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EC number: 221-346-0 | CAS number: 3072-84-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10/10/2012-26/03/2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- other: the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF
- Qualifier:
- according to guideline
- Guideline:
- other: the USA, EPA (TSCA) OPPTS harmonised guidelines.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):F-2200HM
- Physical state:Off-white powder
- Analytical purity: >99%
- Lot/batch No.:290110772
- Expiration date of the lot/batch: 12/2014
- Storage condition of test material:
- Other: ambient storage conditions in darkness
Constituent 1
Method
- Target gene:
- hisD, hisG, hisC, trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 μg/plate
Experiment 1: 50, 150, 500, 1500, 5000μg/plate
Experiment 2: 15, 50, 150, 500, 1500, 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: fully soluble in DMSO, 100mg/ml in aceton
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation. Strains: WP2uvrA, TA100, TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation. Strain TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation. Strain TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene for strain TA100, TA1535, Ta1537, WP2uvrA
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation. Strain TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Positive control substance:
- other: DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:/
- Exposure duration:48h
- Expression time (cells in growth medium):48h
NUMBER OF REPLICATIONS:3 - Rationale for test conditions:
- According to test guidelines
- Evaluation criteria:
- 1. A dose related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations
3. Biological relevance against in-house historical control ranges
4. Statistical analysis of data as determined by UKEMS
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accomponied by an out-of-historical range response).
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- RANGE-FINDING/SCREENING STUDIES: The test item was non-toxic to the strains of bacteria used (TA100 and WP2uvrA).
The test item formulation and S9-mix used in this experiment were both shown to be sterile
COMPARISON WITH HISTORICAL CONTROL DATA: yes - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test item, the substance was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Introduction:The test method was designed to be compatible with the guidelines for
bacterial mutagenicity testing published by the major Japanese Regulatory Authorities
including METI, MHLW and MAFF, the OECD Guidelines for Testing of Chemicals No.
471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC)
number 440/2008 of 30 May 2008 and the USA, EPA (TSCA) OPPTS harmonised
guidelines.
Methods. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and
Escherichia coli strain WP2uvrA were treated with the test item, F-2200HM, using both
the Ames plate incorporation and pre-incubation methods at up to six dose levels, in
triplicate, both with and without the addition of a rat liver homogenate metabolising
system (10% liver S9 in standard co-factors). The dose range for the range-finding test
was determined in a preliminary toxicity assay and was 15 to 5000 ~g/plate. The
experiment was repeated on a separate day (pre-incubation method) using an amended
dose range (50 to 5000 ~g/plate), fresh cultures of the bacterial strains and fresh test
item formulations. An additional dose level was included in the range-finding test to
allow for potential test item toxicity following reductions in revertant colony frequency in
the preliminary toxicity test.
Results. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant
colonies within the normal range. All of the positive control chemicals used in the test
induced marked increases in the frequency of revertant colonies, both with or without
metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix
were validated.
The test item caused no visible reduction in the growth of the bacterial background lawn
at any dose level and was, therefore, tested up to the maximum recommended dose
level of 5000 ~g/plate. A test item film (creamy in appearance) was noted from
1500 ~g/plate with an associated precipitate observed at 5000 ~g/plate. For the plates
dosed with S9-mix the film was noted to have spread and separated to a greater degree
than on plates dosed in the absence of S9-mix. Neither of these observations prevented
the scoring of revertant colonies.
PROJECT NUMBER: 41205168 PAGE 6
No toxicologically significant increases in the frequency of revertant colonies were
recorded for any of the bacterial strains, with any dose of the test item, either with or
without metabolic activation or exposure method. A small, statistically significant
increase in T A 1535 revertant colony frequency was observed in the presence of S9-mix
at 50 IJg/plate in the range-finding test. This increase was considered to be of no
biological relevance because there was no evidence of a dose-response relationship or
reproducibility. Furthermore, the individual revertant colony counts at 50 IJg/plate were
within the in-house historical untreated/vehicle control range for the tester strain and the
fold increase was only 1.26 times the concurrent vehicle control.
Conclusion. The test item, F-2200HM was considered to be non-mutagenic under the
conditions of this test.
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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