Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-874-9 | CAS number: 25340-17-4
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted similar to OECD TG-471 and in accordance to GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- Not specified in report.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethylbenzene
- EC Number:
- 246-874-9
- EC Name:
- Diethylbenzene
- Cas Number:
- 25340-17-4
- Molecular formula:
- C10H14
- IUPAC Name:
- diethylbenzene
- Reference substance name:
- o-diethylbenzene
- EC Number:
- 205-170-1
- EC Name:
- o-diethylbenzene
- Cas Number:
- 135-01-3
- Molecular formula:
- C10H14
- IUPAC Name:
- 1.2-diethylbenzene
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
DEB (m,p,o isomers)
Purity 98%
Compound name: Dowtherm*J
Lot# MM871021
Appearance: Clear liquid
Constituent 1
Constituent 2
Method
- Target gene:
- TA98- hisD3052, TA100-hisG46, TA1535- hisG46, and TA1537-hisC3076
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- The tester strains were originally obtained from Dr. Bruce N. Ames, University of California, Berkeley, CA,
and are currently maintained in our laboratory as frozen permanents at -100°C or below. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Exogenous metabolic activation was provided by male Sprague-Dawley rat liver S-9 preparations from Aroclor 1254.
- Test concentrations with justification for top dose:
- 0 (DMSO), 5.0, 15.8, 50.0, 158.0, 500.0 1580.0 and 5000.0 µg/plate.
- Vehicle / solvent:
- DEB was dissolved in DMSO and incubated with the tester strains in suspension culture for 30 min prior to the addition of soft agar and plating-out.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA100 & TA1535 (non-activated)- sodium azide, TA98 (non-activated)- 2-nitrofluorene, TA1537 (non-activated)-ICR-191 and TA98, 100, 1535 and 1537 (activated)- 2-anthramine
- Details on test system and experimental conditions:
- IUCLID4 Type: Ames test
All dose levels along with the positive and negative controls were assayed in triplicate.
Mutagenicity Assay
The pre-incubation modification of the standard Ames plate incorporation assay (Yahagi et al., 1975) was employed to optimize the contact between the bacteria and test chemical. Pre-incubation of the bacteria and the metabolic activation system is required for chemicals such as dimethylnitrosamine to elicit a positive response in the Ames test (Bartsch et al . , 1976). The bacteria, test chemical, and, if necessary, an activation mixture were incubated in sterile 12 x 75 mm tightly capped culture tubes in a gyratory incubator (300 RPM) at 30C for 30 minutes. After the 30 minute incubation, 2 ml of supplemented top agar were added, the overlay poured onto plates, and the plates were placed in a 37°C incubator for approximately 2 days. All negative and positive controls were also pre-incubated. The total volume of incubation mixture was 0.7 ml and included:
(a) 0.5 ml of S-9 activation mixture or 0.5 m l of 0.2 M sodium phosphate buffer, pH 7.4,
(b). 0.1 ml of an overnight bacterial culture, and
(c) 0.1 m l of test chemical solution or solvent.
Test Concentrations
The test material was dissolved in dimethyl sulfoxide (DMSO). The test material was shown to be stable in DMSO for at least 4 h (Campbell, 1988).
The negative control (solvent) plates consisted only of bacterial culture, 0.5 m l of 0.2 M sodium phosphate buffer or 0.5 ml S-9 activation mixture,
and 0.1 ml of solvent. All positive controls were prepared in DMSO except , for sodium azide, which was prepared in distilled water. All dose levels
along with ,the positive and negative controls were assayed in triplicate. The test agent was initially assayed in TA100 at various dose levels. The
concentrations tested in the other three strains were based upon the toxicity observed in TA100.
Colony Counting
The revertant colonies were counted either manually or using an Artek automatic colony counter, Model 880. The counter is calibrated periodically by using computer-generated " artificial plates" consisting of a specified number of randomly placed dots within a circle the size of a petri dish.
Transparencies of the "artificial plates" are counted in the same manner as a routine bacterial plate. A correction factor was determined to compensate for the area not scanned by the counter (i.e., dish edge) and overlapping colonies. This correction factor was used to automatically adjust
the observed number of colonies on each plate to more accurately reflect the actual number of colonies present. - Evaluation criteria:
- Overtly toxic concentrations of the test chemical are easily visualized as showing no-bacterial growth on the plate (i.e ., absence of background
lawn). Lower levels of toxicity may be seen as a thin or sparse bacterial lawn, a reduction in the number of revertants, or the appearance of microcolonies (overgrown background lawn). Positive and negative controls are run concurrently with the test chemical , and appropri ate responses for
these controls are prerequisites for evaluating the response o f the bacteria to the test chemical.
A test chemical is considered a bacterial mutagen if both the mean number of revertant colonies observed is at least three times higher than the mean of the negative (solvent) control and it produces a dose response in relation to concentrations tested. If a chemical produces reproducible revertant rates in excess of 3X over background, but no definitive dose response relationship, it is considered to be a presumptive bacterial mutagen. Increased revertant rates at a single dose near the highest toxic concentration will be examined critically for biological significance. If a
chemical produces reproducible revertant rates greater than 2X but less than 3X over the negative controls at several concentrations, the results
are considered to be equivocal or inconclusive. Test substances failing to meet the above criteria are considered non-mutagenic in this system. - Statistics:
- None
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- =/>50ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- =/>50ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- =/>50ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- =/>50ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Initially, DEB was assayed in TA100 at dose levels of 5.0, 15.8, 50 158.0, 500.0, 1580.0, and 5000.0 µg/plate. In the absence of S-9, excessive bacterial toxicity was observed at concentrations of 50 µg/plate and above. Hence, the highest concentration tested in all subsequent assays was limited to 15.8 µg/plate.
There was no evidence of mutagenic activity for the test chemical in TA98, TA1000, and TA1537. In TA1535, the mutation frequency in the absence of S-9 at some test chemical concentrations were found to be doubled. However, such an effect was non-reproducible in a repeat assay. Hence, the increases seen in the initial assay were interpreted to be unrelated to treatment.
The responsiveness of the tester strains to mutagens is clearly demonstrated by the marked increases in revertant frequency in positive control treatments,
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material did not induce a mutagenic response in any of the tester strains as judged by the frequency of histidine-dependent (his+) revertants. Hence, the test material was classified as negative in the AMES test under the experimental conditions used. - Executive summary:
Dowtherm*J heat transfer fluid (diethyl benzene) was evaluated in the Salmonel1a/mammalian-microsome bacterial mutagenicity assay (Ames test ) using the preincubation modification of the standard assay. The test material was assayed in the presence and absence of an externally supplied metabolic activation system
(S-9) using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535, and TA1537. The test material did not induce a mutagenic response in any of the tester
strains as judged by the frequency of histidine-independent (hist) revertants. Hence, the test material was classified as negative in the Ames test under the
experimental conditions used.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.