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EC number: 605-200-7 | CAS number: 160194-28-5
- 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
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:
- 2014-06-16 to 2014-07-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD method and in accordance with GLP.
- 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)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Four histidine-requiring strains (Salmonella typhimurium (TA1535, TA1537, TA98 and TA100)) and one tryptophan-requiring strain (Escherichia coli (WP2uvrA).
- Species / strain / cell type:
- other: Salmonella typhimurium: TA1535, TA1537, TA98, TA100. Escherchia coli WP2uvrA.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix (rat liver S9-mix induced by Aroclor 1254)
- Test concentrations with justification for top dose:
- For genotoxicity experiment concentrations (with & without metabolic activation) used: 5000 ug/plate for plate incorporation method.
- Vehicle / solvent:
- Solvent- ethanol
- Untreated negative controls:
- yes
- Remarks:
- Ethanol
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 2.5 ug/plate (TA98) without s-9 - Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation
- Details on test system and experimental conditions:
- Precipitation of Bis-Tes (dried) on the plates was observed at the start and at the end of the incubation
period at concentrations of 1600 and 5000 µg/plate. Except in the tester strains TA1535, TA1537 and
TA100 in the absence of S9-mix, in which no precipitation of the test substance was observed at
1600 µg/plate.
There was no reduction of the bacterial background lawn and no
biologically relevant decrease in the number of revertants at any of the concentrations tested in all
tester strains in the absence and presence of S9-mix.
In strain TA1537 (presence of S9-mix), a fluctuation in the number of revertant colonies below the
laboratory historical control data range was observed at the mid dose of 164 µg/plate. However, since
no dose-relationship was observed, the reduction is not considered to be caused by toxicity of the test
substance - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the
concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or
WP2uvrA is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent
control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is
greater than three (3) times the concurrent vehicle control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester
strains, the positive response should be reproducible in at least one independently repeated
experiment. - Statistics:
- Mean and standard deviation of the plate counts for each treatment were determined.
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: yes. Negative control values were within the laboratory historical control data ranges, except for TA1535 in the presence of S9-mix (1st experiment). Since this value was just outside the limit of the range, the validity of the test was not affected.
- Positive controls validity:
- valid
- Additional information on results:
- There were no deviations from standard operating procedures that affected the integrity of the study.
Bis-Tes (dried) did not induce a significant dose-related increase in the number of revertant (His+
)
colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of
revertant (Trp+
) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic
activation. These results were confirmed in an independently repeated experiment. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that Bis-Tes (dried) is not mutagenic in the
Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
No increase in the number of revertants was observed upon treatment with Bis-Tes (dried) under all
conditions tested. Bis-Tes (dried) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the results of this study it is concluded that Bis-Tes (dried) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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