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EC number: 686-853-5 | CAS number: 46921-17-9
- 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:
- 12th June 2017 - 22nd December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP, Guidelines : OECD 201
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- This deviation is considered to have no impact on the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- IUPAC name not applicable
- Molecular formula:
- C16H33NO2
- IUPAC Name:
- IUPAC name not applicable
- Reference substance name:
- IUPAC name not applicable
- Molecular formula:
- C28H55NO3
- IUPAC Name:
- IUPAC name not applicable
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- Purity : 88,0% / Storage conditions : stored in closed cabinet away from light at room temperature (15-25°C).
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Five concentrations up to the water solubility limit were prepared and divided in four replicates. Three replicates were inoculated with algae strain and incubated in a phytotronic
chamber during 72h. the fourth replicate were used as colour control. After 24, 48 and 72 hours, optical density were measured (683 nm) to determine cells concentration in each replicate. An aliquot was taken in each concentration preparation at t0, t24h, t48h and t72 for Lauryl Oxazoline quantification.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test item stock solutions (water solubility level) were prepared by dissolution of about 4 x 5 mg of Lauryl Oxazoline in 4 x 1000 mL of the test media. The solutions were prepared in 2 L glass bottle and shacked during about 24h. Then these preparations were decanted at about 5 minutes in separating funnel, filtered through 0.2 μm filter and mixed. This solution
was used as water solubility level and diluted in media to prepare several dilutions. The pH of this solutions was 7.9. Test media solution pH was between 6 and 9 considered as appropriate for a normal life of test organisms.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Culture conditions :
Temperature: 23°C ± 2°C. Light: continuous, with plant growth specific spectra fluorescent bulb, between about 4440 and 8880 Lux. Freshwater (reconstituted from salts). The algae are maintained at exponential growth rate by adding aliquots of algal culture to fresh reconstituted water samples weekly.
Origin :
Culture at SGS Multilab Rouen, strain from SAG Gottingen collection (ID n° 61.81).
Study design
- Test type:
- static
- Water media type:
- freshwater
- Remarks:
- reconstituted from salts
- Limit test:
- no
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- The test solutions at T0, T24h, T48h and T72h were sampled (volume: 200mL), extracted and quantified immediately according to the validated method.
- Post exposure observation period:
- Not applicable
Test conditions
- Test temperature:
- 23,7 to 24,9°C. The test was carried out in a phytotronic incubator at 23°C controlled at ± 2°C (temperature was recorded automatically by Evisense Temperature Center).
- pH:
- Test media solution pH was between 6 and 9 considered as appropriate for a normal life of test organisms. pH Variation in control solutions (pH units) : 0.4. Criteria : ≤ ± 1.5.
- Nominal and measured concentrations:
- Nominal concentrations:
The definitive test was performed with five concentrations up to water solubility limit (SL) and with a dilution factor of 2 (SL, SL/2, SL/4, SL/8, SL/16).
SL = 0,500 mg/L ;
SL/2 = 0,250 mg/L ;
SL/4 = 0,125 mg/L ;
SL/8 = 0,0625 mg/L ;
SL/16 = 0,03125 mg/L.
Measured concentrations (T0h):
SL = 0,5892 mg/L ;
SL/2 = 0,2863 mg/L ;
SL/4 = 0,1382 mg/L ;
SL/8 = 0,0709* mg/L ;
SL/16 = 0,0419 mg/L.
Measured concentrations (T24h):
SL = 0,3724 mg/L ;
SL/2 = 0,1706 mg/L ;
SL/4 = 0,1012 mg/L ;
SL/8 = 0,0401 mg/L ;
SL/16 = 0,0122 mg/L.
Measured concentrations (T48h):
SL = 0,2847 mg/L ;
SL/2 = 0,0420 mg/L ;
SL/4 = 0,0095 mg/L ;
SL/8 =SL/16 =
Measured concentrations (T72h):
SL = 0,0638 mg/L ;
SL/2 =SL/4 = SL/8 = SL/16 =
LOQ = 0.01 mg/L
*Extrapolated value, measured concentration were unvalidated. - Details on test conditions:
- - No. of organisms per vessels : 5 000 to 10 000 cells per mL
- No. of vessels per concentration (replicate) : 5
No. of vessels per control : 7 (A control (7 replicates) were performed at the same time with test media only. One replicate was used for quantification purpose only (800 to 1000 mL)).
- Photoperiod : continuous light
- Source/preparation of dilution water : prepared as described in OECD 201 test guideline - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (99,99%)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks:
- and EC10
- Effect conc.:
- ca. 0.046 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- (see tables below in the section : "Any other information on results incl. tables")
- Reported statistics and error estimates:
- (see tables below in the section : "Any other information on results incl. tables")
Any other information on results incl. tables
Growth rate and yield Inhibition per concentration :
Nominal concentrations (mg/L) | Growth rate (day-1) | Growth inhibition (%) | Yield (cells/mL) | Yield inhibition (%) |
Media control | 1.8899 | 0.0 | 1378604 | 0.0 |
SL | 0.3364 | 82.2 | 8845 | 99.4 |
SL/2 | 1.0522 | 44.3 | 123750 | 91.0 |
SL/4 | 1.6076 | 14.9 | 598497 | 56.6 |
SL/8 | 1.7487 | 7.5 | 925395 | 32.9 |
SL/16 | 1.8346 | 2.9 | 1183246 | 14.2 |
Reported statistics and error estimates / NOEC and LOEC determination for growth inhibition (using Statgraphics(R)) :
Results of nominal distribution for growth rate:
Test item nominal concentration (mg/L) | Effectif | Average | Standard-deviation | Skewness | kurtosis | Normal distribution |
Control | 6 | 1.890 | 0.044 | 0.060 | -1.044 | yes |
SL/16 | 3 | 1.835 | 0.078 | 1.193 | - | yes |
SL/8 | 3 | 1.749 | 0.097 | 0.680 | - | yes |
SL/4 | 3 | 1.608 | 0.067 | 0.713 | - | yes |
SL/2 | 3 | 1.052 | 0.192 | 0.996 | - | yes |
SL | 3 | 0.336 | 0.062 | -0.653 | - | yes |
Test of Levene for growth rate :
Test | Probability | Target probability | Homoscedasticity | |
Levene test | 0.7098 | 0.6253 | >= 0.05 | Yes |
Data were checked for distribution compatible with ANOVA analysis.
Test of ANOVA for growth rate :
ANOVA TABLE | Square sum | Dof | Average square | F | Probability | Target probability | Homogeneous groups |
Inter group | 6.1232 | 5 | 1.2246 | 140.05 | 0 | >= 0.05 | No |
Intra group | 0.1312 | 15 | 0.0087 | - | - | - | - |
Total | 6.2544 | 20 | - | - | - | - | - |
As ANOVA analysis do not lead to conclude to homogeneous groups, an effects was detected in relation to growth rate. A Tukey HSD pairwise test was made to find homogeneous groups.
Test of Tukey HSD pairwise for growth rate :
Contrast | Difference | +/- limits | Homogeneous group |
Control - SL/16 | 0.0553 | 0.2153 | Yes |
Control - SL/8 | 0.1411 | 0.2153 | Yes |
Control - SL/4 | 0.2823 | 0.2153 | No |
Control - SL/2 | 0.8376 | 0.2153 | No |
Control - SL | 1.5535 | 0.2153 | No |
SL/16 - SL/8 | 0.0858 | 0.2487 | Yes |
SL/16 - SL/4 | 0.2270 | 0.2487 | Yes |
SL/16 - SL/2 | 0.7823 | 0.2487 | No |
SL/16 - SL | 1.4982 | 0.2487 | No |
SL/8 - SL/4 | 0.1412 | 0.2487 | Yes |
SL/8 - SL/2 | 0.6965 | 0.2487 | No |
SL/8 - SL | 1.4124 | 0.2487 | No |
SL/4 - SL/2 | 0.5553 | 0.2487 | No |
SL/4 - SL | 1.2712 | 0.2487 | No |
SL/2 - SL | 0.7159 | 0.2487 | No |
Tukey HSD pairwise analysis leads to conclude that there was probably not difference between control condition and SL/8 (NOEC = 0.0278 mg/L) but detected a significant difference between control condition and SL/4 (LOEC = 0.0622 mg/L)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Ecotoxicity test of Lauryl Oxazoline on Pseudokirchneriella subcapitata fulfils the requirements of OECD test No. 201 to determine EC50y-72h = 0.046 mg/L [0.034 - 0.060] mg/L.
- Executive summary:
Objective
The scope of this study was, in compliance with the principles of Good Laboratory Practices
(GLP), to determine the acute toxicity of Lauryl Oxazoline on Pseudokirchneriella subcapitata
(Algae) in a 72-hours test.
Method Summary
Five concentrations up to the water solubility limit were prepared and divided in four
replicates. Three replicates were inoculated with algae strain and incubated in a phytotronic
chamber during 72h. the fourth replicate were used as colour control. After 24, 48 and 72
hours, optical density were measured (683 nm) to determine cells concentration in each
replicate. An aliquot was taken in each concentration preparation at t0, t24h, t48h and t72 for
Lauryl Oxazoline quantification.
A control (6 replicates) was performed at the same time with test media only.
Lauryl Oxazoline BPL16 -0047.001 Based on measured concentrations ErC50 -72h
[Confidence limits 95%]
0.146 mg/L
[0.133 - 0.160] mg/L
ErC10 -7h2h
[Confidence limits 95%]
0.046 mg/L
[0.037 - 0.057] mg/L
EyC50 -72h
[Confidence limits 95%]
0.046 mg/L
[0.034 - 0.060] mg/L
EyC10 -72h
[Confidence limits 95%]
0.013 mg/L
0.006 - 0.023] mg/L
NOECy 0.0135 mg/L LOECy 0.0278 mg/L ECX-72h: Effective Concentration corresponding to X% of mobility inhibition in the 72 -hours test
r : growth rate
y : growth yield
NOEC : No observed Effect concentration
LOEC : Lowest Observed Effect Concentration
Conclusion
Ecotoxicity test of Lauryl Oxazoline on Pseudokirchneriella subcapitata fulfils the
requirements of OECD test No. 201 to determine EC50y-72h = 0.046 mg/L [0.034 - 0.060]
mg/L.
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