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Diss Factsheets
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EC number: 911-418-6 | CAS number: 55965-84-9
- 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
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- histidine-gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- -bacterial suspension and test substance mixed withg molten agar
-checked for strain characteristis within last 2 hours of treatment (Maron et al., DeSerres et al.) - Additional strain / cell type characteristics:
- other: histidine-requiring
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- -bacterial suspension and test substance mixed withg molten agar
-checked for strain characteristis within last 2 hours of treatment (Maron et al., DeSerres et al.) - Additional strain / cell type characteristics:
- other: histidine-requiring
- Metabolic activation:
- with and without
- Metabolic activation system:
- Acrolor 1254 induced rat liver post-mitochondrial fraction (S-9) of the male Sprague Dawley strain.
- Test concentrations with justification for top dose:
- Mutation experiment 1:
Without S9: 1.25, 2.5, 5, 10, 15 µg/plate
With S9 (10%): 6.25, 12.5, 25, 50, 100 µg/plate
Mutation experiment 2:
Without S9: 1.25, 2.5, 5, 10, 15µg/plate
With S9 (10%): 10, 20, 40, 60, 80 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: purified water
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: nitrofluoroene, aminoacridine, gluataldehyde, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure /selection duration: 3 days
NUMBER OF REPLICATIONS: 3/concentration, two experiments
CELL COUNTING
-electronically: SeeScanplc
DETERMINATION OF CYTOTOXICITY
- examination of the background lawn
VERIFICATION OF RESULTS
-revertant colonies transferred to fresh plates; all colonies grew - Evaluation criteria:
- valid if
-mean of negative control within historical control data
-positive controls clearly increase number of revertants, starin dependent
-no more than 5% of the pülates lost due to contamination/unforseen events
positive, if:
-statistically significant (Dunnett`s, p < 0.01) increase in no. of revertants
-positive effects reproducible - Statistics:
- Dunnett`s test
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: Toxicity range-finder experiment with TA100: |3.55 - 7.10 µg a.i./plate without S-9 mix|>= 17.75 µg a.i./plate with S-9 mix
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
in TA100:
toxic at >25 Acticide14/plate without S-9, toxic at >125 µg Acticide14/plate with S-9
COMPARISON WITH HISTORICAL CONTROL DATA:
controls: within historical controls
- Remarks on result:
- other: other: Salmonella typhimurium (strains TA98, TA100, TA1535, TA1537 and TA102)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
table 1: Strain Mean Revertants (Experiment 2)
with S-9 | without S-9 | ||||||||||
Treatement [µg/plate] Treatment [µg/plate] |
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 102 | Treatment [µg/plate] | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 102 |
0 | 37.4 | 105.8 | 6.6 | 9.8 | 380.6 | 0 | 28.6 | 85.6 | 5.8 | 7.6 | 322.0 |
10 | 38.0 | 193.3 *** | 8.0 | 12.3 | 503.0 | 1.25 | 35.3 | 183.3 *** | 3.0 | 11.7 | 435.3 *** |
20 | 40.7 | 258.3 *** | 5.3 | 13.3 | 500.7 | 2.5 | 34.3 | 277.7 *** | 5.7 | 14.0 * | 527.7 *** |
40 | 46.0 | 301.7 *** | 5.7 | 12.3 | 497.0 | 5 | 37.7 * | 495.3 *** | 4.7 | 19.7 *** | 693.3 *** |
60 | 43.3 | 323.3 *** | 8.0 | 13.7 | 598.0 | 10 | 46.3 *** | 1016 *** | 8.0 | 22.3 *** | 890.0 *** |
80 | 41.3 | 460.7 *** | 6.3 | 13.7 | 673.7 | 15 | 69.3 *** | 1411 *** | 13.3 *** | 32.0 *** | 1016.0 *** |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
ACTICIDE 14 was mutagenic in the Ames-test. Presence of metablic activation system reduced mutagenicity. - Executive summary:
The mutagenic potential of a 14% aqueous solution of 3 parts 5 -chloro-2 -methyl-2H-isothiazol-3 -one and 1 part 2 -methyl-2H-isothiazol-3 -one (cited as ACTICIDE 14 in the report) was evaluated in a bacterial mutation assay according to guideline EPA OPP 84 -2. Five histidine-requiring test strains of Salmonella typhimurium were treated with the test substance for 3 days in the presence or absence of a metabolical activation system under histidine-exclusion. The number of colonies observed represented the number of suviving bacteria and thus the number of back-mutations to the histidine-gene.
Acticide 14 clearly demonstrated an ability to induce mutation in 5 strains aof Salmonella typhimurium, when tested up to concentrations close to, or within, the toxic range. The mutagenic activity observed was greatly reduced (but nevertheless still detectable) when testing was carried out in the presence of a rat liver metabolic activation system.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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