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EC number: 457-810-6 | CAS number: -
- 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:
- 27 April to 26 May 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 471 without any deviation. The substance is adequately identified. Therefore full validation applies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- LEMI operating procedure MB08/45, version 1997
- Deviations:
- yes
- Remarks:
- 2-Aminoanthracene was used as the sole indicator of the efficacy of the S9-mix. No information on the characterisation of S9 with a mutagen that requires metabolic activation by microsomal enzymes has been included in the report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Directive 2000/32/EC
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-12-16/ Signed on 2005-03-11
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 457-810-6
- EC Name:
- -
- Cas Number:
- 854737-08-9
- Molecular formula:
- C11 H18 O2
- IUPAC Name:
- 5-hept-6-enyloxolan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless liquid
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Date of reception: 19 April 2005
Method
- Target gene:
- Salmonella typhimurium histidine (his) reversion system and the Escherichia coli tryptophan (trp) reversion system
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: MOLTOX TM (POB Box 1189 - 157 Industrial Park Dr - Boone, NC 28607 -USA)
- method of preparation of S9 mix : not detailed
- concentration of S9 in the final culture medium: S9-fraction 10% v/v was prepared from liver homogenates of Sprague Dawley rat induced with Aroclor 1254 - Test concentrations with justification for top dose:
- Cytotoxicity test (plate incorporation): 50, 150, 500, 1500 and 5000 μg/plate, with or without metabolic activation in S. typhimurium TA 100.
Mutagenicity test:
- Assay No. 1 (plate incorporation):
50, 150, 500, 1500 and 5000 μg/plate, with or without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (uvr A-)
Assay No. 2 (pre-incubation): 50, 150, 500, 1500 and 5000 μg/plate, with or without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (uvr A-) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Test substance preparation:
The highest concentration studied is 5 000 μg/plate. A solution at 500 mg/mL is prepared with acetone (Merck - Ref 14 - Lot K13208414). The test substance is stable in solvent used, under similar assay conditions, according to the sponsor.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: Diammine Dichloride: 1 µg/plate for E.Coli. Beta propiolactone: 50 µg/plate for TA1535
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: Strains of Salmonella typhimurium and Escherichia coli are obtained from "Unité de Programmation Moléculaire et Toxicologie Génétique" (CNRS UA 144) (Institut Pasteur).
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation
DURATION
- Preincubation period: Pre-incubation assay where the test substance was preincubated with the test strain, and 500 μL of S9-mix fraction for 1 hour at 37° C prior to mixing with the overlay agar and pouring onto the surface of the minimal agar plate.
- Exposure duration: Plates were incubated at 37 °C over a 48 hour period
NUMBER OF REPLICATIONS: 3 plates/dose for all groups
DETERMINATION OF CYTOTOXICITY
- Method: reduced number of spontaneous reversions indicating the bacteriostatic activity.
- OTHER:
- Checking strains: The genotype of bacterial strains was checked for Histidine and tryptophan requirements; Loss of cell wall LPS (rfa mutation) measuring crystal violet inhibition for Salmonella typhimurium strains; Ampicillin resistance for the strains which have the pKM 101 plasmide; Δuvr B mutation i.e. U.V.B sensitivity for Salmonella typhimurium and Δuvr A mutation i.e. U.V.A sensitivity for Escherichia coli; Spontaneous revertant rate
- After a 48 hour incubation period at 37° C, revertant colonies per plate are counted (n = 3).
- Sterility tests: The highest concentration and dilutions of the test substance (100 μL) were tested for sterility.
- Data were presented as the number of revertant colonies (mean ± standard deviation) per plate. The following ratio was calculated: R = Number of revertant colonies in the presence of the product / Number of revertant colonies in the absence of the product. - Evaluation criteria:
- The result of the test is considered as negative if the revertant number is below three fold the number of spontaneous reversions, for TA 1535 and TA 1537 strains, and below two fold the number of spontaneous reversions for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101) strains with and/or without metabolic activation.
The validity criteria are as follows :
- bacteriostatic activity of the highest concentration shall be equal to or less than 75 %, - the spontaneous reversion rate of the absolute negative control shall comply with the laboratory’s historical control data.
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with laboratory’s historical control data.
The result of the test is considered positive if a concentration – related increase is obtained in one, or several of the 5 strains, with and/or without metabolic activation; a mutagenic effect is taken into account for a given concentration of the test substance if the number of revertant colonies is at least two fold that of spontaneous revertant colonies number for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101), and three fold for TA 1535 and TA 1537.
All results must be confirmed in an independent experiment. - Statistics:
- None
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- BACTERIOSTATIC ACTIVITY CONTROL (STRAIN TA 100)
A bacteriostatic activity of 60.5 % is observed in the presence of the test substance 5 000 μg/plate (the maximun acceptable level is 75 %). The test substance is tested at the following doses 5 000, 1 500, 500, 150 and 50 μg/plate.
HISTORICAL CONTROL DATA
- See historical control table in "Attached background material" section
MUTAGENICITY RESULTS
There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental historic values obtained in the laboratory.
There is no evidence of any increase in the number of revertant colonies in the presence of the test substance (5000, 1500, 500, 150, 50 μg/plate) without and with metabolic activation for bacterial strains in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101).
Results were confirmed in a second independent experiment.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the presence of the test substance at 5 000 μg/plate we observe for all bacterial strains a significant decrease of the number of spontaneous reversions which confirmed the bacteriostatic activity observed at this dose.
OTHERS:
Sterility test did not show any bacterial growth in presence of all substance doses / S9 mix.
Genotoxicity testing: see tables in "Attached background material" section.
Applicant's summary and conclusion
- Conclusions:
- Under the test condition, test substance is not mutagenic with and without metabolic activation in S. typhimurium strains TA1535, TA1537, TA98 and TA100, and E.coli WP2uvrA.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli (WP2uvrA) were exposed to test substance at the following concentrations.
Assay No. 1 (plate incorporation method): 50, 150, 500, 1500 and 5000 μg/plate, with or without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (uvr A-)
Assay No. 2 (pre-incubation method): 50, 150, 500, 1500 and 5000 μg/plate, with or without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (uvr A-)
Metabolic activation system used in this test was10 % (v/v) S9 mix; S9 fraction prepared from liver homogenates of rats induced with Aroclor 1254. Negative, vehicle and positive control groups were also included in mutagenicity tests.
In the presence of the test substance at 5 000 μg/plate we observe for all bacterial strains a significant decrease of the number of spontaneous reversions which confirmed the bacteriostatic activity observed at this dose.
There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental historic values obtained in the laboratory..
There is no evidence of any increase in the number of revertant colonies in the presence of the test substance (5000, 1500, 500, 150, 50 µg/plate) without and with metabolic activation for bacterial strains in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101).
Results were confirmed in a second independent experiment.
Under the test conditions, test substance is not considered as mutagenic with and without metabolic activation in these bacterial systems.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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