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EC number: 273-868-3 | CAS number: 69103-01-1
- 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
- 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)
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-menth-1-en-8-yl acetate
- EC Number:
- 201-265-7
- EC Name:
- p-menth-1-en-8-yl acetate
- Cas Number:
- 80-26-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
- Reference substance name:
- Myrcenyl acetate
- EC Number:
- 214-262-0
- EC Name:
- Myrcenyl acetate
- Cas Number:
- 1118-39-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,1-dimethyl-5-methylenehept-6-en-1-yl acetate
- Reference substance name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-183-1
- EC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-04-5
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-184-7
- EC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-05-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- EC Number:
- 233-564-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- Cas Number:
- 10235-63-9
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexyl acetate
- Reference substance name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- EC Number:
- 208-546-3
- EC Name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- Cas Number:
- 532-87-6
- Molecular formula:
- C20H32
- IUPAC Name:
- 4-(5-methyl-1-methylenehex-4-en-1-yl)-1-(4-methylpent-3-en-1-yl)cyclohexene
- Reference substance name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- EC Number:
- 244-028-3
- EC Name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- Cas Number:
- 20777-47-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexyl acetate
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Cas Number:
- 150461-96-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Reference substance name:
- Tentative monoterpene diacetate
- IUPAC Name:
- Tentative monoterpene diacetate
- Reference substance name:
- Tentative oxygenated monoterpene acetate
- IUPAC Name:
- Tentative oxygenated monoterpene acetate
- Reference substance name:
- Tentative Diterpene hydrocarbon
- IUPAC Name:
- Tentative Diterpene hydrocarbon
- Reference substance name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- IUPAC Name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
- Specific details on test material used for the study:
- Identification: Neobergamate Forte
Appearance: Pale yellow liquid
Batch: SC00015234
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 07 November 2016 (expiry date)
Test item handling: Use amber glassware or wrap container in aluminum-foil
CAS Number: 69103-01-1
EC Number: 273-868-3
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- not specified
- Details on test solutions:
- The batch of Neobergamate Forte tested was a pale yellow liquid and not completely soluble in test medium at the loading rates originally prepared. No correction was made for the purity/composition of the test item. Information provided by the Sponsor indicated that the test item is a complex mixture composed of constituents with different water solubility. Due to the low aqueous solubility and complex nature of the test item for the purposes of the test, the test item was prepared as a Water Accommodated Fraction (WAF).
Test solutions were prepared separately at loading rates ranging from 1.0 to 100 mg/L, applying 24 hours of magnetic stirring. Thereafter, the resulting mixtures were allowed to stabilize for 1 hour. Subsequently, the Water Accommodated Fractions (WAFs) were siphoned off. 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 colourless.
After preparation, volumes of 110 mL were added to each replicate of the respective test concentration containing 2.2 mL of an algal suspension providing a cell density of 104 cells/mL. Subsequently, 0.66 mL HEPES were added to each replicate.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Pseudokirchneriella subcapitata, strain: NIVA CHL 1
Source: In-house laboratory culture.
Reason for selection: This system is a unicellular algal species sensitive to toxic items in the aquatic ecosystem and has been selected as an internationally accepted species.
Stock culture: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
Light intensity: 60 to 120 μE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm.
Stock culture medium: M1; according to the NPR 6505 (“Nederlandse Praktijk Richtlijn no. 6505”) formulated using Milli-RO water (tapwater purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with the following composition:
NaNO3 500 mg/L
K2HPO4.3H2O 52 mg/L
MgSO4.7H2O 75 mg/L
Na2CO3.10H2O 54 mg/L
C6H8O7.H2O 6 mg/L
NH4NO3 330 mg/L
CaCl2.2H2O 35 mg/L
C6H5FeO7.xH2O 6 mg/L
H3BO3 2.9 mg/L
MnCl2.4H2O 1.81 mg/L
ZnCl2 0.11 mg/L
CuSO4.5H2O 0.08 mg/L
(NH4)6Mo7O24.4H2O 0.018 mg/L
Pre-culture: 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 104 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was
measured immediately before use.
Pre-culture medium: Adjusted M2; Standard M2 according to the OECD 201 Guideline but with a larger amount of NaHCO3, the addition of HEPES buffer and a lower pH. This medium will be formulated using Milli-RO water and will have the following composition:
NH4Cl 15 mg/l
MgCl2.6H2O 12 mg/l
CaCl2.2H2O 18 mg/l
MgSO4.7H2O 15 mg/l
KH2PO4 1.6 mg/l
FeCl3.6H2O 64 μg/l
Na2EDTA.2H2O 100 μg/l
H3BO3 185 μg/l
MnCl2.4H2O 415 μg/l
ZnCl2 3 μg/l
CoCl2.6H2O 1.5 μg/l
CuCl2.2H2O 0.01 μg/l
Na2MoO4.2H2O 7 μg/l
NaHCO3 300 mg/l
HEPES buffer 6 mmol/l
Hardness (Ca+Mg) 0.24 mmol/l (24 mg CaCO3/l)
pH 7.1 ± 0.3
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- Continuously in a temperature control vessel. During the exposure period the temperature measured in the incubator was maintained between 21 and 22°C. Temperature remained within the limits prescribed by the study plan (21-24°C, constant within 2°C).
- pH:
- Measured at the beginning and at the end of the test in all test concentrations and the control. The pH was within the limits prescribed by the study plan (6.0-9.0, preferably not varying by more than 1.5 units)
- Nominal and measured concentrations:
- Neobergamate Forte: WAFs prepared at loading rates of 1.0, 3.2, 10, 32 and 100 mg/L.
Controls Test: medium without test item or other additives.
Replicates:
6 replicates of the control.
3 replicates of each test concentration.
1 extra replicate of each test concentration for sampling
purposes after 24 hours.
2 replicates of each test concentration without algae.
1 replicate of each test concentration without algae and without
HEPES buffer for TOC analysis.
At the start of the test, the actual test concentrations in the solutions incubated with algae were 0.53, 1.8, 5.4, 20 and 37 mg/L in WAFs prepared at 1.0, 3.2, 10, 32 and 100 mg/L, respectively. The measured concentrations decreased throughout the test duration and were at 27-29% of initial at the end of the test. A decrease in measured concentrations was also observed for samples without algae (29-49% of initial at the end of the test), indicating that the loss seen in the samples with algae was not due to adsorption to the increasing algal biomass but either chemical instability or evaporation into the minimum headspace. - Details on test conditions:
- Test duration: 72 hours
Test type: Static
Test vessels: 120 mL, all-glass, containing 110 mL of test solution, with minimum headspace and closed airtight.
Medium: Adjusted M2 medium for volatile test items
Cell density: An initial cell density of 1 x 104 cells/mL.
Illumination: Continuously using TLD-lamps with a light intensity within the range of 80 to 84 μE/m2/s.
Incubation: Capped vessels were distributed at random in the incubator and as such were daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 14 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval ranging from 12 to 17 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 45 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval ranging from 4.2 to 10 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Given that only a fraction of the total mass of a multi-component substance may be present in the WAF, that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole and that the test was performed in airtight vessels to prevent loss due to volatilization, the effect parameters were based on loading rates initially prepared.
Under the conditions of the present study with Pseudokirchneriella subcapitata, Neobergamate Forte reduced growth rate of this fresh water algae species significantly in WAFs prepared at 32 mg/L and higher.
The EL10 for growth rate inhibition (72h-ERL10) was 14 mg/L with a 95% confidence interval ranging from 12 to 17 mg/L.
The EL10 for yield inhibition (72h-EYL10) was 7.4 mg/L with a 95% confidence interval ranging from 4.2 to 10 mg/L.
The EL50 for growth rate inhibition (72h-ERL50) was 45 mg/L with a 95% confidence interval ranging from 41 to 49 mg/L.
The EL50 for yield inhibition (72h-EYL50) was 18 mg/L with a 95% confidence interval ranging from 15 to 23 mg/L.
The 72h-NOEL for growth rate inhibition was 10 mg/L and the NOEL for yield inhibition was 3.2 mg/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the present study with Pseudokirchneriella subcapitata, Neobergamate Forte reduced growth rate of this fresh water algae species significantly in WAFs prepared at 32 mg/L and higher.
The EL10 for growth rate inhibition (72h-ERL10) was 14 mg/L with a 95% confidence interval ranging from 12 to 17 mg/L.
The EL50 for growth rate inhibition (72h-ERL50) was 45 mg/L with a 95% confidence interval ranging from 41 to 49 mg/L.
The 72h-NOEL for growth rate inhibition was 10 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 EL50 and EL10 based on growth rate are used for classification purposes, which were determined in this study to be 45 mg/L and 14 mg/L respectively.
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