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EC number: 807-422-1 | CAS number: 66918-01-2
- 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
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:
- 2015-08-06 to 2015-10-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to international methods and GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF (12-Nousan-No.8147,2-7-7-1, 24 November, 2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- EC Number:
- 807-422-1
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
- Details on sampling:
- The cell numbers were determined at 24, 48 and 72 hours after starting the test by manual cell counting using a microscopic method with a counting chamberThe cell numbers were determined at 24, 48 and 72 hours after starting the test by manual cell counting using a microscopic method with a counting chamber
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Reconstituted algal growth medium (OECD medium, according to OECD 201) was used as dilution water for the test item and in both the range finding and definitive tests.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Strain number: 61.81 SAG (identical strains: CCAP 278/4; UTEX 1648; ATCC 22662).
Justification of species: The species of Pseudokirchneriella subcapitata used, being a fast-growing species, is convenient for culturing and testing and is a recommended species by relevant guidelines.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- The cell numbers were determined at 24, 48 and 72 hours after starting the test by manual cell counting using a microscopic method with a counting chamber. Microscopic observation of the algal cells in each concentration and in the control was performed (at 24h, 48h and 72h) to detect any abnormal appearance of the algae.
Test conditions
- Hardness:
- No information
- Test temperature:
- Temperature range in flasks : 22.8 – 22.9 °C
Temperature range within the climate chamber : 22.5 - 23.3 °C - pH:
- 7.71-8.64
- Dissolved oxygen:
- No information
- Salinity:
- No information
- Nominal and measured concentrations:
- Because the test items is very poorly soluble in water, a test solution was prepared according to OECD method No. 23.
Nominal concentration: 100 mg/L
The non-dissolved test material was removed to obtained the 100% staturated solution. - Details on test conditions:
- Test performance
The exposure time was 72 hours. The test was started (0 hours) by inoculation of a biomass of approximately 104 algal cells per mL test medium.
The test was performed with six replicates per test concentration and six replicates in the control group as well. Volumes of 100 mL test solution per replicate in 250 mL Erlenmeyer flasks were continuously shaken by a laboratory orbital shaker to keep algae in suspension. The flasks were covered with air-permeable stoppers.
The algal culture flasks were continuously illuminated. The light intensity at the position occupied by algal culture flasks during the test was about 8141 lux (equivalent to ~110 µE/m2/s) - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- EbC50
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- ErC50
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield (EyC50)
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Because significantly toxic response was not observed during the preliminary concentration Range-Finding Test, only one test concentration at the solubility level of the Test Item in the test medium (100 % saturated solution) and one control group was tested in a Limit-Test.
The ErC50, EbC50 and EyC50 values of the Test Item were determined from the raw data.
Statistical comparisons of biomass, average specific growth rates and yield in control and in treated groups were carried out using 2 Sample t-Test ( = 0.05) by TOXSTAT software.
For the determination of the LOEC and NOEC, the calculated mean biomass, growth rates and yield at the test concentrations were tested on significant differences to the control values by 2 Sample t-Test ( = 0.05) by TOXSTAT software.
Any other information on results incl. tables
Average Specific Growth Rates (µ)
The results of the statistical evaluation show that the 0-72 h average specific growth rate was not statistically significantly different from the untreated control value, accordingly the No Observed Effect Concentration (NOEC) was determined as 100 % saturated solution.
Growth rate (µ) and Percentage inhibition of µ during the Test Period
Growth rate µ and % inhibition of µ |
||||||
0 - 24 h | 0 - 48 h | 0 -72 h | ||||
Test Group | µ | % | µ | % | µ | % |
Control | 0.0589 | 0.0 | 0.0592 | 0.0 | 0.0586 | 0.0 |
100 % saturated solution | 0.0573 | 2.6 | 0.0584 | 1.4 | 0.0583 | 0.5 |
Areas under the Growth curves
The results of the statistical evaluation show that the 0-72 h areas were not statistically significantly different from the untreated control value, accordingly the No Observed Effect Concentration (NOEC) was determined as 100 % saturated solution.
Area under the growth curves (A) and Percentage inhibition of A during the Test Period
Areas under the Growth curves (A) and % inhibition of A |
||||||
0 - 24 h | 0 - 48 h | 0 -72 h | ||||
Test Group | A | % | A | % | A | % |
Control | 38.0 | 0.0 | 270.0 | 0.0 | 1266.0 | 0.0 |
100 % saturated solution | 36.0 | 5.3 | 258.0 | 4.4 | 1230.0 | 2.8 |
Yield
The results of the statistical evaluation show that the 0-72 h yield was not statistically significantly different from the untreated control value; accordingly the No Observed Effect Concentration (NOEC) was determined as 100 % saturated solution.
Yield (Y) and Percentage Inhibition of Y during the Test Period
Test Group |
Yield (Y) and % inhibition of Y (0 -72 h) | ||
Y | % | ||
Control | 66.8 | 0.0 | |
100% saturated solution | 65.5 | 2.0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- according to the test guidelines
- Conclusions:
- The effect of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate Test Item was assessed on algal growth using the unicellular green alga Pseudokirchneriella subcapitata (formerly known as Selenastrum capricornutum), over an exposure period of 72 hours.
The 72h EbC50 value: > 100 % saturated solution (nominal)
The 72h ErC50 value: > 100 % saturated solution (nominal)
The 72h EyC50 value: > 100 % saturated solution (nominal)
The 72h NOEC: 100 % saturated solution (nominal)
The 72h LOEC: > 100 % saturated solution (nominal)
Based on the results of this study, the Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the Test Item in the test medium. - Executive summary:
The effect of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate was assessed on algal growth using the unicellular green alga Pseudokirchneriella subcapitata, over an exposure period of 72 hours. Because toxic response was not observed during the preliminary concentration range-finding test, a Limit Test was carried out using only one test concentrationat the limit of solubility of the Test Item in the test medium (100 % saturated solution) and one control group.The experiment was carried out without analytical support based on agreement with the Sponsor. The test design included six replicates at test concentration and six replicates for the untreated control. Statistical comparisons of biomass, average specific growth rates and yield in control and in treated groups were carried out using 2 Sample t-Test (a= 0.05) by TOXSTAT software. The ErC50, EbC50 and EyC50 values of the Test Item were determined directly from the raw data.
The 72h EbC50 value: >100 % saturated solution (nominal)
The 72h ErC50 value: >100 % saturated solution (nominal)
The 72h EyC50 value: >100 % saturated solution (nominal)
The72h NOEC: 100 % saturated solution (nominal)
The72h LOEC : >100 % saturated solution (nominal)
Based on the results of this study, the Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate had no toxic effect at saturation; the EC50results and the LOEC are higher than the solubility level of the Test Item in the test medium.
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