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EC number: 614-455-3 | CAS number: 68411-07-4
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May 2010 to 20 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copper Lead Resorcylate Salicylate Complex
- EC Number:
- 614-455-3
- Cas Number:
- 68411-07-4
- Molecular formula:
- C7H5O4-, C7H5O3- Cu , Pb
- IUPAC Name:
- Copper Lead Resorcylate Salicylate Complex
- Details on test material:
- - Name of test material (as cited in study report): Lead-Cooper-Resorcylate-Salicylate (LC 12-15)
- Substance type: multicontituent
- Physical state: slightly pale green powder
- Composition of test material, percentage of components: copper: 11.9%, lead: 35.7%, resorcylate: 14.1%, salicylate: 35.7%
- Lot/batch No.: 09/201 (corresponding to lot N° PRESE123/
- Purity test date: 20 October 2009
- Expiration date of the lot/batch: 04 November 2011
- Storage conditions of test material: at room temperature.
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiments without S9 mix:
For the first experiment without S9 mix, the selected dose-levels were:
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains,
- 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain.
The selected dose-levels for the second experiment were:
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 100 and TA 102 strains,
- 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 1535 and TA 1537 strains,
- 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain.
For the third experiment performed only with TA 102 strain, the selected dose-levels were 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate.
Experiments with S9 mix:
The selected dose-levels for both mutagenicity experiments were:
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains,
- 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain. - Vehicle / solvent:
- Vehicle used: water for injections.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The preliminary test, all experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate incorporation method. The second experiment with S9 mix was performed according to the preincubation method.
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: 48 to 72 hours.
DETERMINATION OF CYTOTOXICITY
- Method: thinning of the bacterial lawn, decrease in the number of revertants - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a
positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the
data obtained.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate in the TA 1537 and TA 100 strains and at dose-levels >= 1000 µg/plate in the TA 98 strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose-levels >= 500 µg/plate in the TA 1535, TA 100 and TA 98 strains and at 1000 µg/plate in the TA 1537 strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose-levels >= 250 µg/plate (second experiment) and at 500 µg/plate (third experiment)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose-levels >= 125 µg/plate in the TA 1537 strain, at 500 µg/plate in the TA 1535 and TA 100 strains, and at 2000 µg/plate in the TA 98 strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose-levels >= 250 µg/plate in the TA 1537 and TA 100 strains, at 500 µg/plate in the TA 1535 strain, and at 2000 µg/plate in the TA 98 strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose-levels >= 250 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
During the solubility assay, the test item was found not soluble in the vehicles usually used for this type of assay. Consequently, a suspension was
selected for the treatment. An homogenous suspension (to the naked eye) was obtained in water for injections at the concentration of 50 mg/mL.
Using a treatment volume of 100 µL/plate, the highest dose-level tested in the preliminary test was 5000 µg/plate, which is the highest dose-level
recommended in the international guidelines. Successive dilutions of the stock preparation were also performed in water for injections and used with a treatment volume of 100 µL/plate. Therefore the dose-levels tested in the preliminary test were 10, 100, 500, 1000, 2500 and 5000 µg/plate.
For the preliminary test, the test item was first suspended in water for injections at 50 mg/mL, and then successive dilutions of this stock preparation were performed. Using a treatment volume of 100 µL/plate, the dose-levels tested in the preliminary test were 10, 100, 500, 1000, 2500 and 5000 µg/plate; the latter being the highest dose-level recommended in the international guidelines.
A moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 100 µg/plate.
Regarding the toxicity of the test item towards the bacteria strain, a moderate thinning of the bacterial lawn was noted at dose-levels >= 500 µg/plate and a strong decrease in the number of revertants at dose-levels >= 2500 µg/plate in the TA 98 strain either with or without S9 mix.
In the TA 100 and TA 102 strains, a strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn was observed at
dose-levels >= 500 µg/plate either with or without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- the number of revertants in the vehicle controls was consistent with the historical data of the testing facility;
- the number of revertants in the positive controls was consistent with the historical data of the testing facility. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: incorporation plate method
Any other information on results incl. tables
The sterility of the test item (stock preparation) was checked and found satisfactory.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item Lead-Copper-Resorcylate-Salicylate (LC12-15) did not show any mutagenic activity in the bacterial reverse mutation test with
Salmonella typhimurium, either in the presence or in the absence of metabolic activation. - Executive summary:
The objective of this study was to evaluate the potential of the test item Lead‑Copper‑Resorcylate-Salicylate (LC12-15) to induce reverse mutation in Salmonella typhimurium.
The study was performed according to the international guidelines (OECD guideline No. 471 and Commission Directive No. 200/32/EC, B13/14) and in compliance with the principles of Good Laboratory Practice.
Methods
A preliminary toxicity test was performed to define the dose-levels of Lead-Copper-Resorcylate-Salicylate (LC12-15) to be used for the mutagenicity study. The test item was then tested in three independent experiments, with and/or without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
All experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes,).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The dose-levels of the positive controls were as follows:
without S9 mix
. 1 µg/plate of sodium azide (NaN3): TA 1535 and TA 100 strains,
. 50 µg/plate of 9-Aminoacridine (9AA): TA 1537 strain,
. 0.5 µg/plate of 2-Nitrofluorene (2NF): TA 98 strain,
. 0.5 µg/plate of Mitomycin C (MMC): TA 102 strain.
with S9 mix
. 2 µg/plate of 2-Anthramine (2AM): TA 1535, TA 1537 and TA 98 strains,
. 5 µg/plate of Benzo(a)pyrene (BAP): TA 100 strain,
. 10 µg/plate of 2-Anthramine (2AM): TA 102 strain.
Results
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
The test item Lead-Copper-Resorcylate-Salicylate (LC12-15) was suspended in water for injection.
Since the test item was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Experiments without S9 mix
For the first experiment without S9 mix, the selected dose-levels were:
. 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains,
. 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain.
A moderate precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 125 µg/plate.
A moderate to strong toxicity was noted at dose-levels >= 500 µg/plate in the TA 1537, TA 100 and TA 102 strains and at dose-levels >= 1000 µg/plate in the TA 98 strain.
The selected dose-levels for the second experiment were:
. 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 100 and TA 102 strains,
. 31.3, 62.5, 125, 250, 500 and 1000 µg/plate for the TA 1535 and TA 1537 strains,
. 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain.
A moderate precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 62.5 µg/plate in the TA 100 strain, at dose-levels >= 125 µg/plate in the TA 1535, TA 1537 and TA 102 strains and at dose-levels >= 250 µg/plate in the TA 98 strain.
For the third experiment performed only with TA 102 strain, the selected dose-levels were 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate. A moderate precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 125 µg/plate. A moderate to strong toxicity was noted at dose-levels >= 500 µg/plate.
Slight increases in the number of revertants (up to 2.2-fold the vehicle control value) were noted in the TA 102 strain in the first experiment. These increases exceeded the threshold of 2-fold the vehicle control value at the dose-level of 62.5 µg/plate. But, since these increases were not observed in the second and third experiments performed under the same experimental conditions, they were considered to not be biologically significant.
The test item did not induce any other noteworthy increase in the number of revertants in the other strains tested in the absence of metabolic activation.
Experiments with S9 mix
The selected dose-levels for both mutagenicity experiments were:
. 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains,
. 62.5, 125, 250, 500, 1000 and 2000 µg/plate for the TA 98 strain.
In the first experiment performed using the direct plate incorporation method, a moderate precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 125 µg/plate. Moreover, a moderate to strong toxicity was noted at dose-levels >= 125 µg/plate in the TA 1537 strain, at dose-levels >= 500 µg/plate in the TA 1535, TA 100 and TA 102 strains, and at 2000 µg/plate in the TA 98 strain.
In the second experiment performed using the preincubation method, a moderate precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 62.5 µg/plate in the TA 98 and TA 100 strains and at dose-levels >= 125 µg/plate in the TA 1535, TA 1537 and
TA 102 strains. Moreover, a moderate to strong toxicity was noted at dose-levels >= 250 µg/plate in the TA 1537, TA 100 and TA 102 strains, at dose-levels >= 500 µg/plate in the TA 1535 strain, and at 2000 µg/plate in the TA 98 strain.
In the presence of metabolic activation, the test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.
Conclusion
Under the experimental conditions of the study, the test item Lead-Copper-Resorcylate-Salicylate (LC12-15) did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium,either in the presence or in the absence of metabolic activation.
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