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EC number: 944-251-2 | CAS number: -
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 June - 03 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
- EC Number:
- 246-099-6
- EC Name:
- 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
- Cas Number:
- 24237-01-2
- Molecular formula:
- C11H20O
- IUPAC Name:
- 2-butyl-4,6-dimethyl-3,6-dihydro-2H-pyran
- Reference substance name:
- 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
- EC Number:
- 246-098-0
- EC Name:
- 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
- Cas Number:
- 24237-00-1
- Molecular formula:
- C11H20O
- IUPAC Name:
- 6-butyl-2,4-dimethyl-3,6-dihydro-2H-pyran
- Reference substance name:
- 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
- EC Number:
- 246-101-5
- EC Name:
- 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
- Cas Number:
- 24237-02-3
- Molecular formula:
- C11H20O
- IUPAC Name:
- 2-butyl-6-methyl-4-methylenetetrahydro-2H-pyran
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Material Identification (as stated in the report) : Gyrane
Appearance: Colourless to pale yellow liquid
Batch: SC00016010
Expiry date: 27 August 2017
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The batch of GYRANE tested was a colorless to pale yellow liquid mixture and not completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test item.
Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in test medium. Thereafter, the resulting mixture was allowed to stabilize for one hour. Subsequently, the Saturated Solution (SS) was siphoned off and used as the highest test concentration. Lower concentrations were prepared by subsequent dilutions of the highest concentration in test medium. Due to the light sensitivity of the test item, preparation of test solutions was performed under dimmed light and used glassware was wrapped in aluminum foil. All final test solutions were clear and colorless.
After preparation, volumes of 120 mL were added to each replicate of the respective test concentration. Subsequently, 2.4 mL of an algal suspension was added to each replicate providing a cell density of 104 cells/mL.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Pseudokirchneriella subcapitata, strain: NIVA CHL 1 (In-house laboratory culture). This system is a unicellular algal species sensitive to toxic items in the aquatic ecosystem and has been selected as an internationally accepted species.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- none
Test conditions
- Nominal and measured concentrations:
- At the start of the test, the actual concentrations were 0.32, 1.1, 2.9, 11 and 36 mg/L in 1.0, 3.2, 10, 32 and 100% of the SS. The measured concentrations were at the level of 27-49% and at 7.4-15% of initial after 24 and 72 hours of exposure, respectively. The Time Weighted Average (TWA) concentrations were calculated to be 0.11, 0.43, 1.1, 3.4 and 13 mg/L, respectively, and used to determine the effect parameters
- Details on test conditions:
- A final test was performed based on the results of a preceding range-finding test. Six exponentially growing algal cultures were exposed to an untreated control, whereas three replicates per group were exposed to 1.0, 3.2, 10, 32 and 100% of the SS. The initial algal cell density was 104 cells/mL. The total exposure period was 72 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start, after 24 and 72 hours of exposure. The test item was suspected to be volatile and hence testing was performed in closed airtight vessels with minimum headspace and with adjusted medium.
- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.5 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.3 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Effects based on yield were also reported (see executive summary below and attached full study report). However, the preferred observational endpoint in the algal inhibition study is growth rate because it is not dependent on the test design (ECHA guidance Chapter R.7b v1.1). The EU CLP regulation (No 1272/2008 and its adaption 286/2011) also states that classification should be based on the ErC50. Thus only the effects based on growth rate are presented in the above "effects concentration" table.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the present study with Pseudokirchneriella subcapitata,
The EC10 for growth rate inhibition (72h-ERC10) was 4.3 mg/L with a 95% confidence interval ranging from 3.6 to 4.9 mg/L.
The EC50 for growth rate inhibition (72h-ERC50) was 8.5 mg/L with a 95% confidence interval ranging from 7.9 to 9.1 mg/L.
- Executive summary:
Pseudokirchneriella subcapitata, Fresh Water Algal Growth Inhibition Test with GYRANE.
The study procedures described in this report were based on the OECD guideline No. 201, 2006; Annex 5 corrected 28 July 2011. In addition, the procedures were designed to meet the test methods of theCommissionRegulation (EC) No 440/2008, Part C.3, 2008; Amended by EC No. 761/2009 and the OECD series on testing and assessment number 23, 2000.
The batch of GYRANE tested was a colorless to pale yellow liquid mixture and not completely soluble in test medium at the loading rate initially prepared.
A Saturated Solution (SS) was prepared at 100 mg/L and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.Due to the light sensitivity of the test item, preparation of test solutions was performed under dimmed light and used glassware was wrapped in aluminum foil. All final test solutions were clear and colorless.
A final test was performed based on the results of a preceding range-finding test. Six exponentially growing algal cultures were exposed to an untreated control, whereas three replicates per group were exposed to 1.0, 3.2, 10, 32 and 100% of the SS. The initial algal cell density was 104cells/mL.The total exposure period was 72 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start, after 24 and 72 hours of exposure. The test item was suspected to be volatile and hence testing was performed in closed airtight vessels withminimum headspace and with adjusted medium.
Samples taken from all concentrations were analyzed. At the start of the test, the actual concentrations were 0.32, 1.1, 2.9, 11 and 36 mg/L in 1.0, 3.2, 10, 32 and 100% of the SS. The measured concentrations were at the level of 27-49% and at 7.4-15% of initial after 24 and 72 hours of exposure, respectively. The Time Weighted Average (TWA) concentrations were calculated to be 0.11, 0.43, 1.1, 3.4 and 13 mg/L, respectively, and used to determine the effect parameters. The study met the acceptability criteria prescribed by the study plan and was considered valid.
The effect parameters obtained in this study are summarized
The EC10 for growth rate inhibition (72h-ERC10) was 4.3 mg/L with a 95% confidence interval ranging from 3.6 to 4.9 mg/L. The EC50 for growth rate inhibition (72h-ERC50) was 8.5 mg/L with a 95% confidence interval ranging from 7.9 to 9.1 mg/L. The EC10 for yield inhibition (72h-EYC10) was 2.8 mg/L with a 95% confidence interval ranging from 1.6 to 3.1 mg/L. The EC50 for yield inhibition (72h-EYC50) was 4.9 mg/L with a 95% confidence interval ranging from 4.1 to 11 mg/L. The 72h-NOEC for growth rate inhibition was 3.4 mg/L, while the NOEC for yield inhibition was 1.1 mg/L.
The preferred observational end point in the algal growth inhibition test is growth rate because it is not dependent on the test design (ECHA guidance Chapter R.7b v1.1). The EU CLP regulation (No 1272/2008 and its adaption 286/2011) also states that classification should be based on the ErC50. The preferred observational endpoint in long-term studies is the EC10 value because it is derived from the dose response curve. In contrast the NOEC strongly depends on the experiment design (e.g. the concentrations used in the test). Thus the 72-h EC50 and EC10 based on growth rate are used for classification purposes, which were determined in this study to be 8.5 mg/L and 4.7 mg/L respectively.
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