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EC number: 601-595-5 | CAS number: 119302-20-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2 August to 8 November 1999
- Reliability:
- 1 (reliable without restriction)
- 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
- Target gene:
- Thymidine kinase (TK)
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Mouse lymphoma cells were cultured in F10 complete culture medium. Cell density was preferably kept below 7 x 10^5 cells/mL. F10 complete culture medium consisted of Ham's F10 medium without thymidine and hypoxanthine (Gibco), supplemented with 10% (v/v) horse serum, L-glutamine (2 mM) and penicillin/streptomycin (50 U/mL and 50 µg/mL respectively).
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically "cleansed" against high spontaneous background: Yes, Prior to dose range finding and mutagenicity testing, the mouse lymphoma cells were grown for 1 day in F10 complete culture medium containing 10^-4 M hypoxanthine, 2x10^-7 M aminopterin and 1.6 x10^-5 M thymidine (HAT-medium) to reduce the amount of spontaneous mutants, followed by a recovery period of 2 days on medium containing hypoxanthine and thymidine only. After this period cells were returned to normal medium at least for 1 day before starting the experiment. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-fraction
- Test concentrations with justification for top dose:
- Within and without S9-mix: 0.1, 0.3, 0.56, 1.0, 1.8, 3.3, 5.6, and 10 µg/mL.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulphoxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- other: Dimethylnitrosamine (DMN)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium, F10 complete culture medium.
DURATION
- Exposure duration: 3 hours
- Expression time (cells in growth medium): 5 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): F10 complete culture medium, supplemented with 10% (v/v) horse serum and 5µg/mL TFT-Selection
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays): 0.5 mg/mL MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Sigma)
NUMBER OF REPLICATIONS: 9.6 x 10^5 cells/concentrations, each well containing 2500 cells in selective medium (TFT-selection)
NUMBER OF CELLS EVALUATED: 8 x 10^6 cells (10^6/mL), if test substance concentration was expected to be toxic, 16 x 10^6 cells (10^6/mL) were used per culture.
DETERMINATION OF CYTOTOXICITY
- Method: Cloning efficiency (CE) - Evaluation criteria:
- Colonies were divided in small and large colonies. Mutant cells that have suffered extensive genetic damage have prolonged doubling times and thus form small colonies. Less severe affected mutant cells have grown at rates similar to the parental cells and form large colonies. The small colonies can be associated with the induction of chromosomal mutations. The large colonies appeared to result from mutants with single gene mutation (substitutions, deletions of base-pairs) affecting the TK gene.
The small colonies are morphological dense colonies with a sharp contour and with a diameter less than a quarter of a well. The large colonies are morphological dense colonies with a hazy contour and with a diameter larger than a quarter of a well. - Statistics:
- Calculation of the cloning efficiency (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 (equation below).
The mutation frequency (MF) was expressed as the number of mutants per 10^5 surviving cells (equation below). - Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- 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 precipitated in the exposition medium at a concentration of 10 µg/mL.
RANGE-FINDING/SCREENING STUDIES: In the absence of S9-mix after 3 hours of treatment, the toxicity in the suspension growth was 32% at the test substance concentration of 10 µg/mL compared to the suspension growth of the solvent control.
In the absence of S9-mix after 24 hours treatment, the toxicity in the suspension growth was 34% at the test substance concentration of 10 µg/mL compared to the suspension growth of the solvent control.
In the presence of S9-mix after 3 hours treatment, no toxicity in the suspension growth was observed in all concentrations tested compared to the solvent control.
COMPARISON WITH HISTORICAL CONTROL DATA: Cloning efficiency of the remaining cells was comparable to the solvent controls even at the highest tested dose.
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the current test conditions the test substance was concluded to be non-mutagenic in mouse lymphoma L5178Y.
Reference
Both in the absence and presence of S9 -mix, after 3 hours treatment no significant reduction in the cell count was observed even in the highest dose level tested.
The test substance did not induce the mutant frequency at the TK locus either in the absence or in the presence of S9 -mix.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Test System | Application | Effect |
Mouse lymphoma L5178Y cells | In vitro Mammalian Cell Gene Mutation Test Mutagenicity - In vitro Mammalian Cell Gene Mutation Test Test substance exposure up to 24 hours within and without metabolic activation (S9-mix) in presence of Dimethylsulphoxide at 0.1, 0.3, 0.56, 1.0, 1.8, 3.3, 5.6, and 10µg/mL |
Negative |
Test System | Application | Effect |
S. typhimuriumTA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 | Ames - Bacterial Reverse Mutation Assay S. typhimurium TA 98 - with and without metabolic activation, S. typhimurium TA 100 - with metabolic activation, S. typhimurium TA 100 - without metabolica activation, and S. typhimurium TA 1535, TA 1537 and E. coli WP2uvrA |
Postive, Postive, Negative, Negative |
Justification for selection of genetic toxicity endpoint
Test substance is the same as registration substance (Pymordiol). Reliable test (Guideline and GLP) test data indicated that pymordiol is not genotoxic.
Justification for classification or non-classification
Taking into account all data, it is not expected that pymordiol exhibits any genotoxic/mutagenic potential.
Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP.
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.
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