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EC number: 807-655-9 | CAS number: 1629160-48-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance is not mutagenic in Ames assay.
Link to relevant study records
- 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:
- 25 June 1993 to 29 September 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Use of Sodium Azide (NaA) instead of Methyl Methane Sulfonate (MMS) as positive control on TA100 without metabolc activation. The test article appearance was not lquid to viscous as mentioned in the signed protocol.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3.86
- Expiration date of the lot/batch:
August 1994
- Identification: Steaiyl-Diphenoxyethyl-Dimethylentriamin (FAT 92267/A)
- Dispensary code no: 515-93
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature - Target gene:
- Salmonella typhimurium histidine (his) reversion system.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from liver of rats treated with AROCLOR 1254.
- Test concentrations with justification for top dose:
- - Preliminary study only on strain TA 100: 6173/1235/247/49/10 µg/plate corresponding to active ingredient concentrations of 5000/1000/200/40 and 8 µg/plate.
- Main study number 1 (in all strain): 6173/1235/247/49/10 µg/plate corresponding to active ingredient concentrations of 5000/1000/200/40 and 8 µg/plate.
- Main study number 2 (in all strain): 6173/3087/1543/772/386 µg/plate corresponding to a active ingredient concentrations of 5000/2500/1250/625/313 µg/plate. - Vehicle / solvent:
- - Identification: Absolute ethanol
- Supplier: Prolabo
- Batch number: 92113 and 92350. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Absolute ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation: TA98, TA1538, TA1537, TA1535, TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA98 TA1538
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation: TA1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation: TA 100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
NUMBER OF REPLICATIONS: Triplicate
All the preparations were used on the day of formulation.
Treatment design:
After treatment each tube of molten agar contains:
- 2 ml of molten agar
- 100 µl of bacterial culture
- 50 or 100 µl of the test article formulated depending on the vehicle used
- 500 µl of S9 Mix (if appropriate)
The mixture will be poured onto VB medium constituting an agar upper layer. The petri dishes will be incubated at 37 °C ± 1 °C for 48 hours minimum. - Evaluation criteria:
- The assay will usually be considered valid if the following criteria are met:
- The mean negative control counts fall within the normal range.
- The positive control chemicals induce clear increases in revertant numbers.
confirming discrimination between different strains, and an active Sc Mix preparation
- No more than 5 % of the plates in the assay are lost through contamination or some other unforeseen event.
The test article will be considered to be clearly mutagenic if:
- The number of revertants in presence of the test article is greater than or equal to twice the number of revertants in the negative control at one dose level (the upper dose before toxicity) or more with a dose correlation
- The positive trends/effects are reproducible. - Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was observed at 1235 and 6173 microgr./plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- Remarks:
- Toxicity was observed at 1235 and 6173 microgr./plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- FAT 92267/A is not mutagenic in Ames assay.
- Executive summary:
The bacterial reverse mutation assay was performed following OECD Guideline 474. The test was performed under GLP. The mutagenic potential of FAT 92267/A was evaluated using Salmonella typhimurium in the absence and presence of a liver microsomal system. The test article (FAT 92267/A) was tested on 5 strains of Salmonella typhimurium (TA98, TA 100, TA 1535, TA 1537, TA 1538), with and without metabolic activation. A range of sub-toxic concentrations was determined in a preliminary study on the strain TA 100 without metabolic activation. The 5 concentrations (6173, 1235, 247, 49 and 10 µg/plate corresponding to active ingredient concentrations of 5000, 1000, 200, 40 and 8 µg/plate, respectively) were tested in triplicate on the strains mentioned above with and without metabolic activation. The results were confirmed in a second independent study, using a closer range near to the top limit dose (6173, 3087, 1543, 772 and 386 µg/plate corresponding to active ingredient concentrations of 5000, 2500, 1250, 625 and 313 µg/plate respectively). A negative control (vehicle) and a positive control (specific standard mutagen) were included in each study. Under the experimental conditions employed, it can be concluded that FAT 92267/A, did not cause an increase in the number of revertants per plate of any tester strains used TA 98, TA 100, TA 1535, TA 1537 and TA 1538 either in presence or absence of a metabolic activation system in both the two independent studies performed.
Reference
- PRELIMINARY STUDY:
A precipitate appeared during incorporation of the test article solutions at concentrations of 6173 and 1235 µg/plate.
- MAIN STUDY No1:
A precipitate was noted during incorporation at 1235 and 6173 µg/plate. On a few occasion the colonies were counted manually instead of automatically.
*Without metabolic activation:
Signs of toxicity were observed at 6173 microgr./plate in all the tester strains and at 1235 µg/plate in TA1535, TA 1537 and TA 1538 only. For all tested concentrations, the mean number of colonies was less than twice the mean number of colonies in the negative control except with TA1537 at 6173 µg/plate where severe toxicity was noted. In this case, the increase of the mean number of colonies cannot be interpreted as the result of a mutagenic activity. All data were acceptable and no positive increase in the number of revertants per plate containing the test article was observed with any of the tester strains. All criteria for a valid study were met.
*With metabolic activation:
Signs of toxicity were noted in all the tester strains at 6173 µg/plate. For all tested concentrations, the mean number of colonies was less than twice the mean number of colonies in the negative control with each of the tester strains. All data were acceptable and no positive increase in the number of revertants per plate containing the test article was observed with any of the tester strains. All criteria for a valid study were met.
- MAIN STUDY N°2:
From the results obtained in the first study, a closer range of doses near to the top limit dose were used in this study: 386 / 772 / 1543 / 3087 and 6173 microgr./plate in both the presence and absence of metabolic activation system (corresponding to active ingredient concentrations of 313, 625, 1250, 2500 and 5000 µg/plate, respectively). The highest dose-level corresponded approximately to an active ingredient concentration of 5000 µg/plate which is the required maximum dose-level. A precipitate was constantly noted after the incorporation at 1543 / 3087 and 6173 µg/plate. Precipitation was also occasionally seen at lower dose levels. As a result of this precipitate, colonies were systematically counted manually at 6173 µg/plate and on a few occasions only at 3087 and 1543 µg/plate.
*Without metabolic activation:
Toxicity was observed in all the tester strains at the two highest dose-levels except with TA98 at 3087 µg/plate. For all concentrations, the mean number of colonies was less than twice the mean number of colonies in the negative control with each of the tester strains. All data were acceptable and no positive increase in the number of revendants per plate containing the test article was observed with any of the tester strains. All criteria for a valid study were met.
*With metabolic activation:
Toxicity was observed in all the tester strains at the highest dose-level of 6173 µg/plate. For all concentrations, the mean number of colonies was less than twice the mean number of colonies in the negative control with each of the tester strains. All data were acceptable and no positive increase in the number of revertants per plate containing the test article was observed with any of the tester strains. All criteria for a valid study were met.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The bacterial reverse mutation assay was performed following OECD Guideline 471. The test was conducted under GLP conditions.The mutagenic potential of FAT 92267/A was evaluated using Salmonella typhimurium in the absence and presence of a liver microsomal system. The test article (FAT 92267/A) was tested on 5 strains of Salmonella typhimurium (TA98, TA 100, TA 1535, TA 1537, TA 1538), with and without metabolic activation. A range of sub-toxic concentrations was determined in a preliminary study on the strain TA 100 without metabolic activation. The 5 concentrations (6173, 1235, 247, 49 and 10µg/plate corresponding to active ingredient concentrations of 5000, 1000, 200, 40 and 8 µg/plate, respectively) were tested in triplicate on the strains mentioned above with and without metabolic activation. The results were confirmed in a second independent study, using a closer range near to the top limit dose (6173, 3087, 1543, 772 and 386µg/plate corresponding to active ingredient concentrations of 5000, 2500, 1250, 625 and 313µg/plate respectively). A negative control (vehicle) and a positive control (specific standard mutagen) were included in each study. Under the experimental conditions employed, it can be concluded that FAT 92267/A, did not cause an increase in the number of revertants per plate of any tester strains used TA 98, TA 100, TA 1535, TA 1537 and TA 1538 either in presence or absence of a metabolic activation system in both the two independent studies performed.
Justification for classification or non-classification
Based on the findings of the genetic toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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