighing, livers were transferred to beakers containing 3 ml of 0.15 M KCl per gram of wet liver. Livers were minced and then centrifuged for 10 minutes at 9000 g.
(c) Storage: The S-9 fraction was distributed in 2 ml portions in small vials, quickly frozen and stored at -80 c.
DURATION
- Exposure duration: incubation at 37 dC for 72 hours
THE MUTAGENICITY TEST:
conducted by adding each level of test chemical to tubes containing 0.1 ml of tester strains and 2 ml of top agar (45 DC}, The tube contents were mixed and poured on minimal agar plates , in duplicate. - Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- not applicable
- 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:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Ceraphyl 60 was tested for mutagenicity potential using the Salmonella auxotrophe strains as described by Ames et al. in Mutation Research, 113 (1983) pp. 173-215. The results of this series of tests indicate that the material does not have mutagenic potential.
Reference
Resuls of the spot-test and mutagenicity testing without activation | |||
TA97 | TA98 | TA100 | |
10µg A | - | - | - |
10µg B | - | - | - |
Negative Control A | - | - | - |
Negative Control B | - | - | - |
Positive control A | + | ++ | +++ |
Positive control B | + | ++ | ++ |
Resuls of mutagenicity testing with S9-activation | ||||||
20µl - S9 | 50µl - S9 | |||||
Ceraphyl 60 | TA97 | TA98 | TA100 | TA97 | TA98 | TA100 |
0.1µg A | 12 | 21 | 19 | 21 | 11 | 25 |
0.1µg B | 17 | 16 | 28 | 16 | 9 | 23 |
1.0µg A | 16 | 14 | 30 | 36 | 20 | 24 |
1.0µg B | 19 | 19 | 22 | 27 | 23 | 27 |
10µg A | 33 | 17 | 28 | 19 | 29 | 10 |
10µg B | 18 | 21 | 19 | 8 | 21 | 33 |
Negative Control A | 14 | 20 | 17 | 24 | 20 | 19 |
Negative Control B | 24 | 26 | 19 | 26 | 12 | 12 |
Positive control A | 2110 | 1960 | 2004 | 2836 | 2450 | 1990 |
Positive control B | 2624 | 2228 | 1898 | 2540 | 2244 | 2460 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The results of this AMES test indicate that the material does not have mutagenic potential.
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