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EC number: 205-026-8 | CAS number: 131-53-3
- 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:
- 2017-12-18 - 2018-03-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- Adopted March 2006 and updated Annex 5 July 2011
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- March 2015
Test material
- Reference substance name:
- Dioxybenzone
- EC Number:
- 205-026-8
- EC Name:
- Dioxybenzone
- Cas Number:
- 131-53-3
- Molecular formula:
- C14H12O4
- IUPAC Name:
- 2-(2-hydroxybenzoyl)-5-methoxyphenol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name: 2,2’ -Dihydroxy-4-methoxybenzophenone
Batch/Lot Number: CM70314A1
Description: Yellow powder
Expiry Date: 14 March 2019
Purity: 99.8%
Storage Conditions: Room Temperature, protected from light
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10.0, 4.55, 2.07, 0.939 and 0.427% of a filtrate at a loading rate of 100 mg test item/L
- Sampling method: Control and test solution were sampled in dupblicate at the start of exposure and at 72h.
- Sample storage conditions before analysis: All samples were stored in amber glass bottles in the dark at a temperature of ≤ -18°C after sampling and before shipment.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The following approach was used taking into account aspects of ISO 14442 (2006), Water quality - Guidelines for algal growth inhibition tests with poorly soluble materials, volatile compounds, metals and waste water, and OECD 2000, Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment Number 23. ENV/JM/MONO(2000)6.
A stock solution at a nominal loading rate of 100 mg/L was prepared by adding 49.97 mg test item to 500 mL test medium. This stock solution stirred with a magnetic stirrer at 800 rpm for 46 h and 15 min at ambient temperature in the dark. After that, the stock solution was filtered, using a glass fibre filter with an average retention capacity of 0.4 µm (MN 85/220). The initial 100 mL of the filtrate were discarded. Visual inspection of the filtrate showed a clear solution without Tyndall effect.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 61.81
- Source: Sammlung von Algenkulturen, Albrecht-von-Haller-Institut, Universität Göttingen, Germany.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22.67 °C
- pH:
- 7.7 - 8.7
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass Erlenmeyer flasks (300 mL) covered by air-permeable lids
- Material, size, headspace, fill volume: 100±5 mL vill volume
- Initial cells density: 0.3 × 10^4
- Control end cells density: 97.24 × 10^4
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: 24h light / 0h dark
- Light intensity and quality: Mean 83.6 µE m–2s–1 - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.27 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.04 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.907 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.549 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities (for algal test):
In none of the concentration levels up to 4.55 % of a saturated solution at a loading rate of 100 mg/L were deformed and/or damaged algal cells observed during microscopic inspection. At the highest concentration level (10.0 % of a saturated solution at a loading rate of 100 mg/L) the cells were thin and small.
Validity criteria
The mean biomass increase in the control cultures was at least of 16 within the 72h test period (factor was 324.1), the mean coefficient of variation for section-by-section specific growht rates in the control cultures was less than 35% (9.5%) and the coefficient of variation of average specific growth rates during test period in replicate control cultures was less than 7% (0.8%)
The study is therefore considered to be valid. - Results with reference substance (positive control):
- Growth rate ErC50 (0–72 h): 0.952 mg/L
This value is within the range of the international ring test (ISO (2004). Therefore the results of this reference test are acceptable and the test conditions are reliable.
Any other information on results incl. tables
Table 1 Summary of biological results based on measured test item concentrations given in mg/L
|
Endpoints [mg test item/L] |
||||
Parameter |
EC10 |
EC20 |
EC50 |
NOEC |
LOEC |
Yield (95% cI) |
0.549 (0.454–0.622) |
0.652 (0.564–0.718) |
0.907 (0.846–0.957) |
0.471 |
1.12 |
Growth Rate (95% cI) |
1.04 (n.d.) |
1.11 (n.d.) |
1.27 (n.d.) |
0.471 |
1.12 |
cl: confidence limit
n.d.: not determined due to mathematical reasons or inappropriate data
Table 2: Summary of biological results based on nominal test item concentrations given in % of a filtrate at a loading rate of 100 mg test item/L
|
Endpoints [%a)] |
||||
Parameter |
EC10 |
EC20 |
EC50 |
NOEC |
LOEC |
Yield (95% cI) |
2.38 (1.91-2.71) |
2.78 (2.36-3.08) |
3.76 (3.48-3.98) |
2.07 |
4.55 |
Growth Rate (95% cI) |
4.13 (0.573-4.33) |
4.52 (3.87-4.56) |
5.36 (4.95-152) |
2.07 |
4.55 |
cl: confidence limit
a)% of a saturated solution at a loading rate of 100 mg/L
Table 3: Summary of measured concentrations at the beginning and at the end of the test.
Conc. |
Test period |
Nominal concentration |
Measured concentration |
% of measured initial (time 0 hours) concentration |
Geometric mean measured concentration over 72 h |
|
[d] |
[%a)] |
[mg test item/L] |
[%] |
[mg test item/L] |
Control |
0 |
0 |
n.d. |
– |
– |
C1 |
0 |
0.427 |
0.104 |
– |
– |
C2 |
0 |
0.939 |
0.226 |
– |
– |
C3 |
0 |
2.07 |
0.480 |
– |
– |
C4 |
0 |
4.55 |
1.132 |
– |
– |
C5 |
0 |
10.0 |
2.543 |
– |
– |
Control |
3 |
0 |
n.d. |
– |
n.d. |
C1 |
3 |
0.427 |
0.0989 |
95 |
0.101 |
C2 |
3 |
0.939 |
0.209 |
92 |
0.217 |
C3 |
3 |
2.07 |
0.463 |
96 |
0.471 |
C4 |
3 |
4.55 |
1.105 |
98 |
1.12 |
C5 |
3 |
10.0 |
2.403 |
94 |
2.47 |
LOQ = Limit of Quantification (0.07 mg/L)
n.d.: not determined, “Limit of Detection”(0.003 mg/L)
a)% of a saturated solution at a loading rate of 100 mg/L
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Expressed in terms of measured concentrations, the ErC50 for freshwater algae was 1.27 mg/L and ErC10 1.04 mg/L.
- Executive summary:
The acute toxicity of the Dioxybenzone to algae was tested according to OECD guideline 201 and GLP conditions.
A clear concentration-response relationship was observed for both biological parameters growth rate and yield during the exposure period.
The EbC50 of Raphidocelis subcapitata was determined to be 0.907 mg/L and EbC10 0.549 mg/L.
The ErC50 of Raphidocelis subcapitata was determined to be 1.27 mg/L and ErC10 1.04 mg/L.
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