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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 434-600-2 | CAS number: 2628-16-2
- 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:
- 2018-01-15 to 2018-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 434-600-2
- EC Name:
- -
- Cas Number:
- 2628-16-2
- Molecular formula:
- CH3CO2C6H4CH=CH2
- IUPAC Name:
- 4-ethenylphenyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity analysed 98.4 % w/w
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - analytical samples of all test item concentrations and control were taken at test start (0 hours fresh), at 24 hours (aged), 48 hours (aged) and at test end (72 hours aged).
- three replicates per treatment group containing algae were set up for the analytical sampling
- Storage before analysis: All samples were stored deep frozen until they were transferred to the analytical laboratory.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- AAP-Medium (according to Annex 3 of OECD 201)
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: Hindak
- Source (laboratory, culture collection):
- Age of inoculum (at test initiation): purchased from a commercial supplier MBM Sciencebridge GmbH, Hans-Adolf-Krebs-Weg 1, D-37077 Göttingen, Germany.
- Method of cultivation: The algae are grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state.
- culture conditions are as follows:
-- illumination: continuously (approx. 4440 - 8880 lux at cell culture level or 60 - 120 μEm-2s-1)
-- temperature: 21 - 24 °C
-- culture flasks: 100 mL Erlenmeyer flasks
-- CO2 supply by shaking on a rotating shaker, approximately 105 rpm
ACCLIMATION
3 to 4 days before start of the test, test medium was inoculated with the test organism and held under test conditions in order to produce a pre-culture in the state of exponential growth.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Remarks:
- synthetic growth medium
- Limit test:
- no
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- At 24, 48 and 72 hours from the test initiation, the number of cells in each replicate was determined
- Post exposure observation period:
- not applicable
Test conditions
- Hardness:
- not specified
- Test temperature:
- 22.2 – 23.3 °C
- pH:
- 7.59 – 9.18 (control)
- Dissolved oxygen:
- not specified
- Salinity:
- not specified
- Conductivity:
- not specified
- Nominal and measured concentrations:
- 0.5 x 10e4 cells/mL (targeted initial cell density)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: serum bottles with crimp caps
- Type : closed with crimp caps
- Material, size, headspace, fill volume: 120 mL, minimal headspace above test solution to reduce volatilisation due to he high vapour pressure of the substance.
- Aeration: agitator added to each serum bottle
- CO2 supply: NaHCO3 was added
- Renewal rate of test solution (frequency/flow rate): no renewal, static test. dens
- Initial cells density: 0.5 × 10^4 cells/mL.
- Average control end cells density: 68.77 × 10^4 cells/mL.
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, AAP medium
- Detailed composition if non-standard medium was used: according to Annex 3 of OECD 201
OTHER TEST CONDITIONS
- Sterile test conditions: yes/n
- Adjustment of pH: to pH 7.5
- Photoperiod: Continuously
- Light intensity and quality: 88.8 μEm-2s-1 (mean)
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: fluorescence detection every 24h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 4, a larger spacing factor was selected due to the flat dose response curve in the non-GLP range finding study
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: GLP range-finding test with nominal test item concentrations of 100,10.0, 1.00, 0.100, 0.0100 mg/L and control, was used to decide upon the test concentrations
- Test concentrations: 100, 25.0, 6.25, 1.56, 0.391 mg/L and control - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate is tested in a separate study twice a year at the test facility
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.715 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.45 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.36 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.246 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.463 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Unusual cell shape: no
- Flocculation: only singular cells - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 0.703 mg/L - Reported statistics and error estimates:
- The statistical evaluation for the 72 hours period was performed for growth rate and yield using SAS® (2002–2010).
A test for normality of the data was performed by calculating the Shapiro-Wilk statistic and the homogeneity of variance of the data was evaluated by calculating the Levene Test. The NOEC and LOEC were determined by using a multiple comparison method (Dunnetts-ttest, left sided, for growth rate and yield). The EC10, 20, 50-values for were determined by probit analysis following the normal (growth rate nominal and actual; yield actual) and logistic (yield nominal) distribution, respectively. Due to statistical reasons inhibition-values above 100 % were set to 100 and values below 0 % were set to zero. Only concentrations within a clear concentration response relation were used for calculations.
Any other information on results incl. tables
Biological results:
Average cell numbers:
Conc. | Average cell numbers [104/mL] | |||
[mg/L] | 0 h | 24 h | 48 h | 72 h |
Control | 0.6 | 2.39 | 16.55 | 68.77 |
0.391 | 0.6 | 2.36 | 15.68 | 68.81 |
1.56 | 0.6 | 2.31 | 17.03 | 72.69 |
6.25 | 0.6 | 2.17 | 13.11 | 52.7 |
25 | 0.6 | 1.59 | 2.92 | 4.45 |
100 | 0.6 | 0.72 | 0.56 | 0.41 |
Percentage inhibition of growth rate and yield:
Conc. | % Inhibition of growth rate | % Inhibition of yield |
[mg/L] | 0 h – 72 h | 0 h – 72 h |
Control | 0 | 0 |
0.391 | 0.2 | -0.1 |
1.56 | -1 | -5.8 |
6.25 | 5.8 | 23.6 |
25 | 57.9 | 94.4 |
100 | 108 | 100.3 |
Analytical results:
Test item, nominal concentration (mg/L) | sampling | measured concentration (mg/L) | % of nominal | geometric mean (mg/L) |
Control | 0h fresh | < LOQ | - | - |
24h aged | < LOQ | - | ||
48h aged | < LOQ | - | ||
72h aged | < LOQ | - | ||
0.391 | 0h fresh | 0.422 | 108 | 0,117 |
24h aged | 0,176 | 45 | ||
48h aged | < LOQ | - | ||
72h aged | < LOQ | - | ||
1.56 | 0h fresh | 1.5 | 96,2 | 0.246 |
24h aged | 0.974 | 62.4 | ||
48h aged | < LOQ | - | ||
72h aged | < LOQ | - | ||
6.25 | 0h fresh | 6.11 | 97.8 | 0.463 |
24h aged | 3 | 48 | ||
48h aged | < LOQ | - | ||
72h aged | < LOQ | - | ||
25 | 0h fresh | 20.8 | 83.2 | 3.05 |
24h aged | 23.7 | 94.8 | ||
48h aged | 3.47 | 13.9 | ||
72h aged | < LOQ | - | ||
100 | 0h fresh | 101 | 101 | 44.1 |
24h aged | 92.3 | 92.3 | ||
48h aged | 76.3 | 76.3 | ||
72h aged | 5.31 | 5.31 |
Toxicological endpoints for the test item:
|
Test item[mg/L] |
|
nominal |
actual /95 % confidence limits |
|
ErC10(Growth rate)1) |
8.37 |
0.715 |
95 % confidential limits |
6.48 - 10.1 |
0.525 – 0.906 |
ErC201) |
11.4 |
1.09 |
95 % confidential limits |
9.27 - 13.4 |
0.855 – 1.34 |
ErC501) |
20.4 |
2.45 |
95 % confidential limits |
17.6 - 23.6 |
2.01 – 3.07 |
EyC10(Yield)2) |
4.53 |
0.3601) |
95 % confidential limits |
3.62 - 5.35 |
0.0792 – 0.654 |
EyC202) |
5.93 |
0.4931) |
95 % confidential limits |
4.98 - 6.84 |
0.167 – 0.932 |
EyC502) |
9.40 |
0.9001) |
95 % confidential limits |
8.20 - 10.9 |
0.477 – 2.67 |
NOEC3) |
1.56 |
0.246 |
LOEC3) |
6.25 |
0.463 |
1)Probit analysis following normal distribution
2)Probit analysis following logistic distribution
3)Following Dunnetts-t-test (left-sided, p<0.05) for growth rate and for yield
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Significant inhibitory effects were determined for growth rate and yield at test item concentrations of 6.25 mg/L (nominal) and 0.463 mg/L (actual) and above. The EC50 values for growth rate and yield inhibition were found to be 2.45 mg/L and 0.9 mg/L respectively (measured, geometric mean). The EC10 values for growth rate and yield inhibition were found to be 0.715 mg/L and 0.360 mg/L respectively (measured, geometric mean).
- Executive summary:
The objective of this study was to determine the inhibitory effects of the test item on the growth of the single cell green alga Pseudokirchneriella subcapitata. The study has been performed according to OECD TG 201 and in compliance to GLP.
Based on the results of a GLP range-finding test with nominal test item concentrations of 100, 10.0, 1.00, 0.100, 0.0100 mg/L and control, the following nominal test item concentrations were tested in the main test (spaced by a factor of 4.0): 100, 25.0, 6.25, 1.56, 0.391 mg/L and control. Six replicates were employed for the control and three for each test item concentration. Three additional replicates per treatment group containing algae were set up for the analytical sampling.
Analytical samples were taken and analysed in the main test from control and all test item concentrations at 0 hours (initial value) from fresh test solutions and after 24 hours, 48 hours and 72 hours from aged test solutions. Since the test concentration decreased over time, the effect concentrations have been expressed as measured, geometric mean values.
All test validity criteria were fulfilled.
Significant inhibitory effects were determined for growth rate and yield at test item concentrations of 6.25 mg/L (nominal) and 0.463 mg/L (measured, geometric mean) and above. The overall LOEC was therefore determined to be 6.25 mg/L (nominal) and 0.463 mg/L (measured, geometric mean), the corresponding NOEC was set at 1.56 mg/L (nominal) and 0.246 mg/L(measured, geometric mean).
The EC10-value for growth rate (ErC10) was determined to be 8.37 mg/L (nominal) and 0.715 mg/L
The objective of this study was to determine the inhibitory effects of the test item on the growth of the single cell green alga Pseudokirchneriella subcapitata. The study has been performed according to OECD TG 201 and in compliance to GLP.
Based on the results of a GLP range-finding test with nominal test item concentrations of 100, 10.0, 1.00, 0.100, 0.0100 mg/L and control, the following nominal test item concentrations were tested in the main test (spaced by a factor of 4.0): 100, 25.0, 6.25, 1.56, 0.391 mg/L and control. Six replicates were employed for the control and three for each test item concentration. Three additional replicates per treatment group containing algae were set up for the analytical sampling.
Analytical samples were taken and analysed in the main test from control and all test item concentrations at 0 hours (initial value) from fresh test solutions and after 24 hours, 48 hours and 72 hours from aged test solutions. Since the test concentration decreased over time, the effect concentrations have been expressed as measured, geometric mean values.
All test validity criteria were fulfilled.
Significant inhibitory effects were determined for growth rate and yield at test item concentrations of 6.25 mg/L (nominal) and 0.463 mg/L (measured, geometric mean) and above. The overall LOEC was therefore determined to be 6.25 mg/L (nominal) and 0.463 mg/L
(measured, geometric mean), the corresponding NOEC was set at 1.56 mg/L (nominal) and 0.246 mg/L
(measured, geometric mean)
The EC10-value for growth rate (ErC10) was determined to be 8.37 mg/L (nominal) and 0.715 mg/L (measured, geometric mean). The EC10-value for yield (EyC10) was 4.53 mg/L (nominal) and 0.360 mg/L (measured geometric mean).
The EC50-value for growth rate (ErC50) was determined to be 20.4 mg/L (nominal) and 2.45 mg/L (measured, geometric mean). The EC50-value for yield (EyC50) was 9.40 mg/L (nominal) and 0.900 mg/L (measured, geometric mean).
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.