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Diss Factsheets
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EC number: 240-540-6 | CAS number: 16485-10-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008-08-12 to 2008-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: For justification of read across please refer to the attachment in IUCLID5 section 13.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Test material form:
- liquid: viscous
Constituent 1
Method
- Target gene:
- The V79 cells are exposed to the test item both with and without exogenous metabolic activation. At a defined time interval after treatment the descendants of the treated orginal population are monitored for the loss of functional HPRT enzyme.
HPRT (hypoxanthine- guanine phosphoribosyl transferase) catalyes the conversion of the nontoxic 6TG (6-thioguanine) to its toxic ribophosphorylated derivate. Therefore, cells defient HPRT due to a forward mutation are resistant to 6TG. These cells are able to proliferate in the presence of 6TG whereas the non-mutated cells die. However, the mutant phenotype requires a certain period of time before it is completely expressed. The phenotypic expression is achieved by allowing exponential growth of the cells for 7 - 9 days. The expression period is terminated by adding 6Tg to culture medium.
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: HAT-medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/ß-naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 150; 300; 600; 1200; 2400 µg/mL
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties and its relative non-toxicity to the cells.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- Migrated to IUCLID6: With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; MEM supplemented with 10 % FCS,
DURATION
- Exposure duration: First experiment: 4 hours; second experiment: 24 hours
- Expression time: 7 days
- Selection time: 8 days
SELECTION AGENT: 6-TG
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 1.5 x 10E06
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency;
OTHER EXAMINATIONS:
- Osmolarity: solvent control. 393 mOsm; Ethyl Panthenol/2400 µg/mL: 381
- pH: solvent control: 7.3; Ethyl Panthenol/2400 µg/mL: 7.3
OTHER: none - Evaluation criteria:
- A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
A mutgenic response is described as follows:
The test item is classified as mutagenic if it induces reproducibly with one of the concentrations a mutation frequency that is three times higher than the spontaneous mutation frequency in the experiment.
The test item is classfied as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutatant frequency is not observed.
However, in a case by case evaluation this decision depends on the level of the corresponding solvent control data. - Statistics:
- A linear regression was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT11 statistics software. The number of mutant colonies obtained for the groups treated with test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value is below 0.05. However, both, biological and statistical significance were considered together.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: no
- Water solubility: soluble
- Precipitation: no precipitation of the testitem up to the maximal concentration in all experiments.
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: A pre-test was performed according to the guidelines. Test item concentrations were chosen with regard to the purity of the test item (100.3 %) and its molecular weight (233.31 g/mol).
COMPARISON WITH HISTORICAL CONTROL DATA: no
ADDITIONAL INFORMATION ON CYTOTOXICITY: no - 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
In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
Therefore, DL-Ethyl Panthenol is considered to be non-mutagenic in this HPRT assay. - Executive summary:
- In a mammalian cell gene mutation assay (OECD 476, GLP), chinese hamster V79 cells cultured in vitro were exposed for 4 hours to DL-Ethyl Panthenol, at concentrations of 150, 300, 600, 1200, 2400 µg/mL in the presence and absence of mammalian metabolic activation S9 mix (rat liver). In a second test the chinese hamster V79 cell cultures were exposed to the same concentrations for 24 hours in the absence of metabolic activation. DL-Ethyl Panthenol was tested up to concentrations of 2400 µg/mL (approx 10 mM). No relevant cytotoxic effect was observed in the first experiment as relative cloning efficiency 1 did not go below 50 %. In the second experiment cytotoxicity was noted at 300 µg/mL and above. No substantial dose dependent increase of the mutation frequency exceeding the threshold of three times the mutation frequency of the corresponding solvent control occured with and without metabolic activation. Furthermore there was no dose dependent trend even below the threshold mentioned above as indicated by the missing statistical significance. Therefore, the data of this study are judged as non-mutagenic. The positive controls induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test and the activity of the metabolic activation system. This study is classified as acceptable. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.Therefore, DL-Ethyl Panthenol is considered to be non-mutagenic in this HPRT assay.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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