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EC number: 246-922-9 | CAS number: 25378-22-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983-01-27 to 1983-02-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- While the study report does not provide a specific statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alkenes, C10/C11/C12/C13
- IUPAC Name:
- Alkenes, C10/C11/C12/C13
- Details on test material:
- This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Olefin 103 PQ/II
- Substance type: Alkenes C10/C11/C12/C13
- Physical state: Yellow liquid
Constituent 1
Method
- Target gene:
- Not specified
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 31.25, 62.5, 125, 250, 500, I000, 2000 or 4000 ug/plate for Ames assay; 0.01, 0.1., 0.5, 1.0 or 2.0 mg/mL for Saccharomyces cerevisiae gene conversion assay
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol/Tween 80
- Justification for choice of solvent/vehicle: Not provided
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Exposure duration: 48-72 hours; 3 days for Saccharomyces cerevisiae
- Evaluation criteria:
- Number of revertant colonies were counted in the Ames assay; number of prototrophic colonies were counted in the Saccharomyces cerevisiae gene conversion assay
- Statistics:
- Statistical methods, if employed, are not reported in the study
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation. The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation. - Executive summary:
Justification for Read Across
Several criteria justify the use of the read across approach to fill data gaps for single carbon number isomerised olefin substances using multiple carbon number isomerised olefin substance analogues. Studies indicate that changing the carbon number, the location of the double bond, or adding branching does not measurably alter the effects on mammalian health endpoints. There is a consistent toxicity potency pattern for isomerised olefins with a range of carbon numbers and they are considered to have minimal acute toxicity potential. Genotoxicity studies indicate that these materials are not mutagenic. No adverse systemic toxicity was observed in a 90-day repeated oral dose study in which rats were exposed to alkenes, C20-24. The toxicological profile of multiple carbon number isomerised olefins alkenes described above indicates a low hazard potential for human health. Since multiple carbon number isomerised olefins, alkenes is comprised of a mixture of single carbon number isomerised olefins, no significant toxicological differences are expected between the two categories of substance and read across between these two categories can be justified.
In a mutagenicity test procedure, three separate assays were used to determine the mutagenic potential of Olefin 103 PQ/11. Following an initial preliminary toxicity test, the main mutagenicity test was conducted in Salmonella typhimurium strains, TA1537, TA1535, TA100 and TA98 and Escherichia coli WP2 uvrA, both in the presence and absence of rat liver fraction S9, at 31.25, 62.5, 125, 250, 500, I000, 2000 or 4000 µg per plate. The cultures were incubated at 37°C for 48-72 hours before the revertant colonies were counted.
The test material was also tested in Saccharomyces cerevisiae. Liquid suspension cultures of log-phase cells of Saccharomyces cerevisiae JDI were dosed with of 0.01, 0.1., 0.5, 1.0 or 2.0 mg/mL, both in the presence and in the absence of rat liver S9 fraction. After 18 hours incubation at 30°C in the absence of S9 fraction, or 2hours at 37°C followed by 16 hours at 30°C in the presence of S9 fraction, the cultures were seeded onto the appropriate culture media for the selection of prototrophic colonies. After 3 days incubation at 30°C, the numbers of prototrophic colonies were counted.
Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation. The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9. Positive controls indicated that the test systems were working appropriately.
This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.
This study will influence the DNEL(s).
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