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EC number: 601-593-4 | CAS number: 119302-19-1
- 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:
- 13 October 1997 - 23 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guidelines 471, 472 and EU Method B.13/14 without deviations and GLP practices.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol
- EC Number:
- 601-593-4
- Cas Number:
- 119302-19-1
- Molecular formula:
- C23H37NO2
- IUPAC Name:
- (1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Epyrrol
- Substance type: Pure active substance
- Physical state: Solid, Off-white powder
- Analytical purity: No data
- Composition of test material, percentage of components: ~75% Main component, ~18% Other, ~7& other
- Lot/batch No.: GL-1291 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable in Ethanol (vehicle) at least 4 hours
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine-requiring S. typhimurium, and
Tryptophan-requiring E. 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: Agar Plates (0.9 cm) contained 25 mL glucose agar medium. During the test period the strains also contained 12.5 ug/plate biotin and 15 ug/plate histidine. The top agar was composed of Vogel-Bonner Medium E containing 0.6% (w/v) purified agar was heated to dissolve the agar. Samples of 3 mL top agar were transferred into 10 mL glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121 deg C.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Agar Plates (0.9 cm) contained 25 mL glucose agar medium. During the test period the strains also contained 15 ug/plate tryptophan. The top agar was composed of Vogel-Bonner Medium E containing 0.6% (w/v) purified agar was heated to dissolve the agar. Samples of 3 mL top agar were transferred into 10 mL glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121 deg C.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-fraction
- Test concentrations with justification for top dose:
- Without activation: 100, 333, 1000, 1800, 3330 ug/plate
With activation: 100, 333, 1000, 1800, 3330 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Saline and DMSO
- Justification for choice of solvent/vehicle: No data
Controls
- Untreated negative controls:
- yes
- Remarks:
- The vehicle of the test substance, being ethanol absolute.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: daunomycine and 2-aminoanthracene
- Remarks:
- See table below for a breakout of the positive control substances used for each strain
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
SELECTION AGENT (mutation assays): Incubation time
NUMBER OF CELLS EVALUATED: colony counting: The revertant coloniew (histidine independent c.q. tryptophan independent) were counted automatically with a Protos model 50000 colony counter or manually, if less than 40 colonies per plate were present.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - number of reverants - Evaluation criteria:
- The test substance is considered negative (not mutagenic) in the test if:
- The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
- The negative response should be reproducible in at least one independently repreated experiment.
The test substances is considered positive (mutagenic) in the test if:
- It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
- The positive response should be reproducible in at leaset one independently repreated experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- TA1537 without activation had a 2.4-fold increase in the number of revertant (His+) colonies, first exp only. TA98 induced a 2.0 fold, dose-related, increase in both experiments. TA1535, TA100 did not induce dose related increase, both exp.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- TA98 induced a 4.1 fold dose-related increases in the number of revertant (His+) colonies in Exp. 1. Strain TA100 induced a 3.0 fold dose-related increase in Exp. 1. Strain TA1535, and TA1537, did not induce a dose-related increase, both exp.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- WP2uvrA did not induce a dose-related increase in the number of revertent colonies, in both exp.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- WP2uvrA, did not induce a dose-related increase, both exp.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance did not precipitate in the top agar. Preceiptation of thes test substace on the plates weas not observed at the start or at the end of the incubation period in tester strain TA100 and WP2uvrA.
RANGE-FINDING/SCREENING STUDIES: (Experiment 1): The test substance was tested in the tester strains TA100 and WP2uvrA wtih concentration of 3, 10, 33, 100, 333, 1000, 3330, and 5000 µg/plate in the absence and presence of S9-mix.
(Experiment 2): Based on the toxicity data of the first range finding study and the first experiment, the following dose range finding was tested in the second experiment. Strains TA1535 and TA100 with and without activation were tested at concentrations of 100, 333, 1000, 1800, 2400 ug/plate. Strain TA1537 with activation were tested at concentrations of 100, 333, 1000, 1800, 3330 ug/plate and without activation were tested at concentrations of 33, 100, 333, 1000, 1300 ug/plate. Strain TA98 with and without activation were tested at concentrations of 100, 333, 1000, 1800, 3330 ug/plate. Based on the toxicity data of the first experiment, the following dose range was tested in the second experiement with the E. coli strain WP2uvrA with and without activation were tested at concentrations of 100, 333, 1000, 3330, and 5000 ug/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: All other concentrations, not present in the table below, and strain Wp2uvrA showed no reduction in the bacterial background lawn or showed no reduction in the number of revertants, which was less than the minimal value of the historical control data range.
The negative and strain-specific positive control values were within our laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1 Test Results:
Strain |
Dose ug/plate |
Without activation |
With Activation |
||
Bacterial background lawn |
Revertant colonies |
Bacterial background lawn |
Revertant colonies |
||
TA1535 |
1800 |
Slight |
-1 |
Slight |
-1 |
3330 |
Extreme |
Extreme 2 |
Extreme |
Extreme 2 |
|
TA1537 |
1000 |
Slight |
-1 |
-0 |
-1 |
1800 |
Extreme |
Extreme 2 |
Slight |
-1 |
|
3330 |
Absent |
Complete |
Extreme |
Extreme 2 |
|
TA98 |
3330 |
Moderate |
Extreme |
Moderate |
-2 |
-0= No reduction in the bacterial background lawn.
-1= no reduction in the number of revertant colonies, which was less than the minimal value of the historical control data range.
-2= Microcolonies
-3= Reduction in the number of revertant colonies, compared to the concentration of 1800 ug/plate.
Note: All other concentrations, not mentioned here, showed no reduction in the bacterial background lawn or in the number of revertant colonies, which was less than the minimal values of the historical control data range.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation S. typhimurium, strains TA1537 and TA98
positive with metabolic activation S. typhimurium, strains TA98 and TA100
negative without metabolic activation S. typhimurium, strains TA1535 and TA100; E. coli, strain WP2uvrA
negative with metabolic activation S. typhimurium, strains TA1535 and TA1537; E. coli, strain WP2uvrA
Based on the results of this study it was concluded that Epyrrol was mutagenic in the Salmonella typhimurium reverse mutation assay and Epyrrol was not mutagic in the Escherichia coli reverse mutation assay.
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