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EC number: 700-371-5 | CAS number: 178535-25-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 July 2002 to 24 July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to OECD guideline 471 and Eu Method B13/14 nad it is GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- .
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ethylbenzene
- EC Number:
- 700-371-5
- Cas Number:
- 178535-25-6
- IUPAC Name:
- ethylbenzene
- Details on test material:
- - Name of test material (as cited in study report): Ethylbenzene, manuf. of, distn. residues, distn. lights.
- Physical state: Clear, liquid yellow liquid
- Purity test date: 100%
- Lot/batch No.: P0204-1936
- Stability under test conditions: Stable for the duration of the test
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- Reversion to histidine independence in Salmonella typhimurium and reversion to tryptophan independence in Escherichia coli.
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):
- - Type and identity of media: The batches are aliquots of nutrient broth cultures stored at -80C.
- Properly maintained: yes
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The batches were aliquots of nutrient broth cultures and were stored at -80C.
- Properly maintained: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Dose range-finding: 5, 15, 50, 150, 500, 1500 and 5000 ug/plate
Definitive test: 50, 150, 500, 1500 and 5000 ug/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Test media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix for strains TA1537, TA98 and TA100
Migrated to IUCLID6: 5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Test media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 1 µg/plate
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9 mix for strain TA98
Migrated to IUCLID6: 1 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Test media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 0.5 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- Without S9 mix for strainsTA 1535 and TA100
Migrated to IUCLID6: 0.5 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9 mix for strain WP2uvrA/pKM101
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 50 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9 mix for strain TA1537
Migrated to IUCLID6: 50 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9 mix for strain WP2 uvrA/pKM101
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate (pre-incubation method)
DURATION
- Preincubation period: 1st test 10 hours, 2nd test: 30 minutse
- Exposure duration: 72 hours
NUMBER OF CELLS EVALUATED: 1000000000 cells/mL
Three replicates were used at each concentration. - Evaluation criteria:
- If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice the concurrent solvent/vehicle controls, with some evidence of a positive dose-relationship (increased revertant colony counts at concentrations below that at which the maximal increase is obtained., it will be considered to show evidence of mutagenic activity in this system.
If exposure to a test substance does not produce an increase in revertant colony numbers in two separate experiments, with any bacterial strain either in the presence or absence of S9 mix, it will be considered to show no evidence of mutagenic activity in this test system.
If the results obtained fail to satisfy the criteria for a clear "positive" or "negative" response, even after the additional testing outlined in the mutation test procedure, the test data may be subjected to analysis to determine the statistical significance of any increase in revertant colony numbers. The statistical procedures used will be those described by Mahon et al (1989) and will usually be analysis of variance followed by Dunnett`s test. Biological significance should always be considered along with statistical significance. - Statistics:
- Statistical analysis is not performed unless the results faild to identify a clear positive or negative response, the test data may be subjected to analysis to determine the statistical significance of any increase in revertant colony numbers. The statistical procedures used will be those described by Mahon et al (1989) and will usually be analysis of variance followed by Dunnett`s test.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The range-finding test was carried out in the presence and absence of S9 mix up to 5000 µg/plate. No substantial increases in revertant colony numbers were reported at any concentration tested.
COMPARISON WITH HISTORICAL CONTROL DATA: The mean revertant colony counts for the solvent controls were within the 99% confidence limits of the current historical control range of the laboratory - 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
Under the conditions of this study, Ethylbenzene, manuf. of, distn. residues, distn. lights. is not considered to be mutagenic. - Executive summary:
An in vitro gene mutation assay was carried out on Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and a tryptophan dependent mutant of Escherichia coli, strain WP2uvrA/pKM101. The strains were exposed to Ethylbenzene, manuf. of, distn. residues, distn. lights. at concentration up to 5000 µg/plate. The test 1 was tested at 5, 15, 50, 150, 500, 1500 and 5000 ug/plate and the test 2 was performed at
50, 150, 500, 1500 and 5000 ug/plate. L
Ethylbenzene, manuf. of, distn. residues, distn. lights. was diluted in DMSO which was used as negative control. No signs of toxicity were observed towards the tester strains in test 1. Toxicity (thinning of the background lawn of non-revertant cells, together with a reduction in revertant colony numbers) was seen in all strains except CM891 following to Ethylbenzene, manuf. of, distn. residues, distn. lights. at 5000 µg/plate. No evidence of mutagenic activity was seen at any concentration of Ethylbenzene, manuf. of, distn. residues, distn. lights. in either mutation test. The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. It can be concluded that, under the test conditions employed, Ethylbenzene, manuf. of, distn. residues, distn. lights. is not considered to be mutagenic.
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