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EC number: 236-770-1 | CAS number: 13477-62-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
- AMES (OECD 471, GLP): negative (BASF1989; 40M0482/884148)
- HPRT test in CHO cells (OECD 476, GLP): negative (BASF2016; 50M0080/13M357)
- MNT in V79 cells (OECD 487, GLP): negative (BASF2017; 33M0080/13M358)
Additional information
Mutagenicity in bacteria
In the chosen key study for mutagenicity in bacteria acc. to OECD 471 and GLP, i.e. an AMES test, tetrahydro-2-isobutyl-4-methyl-2H-pyran was tested in a plate in a plate incorporation and preincubation test using the strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 up to a max. concentration of 5000 µg/plate with and without the addition of liver S9 mix from Aroclor 1254 induced rats (BASF1989; 40M0482/884148).
No increase in the number of his+ or trp+ revertants was observed up to cytotoxic concentrations of tetrahydro-2-isobutyl-4-methyl-2H-pyran either without S-9 mix or after the addition of a metabolizing system. According to these results, tetrahydro-2-isobutyl-4-methyl-2H-pyran is determined as non-mutagenic in the Ames test under the experimental conditions chosen.
Mutagenicity in mammalian cells
In the key study for mutagenicity in mammalian cells acc. to OECD 476 and GLP, tetrahydro-2-isobutyl-4-methyl-2H-pyran was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro (BASF2016; 50M0080/13M357). Two independent experiments were carried out, both with and without the addition of liver S9 mix from phenobarbital- and β-naphthoflavone induced rats (exogenous metabolic activation). According to initial range-finding cytotoxicity tests for the determination of the experimental doses and taking into account the cytotoxicity actually found in the main experiments, test concentrations were selected.
At least the highest concentrations evaluated for gene mutations (400 µg/ml) were clearly cytotoxic in the absence and the presence of metabolic activation. Tetrahydro-2-isobutyl-4-methyl-2H-pyran did not cause any relevant increase in the mutant frequencies either without S9 mix or after the addition of a metabolizing system in all valid experiments performed independently of each other. Thus, under the experimental conditions of this study, tetrahydro-2-isobutyl-4-methyl-2H-pyran is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.
Clastogenicity/Aneugenicity in mammalian cells
In the key study for cytogenicity in mammalian cells acc. to OECD 487 and GLP was assessed for its potential to induce micronuclei in V79 cells in vitro (BASF2017; 33M0080/13M358). Three independent experiments were carried out with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). According to an initial range-finding cytotoxicity test for the determination of the experimental doses and taking into account the cytotoxicity actually found in the main experiment, adequate test concentrations were selected. A sample of at least 1000 cells for each culture was analyzed for micronuclei, i.e. 2000 cells for each test group.
Cytotoxicity indicated by clearly reduced cell count (indicated by relative population doubling) or proliferation index (CBPI) was observed at least at the highest applied concentration of tetrahydro-2-isobutyl-4-methyl-2H-pyran in all experimental parts of this study. No biologically relevant increase in the number of micronucleated cells was observed either without S9 mix or after the addition of a metabolizing system. A dose-related increase in micronucleus rates with statistical significance and containing a single outlier value above the 95% control limit of our historical negative control data was observed in the 2nd experiment in the presence of metabolic activation. This finding was not confirmed in a repeat experiment and was considered biologically irrelevant. On the basis of the results of the present study, tetrahydro-2-isobutyl-4-methyl-2H-pyran did not cause any biologically relevant increase in the number of cells containing micronuclei.
Thus, under the experimental conditions described, tetrahydro-2-isobutyl-4-methyl-2H-pyran is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.
Justification for classification or non-classification
The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and therefore, a non-classification is warranted.
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