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EC number: 601-596-0 | CAS number: 119302-24-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 August - 30 September 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-
- EC Number:
- 601-596-0
- Cas Number:
- 119302-24-8
- Molecular formula:
- C29H48N2O4
- IUPAC Name:
- Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Pymorolac
- Physical state: Cream white solid
- Analytical purity: >95%
- Lot/batch No.: DGN105K1A
- Expiration date of the lot/batch: 01 January 2001
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark.
Constituent 1
Method
- Target gene:
- Thymidine kinase (TK) locus in L5178Y mouse lymphoma cells.
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: F10 complete culture medium consisted of Ham's F10 medium without thymidine and hypoxanthine (Gibco), supplemented with 10% (v/v) horse serum, L-glutamine (2mM) and penicillin/streptomycin (50 U/mL and 50 micro g/mL respectively).
Selective - Medium consisted of F10 complete culture medium, supplemented with 10% (v/v) horse serum and 5 micro g/mL TFT (sigma).
Non-selective - Medium consisted of F10 complete culture medium, supplemented with 10% horse serum.
- Properly maintained: Yes,
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: No data
- Periodically "cleansed" against high spontaneous background: No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Rat liver
- Test concentrations with justification for top dose:
- Without S9- 10, 25, 50, 100, 125, 250, 500, 625, 750 and 1000 micro g/mL; and
With S9- 10, 25, 50, 100, 125, 250, 500, 625, 750 and 1000 micro g/mL. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulphoxide.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- other: dimethylnitrosamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In exposition medium in the presence and absence of S-9 mix.
DURATION
- Preincubation period: 4 days
- Exposure duration: 3 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 9 days
- Fixation time (start of exposure up to fixation or harvest of cells): 3 days
SELECTION AGENT (mutation assays): Selective medium consisted of F10 complete culture medium, supplemented with 10% (v/v) horse serum and 5 micro g/mL TFT (Sigma).
STAIN (for cytogenetic assays): 0.5 mb/mL MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Sigma)
NUMBER OF REPLICATIONS: 4
NUMBER OF CELLS EVALUATED: 9.6 10E05 cells/concentration, containing 2500 cells
DETERMINATION OF CYTOTOXICITY
- Method: Cloning efficiency (CE)
OTHER EXAMINATIONS:
- Other: Mutation frequency - Evaluation criteria:
- The test substance was considered positive if:
- It induced at least a 3-fold increase in mutation frequency compared to the solvent control in a dose-dependent manner; and
- The results were reproducible in an independently repeated test.
The test substance was considered negative if:
- None of the tested concentrations showed mutant frequency of at least 3-fold compared to the solvent control.
- The results were confirmed in an independently repeated test.
A mutation assay was considered acceptable if:
- The absolute cloning efficiency of the solvent controls was >/= 50%.
- In at least seven of the eight doses of the test substance, an acceptable number of surviving cells (10E6) could be analysed for expression of the TK mutation.
- The spontaneous mutant frequency in the untreated or solvent control was < 10 per 10E5 clonable cells.
- The positive controls induced significant (at least 3-fold) increases in the mutant frequencies. - Statistics:
- Calculations of the CE was determined by dividing the number of empty wells by the total number of wells. This value was called P(0), the zero term of the Poisson distribution.
P(0) = number of empty wells/total number of wells;
CE = -ln P(0)/number of cells plated per well.
The calculations for mutation frequency (MF) was determined, as follows:
MF = {-ln P(0)/number of cells plated per well}/CE3
Mutation frequency was reported as the number of mutants per 10E5 surviving cells.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In the absence of S9-mix after 3 hours of treatment, the toxicity in the suspension growth was 47% at the test substance concentration of 333 micro g/mL compared to the suspension growth of the solvent control. Hardly any cell survival was observed at the test substance concentration of 1000 micro g/mL (3%).
In the absence of S9-mix after 3 hours of treatment, toxicity in the suspension growth was 31% at the test substance concentration of 333 micro g/mL compared to the suspension growth of the solvent control. Hardly any cell survival was observed at the test substance concentration of 1000 micro g/mL (6%).
In the absence of S9-mix after 24 hours of treatment, the toxicity in the suspension growth was 79% at the test substance concentration of 33 micro g/mL compared to the suspension growth of the solvent control. No cell survival was observed at test substance concentrations of 100, 333, and 1000 micro g/mL after 24 hours of treatment. - 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 experimental conditions the test substance is not mutagenic in the TK mutation test system.
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