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EC number: 200-652-8 | CAS number: 67-43-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March-April 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD 471 protocol study under GLP; however 4 required strains were used, but no additional strain having AT base pairs at the primary reversion site (such as TA 102 or E. coli WP2 strains; as required in current OECD 471 (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Principles of method if other than guideline:
- 4 required strains were used, but no additional strain having AT base pairs at the primary reversion site (such as TA 102 or E. coli WP2 strains; as required in current OECD 471 (1997)).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Armogard S462
- Date of receipt: 21 March 1990
- Substance type: fine white powder
- Physical state: solid
- Analytical purity: 97.8%
- Lot/batch No.: AGH 01/96
- Stability under test conditions:stable
- Storage condition of test material: at ambient temperature, in a desiccator
Constituent 1
Method
- Target gene:
- reverse mutation to histidine independency
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat liver Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- 0, 5, 16, 50, 158 and 500 µg/plate
- Vehicle / solvent:
- Vehicle: distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 5 µg/plate (- and + S9 mix)
Migrated to IUCLID6: TA1537, TA98, TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 1 µg/plate (- S9 mix)
Migrated to IUCLID6: TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 80 µg/plate (- S9 mix)
Migrated to IUCLID6: TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene / TA1535
- Remarks:
- 2 µg/plate (- and + S9 mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 2 µg/plate (- S9 mix)
Migrated to IUCLID6: TA1535 and TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: overnight
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: all plates prepared in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: 2.5-5000 µg/plate using TA98. Toxicity was examined for the presence of a background lawn of non-revertant colonies;
toxicity is present by the absence ofr thinning of the background lawn. The lowest level causing visible thinning of the background
lawn of non-revertant cells was 500 µg/plate; this was therefore the top dose tested. - Evaluation criteria:
- Increases in revertant colony numbers over control counts.
- Statistics:
- Not used.
Results and discussion
Test results
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: none
- Water solubility: good
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: In the preliminary toxicity test, dose levels of 2.5 to 5000 µg/plate were tested. The lowest
level tested causing visible thinning of the background lawn was 500 µg/plate; this level was therefore selected as the top
exposure level. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Inhibition of growth and reduction in revertant colony numbers occurred in all strains at 500 µg/plate; reduction in revertant colony
numbers was also seen at the next lower level tested of 158 µg/plate in all strains on at least one occasion of testing in both the
absence and presence of S9 mix. It was concluded that the test material was non-mutagenic up to the maximum level tested of 500 µg/plate under the condition of this test. Although the tested strains (TA1537, TA1535, TA98 and TA100) may not detect certain
oxidising mutagens or cross-linikg agents, it is not expected that the test substance will do so. Therefore, it is concluded thatthere is no evidence of mutagenic potential of the test substance in this bacterial test system. - Executive summary:
Armogard S462 was examined for mutagenic activity in four histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98, TA 100, TA 1535 and TA 1537, using pour-plate assays. The procedures used complied with the OECD Guidelines for testing of chemicals (1983) and the EPA Toxic Substances Control Act Test Guidelines (1988). Each test, in each strain, was conducted on two separate occasions.
The studies, which were conducted in the absence and presence of an activating system derived from rat liver (S-9 mix), employed a range of levels of Armogard S462 from 5 to 500 µg per plate, selected following a preliminary toxicity test in strain TA 98. Al l tests included solvent (distilled water) controls with and without S-9 mix.
No increases in reversion to prototrophy were obtained with any of the four bacterial strains at the Armogard S462 levels tested, either in the presence or absence of S-9 mix. Inhibition of growth, observed as thinning of the background lawn of non-revertant cells and reduction in revertant colony numbers, occurred in all strains following exposure to Armogard S462 at 500 ug per plate. Reduction in revertant colony numbers was also seen with Armogard S462 at 158 µg per plate in all strains on at least one occasion of testing in both the absence and presence of S-9 mix.
Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2 -nitrofluorene, 2 -aminoanthracene,
9 -aminoacridine and sodium azide when examined under similar conditions.
It was concluded that Armogard S462 was devoid of mutagenic activity under the conditions of the 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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