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EC number: 700-155-0 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 13 June 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- adapted
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- corn oil, peroxidised
- IUPAC Name:
- corn oil, peroxidised
Constituent 1
Method
Species / strainopen allclose all
- 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
- Metabolic activation system:
- enzyme fraction S9 induced in the male Sprague-Dawley rat by administation of Aroclor 1254
- Test concentrations with justification for top dose:
- Study 1: extract tested pure (all strains), and diluted at 50% and 25% (only TA100)
Study 2: extract tested pure (all strains) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 0.9% sodium chloride solution (0.9% NaCl) and 96% ethanol (extraction solvents)
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9 mix: 2-nitrofluorene (TA98), sodium azide (TA100, TA1535), 9-aminoacridine (TA1537), methylmethane sulfonate (E.coli) // With S9 mix: 2-anthramine (TA98, TA100, TA1535, E.coli), benzo[a]pyrene (TA1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATES: triplicates
EXTRACTION CONDITIONS:
- Extraction vehicles: 0.9% sodium chloride and 96% ethanol
- Duration: 72 +/- 2 hours with agitation
- Ratio test article/vehicle: 0.2 g/mL for the 0.9% NaCl extracts (study 1 & 2) and 96% ethanol extracts (study 1), 0.4 g/mL for the 96% ethanol extracts (study 2)
- Temperature: 37°C +/- 1°C
- Aspect of the extract/condition of use: after extraction, the extracts were cooled to room temperature, vigourously shaken, decanted and used immediately - Evaluation criteria:
- For each strain of bacteria used and for each concentration of the test article extracts, in the presence or absence of metabolic activation, the mean number of colonies in the dishes and the standard deviation was calculated.
After having confirmed the conformity of the controls, an evaluation of the data obtained in the presence of the test article extracts was performed according to the following scale:
Toxic effect:
- Non-significant results: if the number of colonies apparent in the presence of the test article extracts or these dilutions was greater than the half of the number of colonies apparent in the negative control.
- Significant results: if the number of colonies apparent in presence of the test article extracts or these dilutions was less or equal to half of the number of colonies apparent in the negative control.
Mutagenic effect:
- Non-significant results: if the number of colonies apparent in the presence of the test article extracts or these dilutions was less than twice the number of colonies apparent in the negative control.
- Significant results: if the number of colonies apparent in presence of the test article extracts or these dilutions was greater than or equal to twice the number of colonies apparent in the negative control. - Statistics:
- not applicable
Results and discussion
Test resultsopen allclose all
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- All the controls were in conformity with the requirements.
The values of the negative controls were in conformity with the acceptation requirements.
Standard mutagen substances tested on each strain induced a significant increase in the number of revertant colonies.
Toxic effect:
No value obtained with the test article extracted in 0.9% NaCl and in 96% ethanol was less or equal to half of the value obtained in the presence of negative control, with or without metabolic activation system.
Mutagenic effect:
No value obtained with the test article extracted in 0.9% NaCl and in 96% ethanol was greater than or equal to twice the value obtained in the presence of negative control, with or without metabolic activation system.
Precipitate: no. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Study 1 (0.9% NaCl extract, mean± standard deviation)
|
|
TA 100 |
TA 98 |
TA 1535 |
TA 1537 |
WP2 uvrA |
Without S9 mix |
SR |
126±9 |
38± 7 |
32± 3 |
17± 7 |
46± 5 |
Negative control |
109± 4 |
35± 3 |
32± 6 |
19± 3 |
39± 10 |
|
Test article 100% |
148± 9 |
51± 3 |
33± 11 |
19± 2 |
47± 5 |
|
Test article 50% |
145± 27 |
|
|
|
|
|
Test article 25% |
151 ± 26 |
|
|
|
|
|
Test article 10% |
137± 12 |
|
|
|
|
|
Test article 1% |
127± 11 |
|
|
|
|
|
Positive control |
604± 42 |
782± 28 |
579± 26 |
804± 13 |
526± 42 |
|
With S9 mix |
SR |
159± 20 |
62± 3 |
25± 5 |
19± 5 |
50± 5 |
Negative control |
152± 6 |
51± 9 |
22± 1 |
21± 3 |
54± 7 |
|
Test article 100% |
170± 5 |
62± 3 |
21± 7 |
21± 0 |
53± 5 |
|
Test article 50% |
162± 11 |
|
|
|
|
|
Test article 25% |
146± 9 |
|
|
|
|
|
Test article 10% |
166± 15 |
|
|
|
|
|
Test article 1% |
134±16 |
|
|
|
|
|
Positive control |
1093± 54 |
2260± 172 |
586± 28 |
309± 38 |
466± 16 |
SR = Spontaneous Revertants
Table 2: Study 1 (96% ethanol extract, mean± standard deviation)
|
|
TA 100 |
TA 98 |
TA 1535 |
TA 1537 |
WP2 uvrA |
Without S9 mix |
SR |
126± 9 |
38± 7 |
32± 3 |
17± 7 |
46± 5 |
Negative control |
117± 9 |
58± 5 |
21± 9 |
14± 4 |
50± 2 |
|
Test article 100% |
139± 10 |
56± 12 |
31± 2 |
12± 3 |
48± 5 |
|
Test article 50% |
109± 5 |
|
|
|
|
|
Test article 25% |
140± 23 |
|
|
|
|
|
Test article 10% |
111± 6 |
|
|
|
|
|
Test article 1% |
110± 14 |
|
|
|
|
|
Positive control |
604± 42 |
782± 28 |
579± 26 |
804±13 |
526± 42 |
|
With S9 mix |
SR |
159± 20 |
62± 3 |
25± 5 |
19± 5 |
50± 5 |
Negative control |
149± 12 |
62± 3 |
33± 6 |
25± 4 |
56± 10 |
|
Test article 100% |
188± 4 |
67± 3 |
39± 6 |
19± 2 |
70± 12 |
|
Test article 50% |
177± 25 |
|
|
|
|
|
Test article 25% |
179± 12 |
|
|
|
|
|
Test article 10% |
158±7 |
|
|
|
|
|
Test article 1% |
113± 14 |
|
|
|
|
|
Positive control |
1093± 54 |
2260±172 |
576± 31 |
309± 38 |
466± 16 |
SR = Spontaneous Revertants
Table 3: Study 2 (0.9% NaCl extract, mean± standard deviation)
|
|
TA 100 |
TA 98 |
TA 1535 |
TA 1537 |
WP2 uvrA |
Without S9 mix |
SR |
183± 17 |
36± 5 |
17± 2 |
26± 4 |
40± 5 |
Negative control |
193± 5 |
46± 6 |
26± 10 |
26± 0 |
37±7 |
|
Test article 100% |
203± 20 |
53± 14 |
26± 3 |
30± 4 |
42± 5 |
|
Positive control |
560± 15 |
516± 29 |
631± 21 |
781± 52 |
389±19 |
|
With S9 mix |
SR |
155± 17 |
57± 2 |
15±4 |
31±0 |
54± 8 |
Negative control |
140±14 |
56± 2 |
18± 4 |
29± 5 |
62±8 |
|
Test article 100% |
139± 12 |
56± 2 |
23± 3 |
30± 3 |
59± 5 |
|
Positive control |
1010± 37 |
1780± 28 |
451± 26 |
142± 16 |
367±38 |
SR = Spontaneous Revertants
Table 4: Study 2 (96% ethanol extract, mean± standard deviation)
|
|
TA 100 |
TA 98 |
TA 1535 |
TA 1537 |
WP2 uvrA |
Without S9 mix |
SR |
183± 17 |
36± 5 |
17± 2 |
26± 4 |
40± 5 |
Negative control |
222± 11 |
54± 5 |
24± 4 |
25± 4 |
45± 10 |
|
Test article 100% |
212± 5 |
61± 9 |
23±3 |
30± 4 |
43± 3 |
|
Positive control |
560± 15 |
516± 29 |
631± 21 |
781± 52 |
389± 19 |
|
With S9 mix |
SR |
155± 17 |
57± 2 |
15± 4 |
31± 0 |
54± 8 |
Negative control |
259± 20 |
65± 7 |
33± 5 |
31± 7 |
55± 4 |
|
Test article 100% |
264± 9 |
77±13 |
26± 4 |
33± 7 |
63± 7 |
|
Positive control |
1010± 37 |
1780±28 |
451± 26 |
142± 16 |
367± 38 |
SR = Spontaneous Revertants
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, the test article extracted in 0.9% NaCl and 96% ethanol were not toxic and not mutagenic in the tested species. - Executive summary:
The Ames test was performed on the Sanyrene/Corpitol in order to evaluate the mutagenic potential of the test article. The study was conducted according to the requirements of the ISO 10993 standard: Biological evaluation of medical devices – Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity, and according to an adaptation of OECD Guideline n°471.
Extracts of the test article were prepared as follows:
- Extraction vehicles: 0.9% sodium chloride and 96% ethanol
- Duration: 72 +/- 2 hours with agitation
- Ratio test article/vehicle: 0.2 g/mL for the 0.9% NaCl extracts (study 1 & 2) and 96% ethanol extracts (study 1), 0.4 g/mL for the 96% ethanol extracts (study 2)
- Temperature: 37°C +/- 1°C
Suspensions of four strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and a strain of Escherichia coli WP2 uvrA were exposed to the test article extracted (up to 100%) in 0.9% NaCl and in 96% ethanol in the presence and in the absence of an exogenous metabolic activation system.
Under the conditions of this study, the test article extracted in 0.9% NaCl and 96% ethanol were not toxic and not mutagenic in the tested species. The extracts of the test article met the requirements of the test. The negative and positive controls performed as anticipated.
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