Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12th June 2017 - 4th December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP, Guidelines : OECD 202
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 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- 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 daphnies were exposed in 50 mL solution of each replicate to fives concentrations up to water solubility limit : 0.003 – 0.0075 – 0.015 – 0.045 – 0.075 – 0.15 mg/L in test media.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- The test item stock solutions (water solubility level) were prepared by dissolution of about 5 mg of Lauryl Oxazoline in 1000 mL of the test media. The solution were prepared in 2 L glass bottle and shacked during about 24h. Then this preparation were decanted at about 5 minutes in separating funnel and filtered through 0.2 μm filter. This solution was used as water
solubility level and diluted in media to prepare several dilutions. The pH of these solutions were in the range 8.0-8.1. Test media solution pH was between 6 and 9 considered as appropriate for a normal life of test organisms.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna Straus. Daphnids less than 24 hours old and produced from parthenogenically reproducing brood female population. Origin : Culture at SGS Multilab Rouen.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- reconstituted from salts
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Lauryl Oxazoline were quantified at t0, t24h and t48h. Number of immobilized daphnids was recorded after 24h and 48h in all replicates.
- Post exposure observation period:
- Not applicable
Test conditions
- Test temperature:
- 19.6 to 19.9°C. The test was carried out in a thermostatic chamber at 20°C +/- 2°C in the dark (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 the test (pH units) : 0.1 (Criteria : ≤ ± 1.5).
- Dissolved oxygen:
- Dissolved oxygen at T48h (mg/L) : 7,9 (Criteria : ≥ 3).
- 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
Meaured concentrations T0 (mg/L) :
SL = 0.531
SL/2 = 0.270
SL/4 = 0.119
SL/8 = 0.058
SL/16 = 0.030
Meaured concentrations T24h before renewal (mg/L) :
SL = 0.269
SL/2 = 0.135
SL/4 = 0.049
SL/8 = 0.027
SL/16 = 0.010
Meaured concentrations T24h after renewal (mg/L) :
SL = 0.490
SL/2 = 0.243
SL/4 = 0.123
SL/8 = 0.062
SL/16 = 0.031
Meaured concentrations T48h (mg/L) :
SL = 0.289
SL/2 = 0.155
SL/4 = 0.082
SL/8 = 0.034
SL/16 = 0.016 - Details on test conditions:
- - Test vessels : 125mL glass flask
- Type : open
- Aeration : Slightly aerated
- No. of organisms per vessels : 5
- No. of vessels per concentration (replicate) : 4
- No. of vessels per control : 4
- Photoperiod : light/dark cycle 16/8 hours
- Source/preparation of dilution water : prepared as described in OECD 202 test guideline - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (99,99%)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Remarks:
- and EC10
- Effect conc.:
- ca. 0.106 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- (see tables below section : "any other information on results incl. tables")
- Reported statistics and error estimates:
- (see tables below section : "any other information on results incl. tables")
Any other information on results incl. tables
Toxicity data at 24h (*5 daphnids per replicate)
Daphnids immobilised per replicate* | ||||||
Nominal concentration (mg/L) | replicate A | replicate B | replicate C | replicate D | Total of immobilised daphnids | percentage of immobilisation |
Control |
0 | 0 | 0 | 0 | 0 | 0 |
SL | 1 | 2 | 2 | 3 | 8 | 40 |
SL/2 | 1 | 0 | 2 | 2 | 5 | 25 |
SL/4 | 0 | 0 | 0 | 0 | 0 | 0 |
SL/8 | 0 | 0 | 0 | 1 | 1 | 5 |
SL/16 | 0 | 0 | 0 | 0 | 0 | 0 |
Toxicity data at 48h (*5 daphnids per replicate)
Daphnids immobilised per replicate* | ||||||
Nominal concentration (mg/L) | replicate A | replicate B | replicate C | replicate D | total of immobilised daphnids | percentage of immobilisation |
Control | 0 | 0 | 0 | 0 | 0 | 0 |
SL | 5 | 5 | 5 | 5 | 20 | 100 |
SL/2 | 4 | 3 | 4 | 5 | 16 | 80 |
SL/4 | 2 | 3 | 3 | 2 | 10 | 50 |
SL/8 | 0 | 0 | 0 | 1 | 1 | 5 |
SL/16 | 0 | 0 | 0 | 0 | 0 | 0 |
Statistic and error estimates :
EC50 -48h and confidence limits Probit calculation table :
Test item Geometrical mean (mg/L) | Log(C)=x | % immobilised (P) | EP | Y | w | Nw | Nwx | Nwx2 |
0.377 | -0.4237 | 100 | - | 7.1 | 0.110 | 2.20 | -0.93 | 0.395 |
0.192 | -0.7167 | 80 | 5.84 | 6.0 | 0.439 | 8.78 | -6.29 | 4.510 |
0.088 | -1.0555 | 50 | 5.00 | 4.7 | 0.616 | 12.32 | -13.0 | 13.73 |
0.043 | -1.3665 | 5 | 3.36 | 3.5 | 0.269 | 5.38 | -7.35 | 10.05 |
0.020 | -1.6990 | 0 | - | 2.2 | 0.025 | 0.50 | -0.85 | 1.443 |
m | -0.976 |
s | 0.262 |
EC50 -48h (mg/L) | 0.106 |
SNw | 29.2 |
SNwx | -28.4 |
SNWx2 | 30.1 |
SE approximative | 0.0118 |
Log SE | 0.0485 |
SE | 0.0118 |
Confidence Limit >95% (mg/L) | 0.1175 |
Confidence Limit <95% (mg/L) | 0.0939 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Ecotoxicity test of Lauryl Oxazoline on Daphnia magna fulfils the requirements of OECD test No. 202 to determine EC50-48h = 0.106 mg/L [0.094 - 0.117] 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 Daphnia magna in a 48-hours test.
Method Summary :
Five daphnids were exposed in 50 mL solution of each replicate at fives concentrations up to water solubility limit. Four replicates were performed including control. Number of immobilised daphnids was recorded after 24h and 48h in all replicates.
Lauryl Oxazoline BPL16 -0047.001 Based on measured concentrations EC50 -48h
[Confidence limit 95%]
0.106 mg/L
[0.094 - 0.117] mg/L
EC10 -48h
[Confidence limit 95%]
0.049 mg/L
[0.043 - 0.054] mg/L
ECX-48h: Effective Concentration corresponding to X% of mobility inhibition in the 48 -hours test
Conclusion :
Ecotoxicity test of Lauryl Oxazoline on Daphnia magna fulfils the requirements of OECD test No. 202 to determine EC50-48h = 0.106 mg/L [0.094 - 0.117] mg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.