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EC number: 219-868-9 | CAS number: 2556-10-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 March 2000 - 26 May 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This information is used for read across to Hyacinth body.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Result derived from read across is sufficiently reliable because all Annex XI criteria are met.
- Justification for type of information:
- The read across justification is presented in the genetic toxicity endpoint summary and the accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the results of the OECD TG 471 study 9Ames) for read-across substance Hyacinth body #3, Hyacinth body is not considered to be mutagenic in bacteria.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [2-(1-propoxyethoxy)ethyl]benzene
- EC Number:
- 231-327-9
- EC Name:
- [2-(1-propoxyethoxy)ethyl]benzene
- Cas Number:
- 7493-57-4
- Molecular formula:
- C13H20O2
- IUPAC Name:
- [2-(1-propoxyethoxy)ethyl]benzene
1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix
- Test concentrations with justification for top dose:
- 50 to 5000 μg per plate in the presence and absence of S9 mix.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: according to guidelines
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: standard plate incorporation
DURATION: Exposure duration: 48h -72h
NUMBER OF REPLICATIONS: The experiment was performed in triplicate and repeated in full after an interval of at least 3 days.
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn measurement and reduction in revertant colonies compared to the controls - Statistics:
- Estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was done, using a X2-test (Mohn and Ellenberger,1977).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%): A historical overview of the revertant frequencies of the strains used in the Freiburger Labor fur Mutagenitätsprüfung for the years 1998 to 2000.
Mix: -S9 +S9 -S9 +S9
strain: spontaneous /solvent cont./ spontaneous/ solvent cont
TA1535: 31±11 (13/58) 30±11 (10/62) 19±6 (9/27) 18±6 (9/28)
TA1537: 11±4 (5/20) 11±4 (6/21) 16±5 (9/29) 16±5 (9/29)
TA98: 30±8 (18/47) 29±8 (19/50) 40±10 (21/63) 38±9 (23/62)
TA100: 150±35 (89/226) 138±29 (94/205) 139±38 (88/238) 133±38 (79/222)
TA102: 280±37 (218/359) 269±38 (163/337) 306±45 (237/400) 298±46 (207/404)
The historical data of positive controls are given in the form: strain, mutagen (concentration of mutagen in μg/plate), mean of revertants per plate (minimum/maximum). The data of test without S9 are: TA1535, NaN3 ( 0.7), 513±130 (242/688); TA1537, 9-AA (50), 278±97 (131/529); TA98, 2-NF (2.5), 353±113 (190/632); TA100, NaN3 ( 0.7), 427±90 (312/665); TA102, Mitmomycin C (0.15) 820±151 (577/1061). The data of the tests with lot KH3799 of S9 are: TA1535, 2-AA (1.5), 547±205 (310/1118); TA1537, 2-AA (1.5), 299±157 (100/543); TA98, 2-AA (0.7), 919±458 (319/2243); TA100, 2-AA (0.7), 854±336 (402/1955); TA102, 2-AA (1.5), 1116±337 (610/1799). Additional data of the tests with lot KH3799 of S9 are: TA100, B(a)P (5.0), 869±100 (736/976)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the presence and absence of S9-mix Resedafol / Corps 302 was bacteriotoxic towards the strains TA1535 at 1500 µg/plate and towards the strains TA98, TA100, TA102, and TA1537 at 5000 μg/plate.
Any other information on results incl. tables
The number of spontaneous revertants observed using each of the five strains was close to those previously established in the laboratory and was within the range obtained by Ames et al. (1975) as well as reported by De Serres and Shelby (1979). The results with the positive control substances confirmed the known reversion properties and specificity of the tester strains as well as the fall activity of the metabolizing system.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study according to OECD TG 471 (Ames test), Hyacinth body #3 was determined to be not mutagenic.
- Executive summary:
The mutagenic activity of Hyacinth body #3 was evaluated in accordance with OECD 471 guideline (Ames test) and according to GLP principles, therefore a Klimisch 1 rating was assigned. The test was performed as a standard plate incorporation assay, both in the absence and presence of S9-mix up to and including 5000 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of revertants and background lawn, was observed. In the presence and absence of S9-mix, Hyacinth body #3 was toxic towards the strains TA1535 at 1500 µg/plate and towards the strains TA98, TA100, TA102, and TA1537 at 5000 μg/plate. No precipitation was observed at any of the concentrations. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 TA102), both in the absence and presence of S9 -metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study, it is concluded that Hyacinth body #3 is not mutagenic.
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