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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-911-5 | CAS number: 40412-06-4
- 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:
- 13 Oct 2017 - 16 Nov 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2006 (Annex 5 corrected 28 July 2011)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-thienyl)ethyl toluene-p-sulphonate
- EC Number:
- 254-911-5
- EC Name:
- 2-(2-thienyl)ethyl toluene-p-sulphonate
- Cas Number:
- 40412-06-4
- Molecular formula:
- C13H14O3S2
- IUPAC Name:
- 2-(thiophen-2-yl)ethyl 4-methylbenzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical appearance: white to off-white powder
- Test item storage: at room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and all test concentrations
- Sampling method: 2.0 mL, at t=0 h, t=24 h and t=72 h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤ -15°C) until analysis at the analytical laboratory of the Test Facility.
- At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
- Compliance with the quality criteria regarding maintenance of actual concentrations was checked by running a test vessel at an intermediate item concentration but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test solutions were prepared at a nominal loading rate of 100 mg/L by applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in medium. Thereafter, the aqueous Saturated Solution (SS) was collected by filtration through a 0.45 µm membrane filter (RC55, Whatman) and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
- After preparation, volumes of 50 mL were added to each replicate of the respective test concentration. Subsequently, 1 mL of an algal suspension was added to each replicate providing a cell density of 10^4 cells/mL.
- Controls: Test medium without test item or other additives
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source: In-house laboratory culture
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
- Pre-culture: 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
- Stock culture medium: M1, according to the NPR 6505 (Nederlandse Praktijk Richtlijn no. 6505).
- Pre-culture medium and test medium: M2, according to OECD 201.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 0.24 mmol/L (24 mg CaCO3/L)
- Test temperature:
- 22 - 23°C
- pH:
- At t=0 h: 8.0-8.1
At t=72 h: 7.7-8.3 - Nominal and measured concentrations:
- Nominal: Solutions containing 0.32, 1.0, 3.2, 10, 32 and 100% of a Saturated Solution prepared at a loading rate of 100 mg/L.
Measured: 0.024, 0.074, 0.24, 0.71, 2.4, 7.2 mg/L (Time Weighted Average concentrations). Time Weighted Average concentrations were calculated to determine the effect parameters because concentrations were found to decrease with time. See Tables 1 and 2 in 'Any other information on results' for details on measured concentrations and TWA. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass, containing 50 mL of test solution
- Capped vessels were distributed at random in the incubator and daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density (mean): 275 x 10^4 cells/mL
- 3 replicates of each test concentration
- 6 replicates of the control
- 1 extra replicate of each test group for sampling purposes
- 1 or 2 replicates of each test concentration without algae
GROWTH MEDIUM
- Standard medium used: yes, M2 medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2, formulated using Milli-RO water (tapwater purified by reverse osmosis)
- Intervals of water quality measurement: pH: at the beginning and at the end of the test for all test concentrations and the control. Temperature of medium: continuously in a temperature control vessel.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod, light intensity and quality: Continuously using TLD-lamps with a light intensity at 87 μE/m2/s
EFFECT PARAMETERS MEASURED
- Cell density was measured at t= 24, 48, and 72 h.
- Determination of cell concentrations: At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe (pathlength =10 mm). Algal medium was used as blank and the extra replicates, without algae, as background for the treated solutions.
TEST CONCENTRATIONS
- Combined Limit/range finding study test concentrations: Control, 1.0, 10 and 100% of SS prepared at a nominal loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes; expected ErC50 was between 10 and 100% of SS prepared at a nominal loading rate of 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (performed Sep 2017)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidcence interval: 3.1-3.3 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.1 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 0.98-1.2 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.074 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: Based on statistical significance
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.24 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: Based on biological relevance
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: Microscopic observations at the end of the test revealed a normal and healthy appearance of the algal cells exposed to 0.71 mg/L (TWA concentration) when compared to the control.
- Growth rates were in the range of the controls at the two lowest test concentrations during the 72-hour test period, whereas the growth rates of algae exposed to TWA concentrations of 0.24 mg/L and higher were increasingly reduced. Statistically significant inhibition of growth rate was found at test concentrations of 0.24 mg/L and higher. However, the effects observed at 0.24 mg/L were considered not biologically relevant and therefore, the NOErC based on biological relevance was set to 0.24 mg/L.
- All water quality parameters remained within the requirements as laid down in the study plan throughout the test. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- The EC50 for growth rate inhibition (72h-ErC50) was 1.1 mg/L with a 95% confidence interval ranging from 1.1 to 1.1 mg/L. The historical ranges for growth rate inhibition lie between 0.82 and 2.3 mg/L. Hence, the 72h-ErC50 for the algal culture tested corresponds with this range. - Reported statistics and error estimates:
- Statistical significance: Multiple Sequentially-rejective Welsh-t-test After Bonferroni-Holm, α=0.05, one-sided, smaller.
ECx: Weibull analysis using linear max. likelihood regression.
The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany).
Any other information on results incl. tables
Table 1: Final Test: Test Samples
Time of sampling |
Percentage of SS(a) |
Analyzed concentration |
Relative to |
0 |
0 |
n.d. |
|
|
0.32 |
0.031(c) |
|
|
1.0 |
0.0947 |
|
|
3.2 |
0.303 |
|
|
3.2(b) |
0.311 |
|
|
10 |
0.917 |
|
|
32 |
2.94 |
|
|
100 |
9.19 |
|
24 |
0 |
n.d. |
n.a. |
|
0.32 |
0.026(c) |
85 |
|
1.0 |
0.0839 |
89 |
|
3.2 |
0.269 |
89 |
|
3.2(b) |
0.275 |
89 |
|
10 |
0.799 |
87 |
|
32 |
2.59 |
88 |
|
100 |
7.30 |
79 |
72 |
0 |
n.d. |
n.a. |
|
0.32 |
0.017(c) |
55 |
|
1.0 |
0.052(c) |
55 |
|
3.2 |
0.162 |
54 |
|
3.2(b) |
0.218 |
70 |
|
10 |
0.516 |
56 |
|
32 |
1.83 |
62 |
|
100 |
6.08 |
66 |
Samples were stored in the freezer (≤ -15°C) until the day of analysis.
(a) Percentage of a saturated solution (SS) prepared at a loading rate of 100 mg/L.
(b) Without algae.
(c) Estimated value, calculated by extrapolation of the calibration curve.
n.d. Not detected.
n.a. Not applicable.
Table 2: Measured Concentrations Versus Nominal Concentrations
Nominal conc. (mg/L) |
Measured concentration (mg/L) |
TWA (mg/L) |
||
t=0h |
t=24h |
t=72 h |
||
0.32 |
0.031 |
0.026 |
0.017 |
0.024 |
1.0 |
0.0947 |
0.0839 |
0.052 |
0.074 |
3.2 |
0.303 |
0.269 |
0.162 |
0.24 |
3.2# |
0.311 |
0.275 |
0.218 |
0.26 |
10 |
0.917 |
0.799 |
0.516 |
0.71 |
32 |
2.94 |
2.59 |
1.83 |
2.4 |
100 |
9.19 |
7.30 |
6.08 |
7.2 |
# – without algae.
Table 3: Growth Rate And Percentage Inhibition For The Total Test
Period
TWA conc. (mg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.872 |
0.0103 |
6 |
|
0.024 |
1.875 |
0.0029 |
3 |
-0.1 |
0.074 |
1.874 |
0.0072 |
3 |
-0.1 |
0.24 |
1.788 |
0.0016 |
3 |
4.5# |
0.71 |
1.527 |
0.0274 |
3 |
18.4* |
2.4 |
1.320 |
0.0109 |
3 |
29.5* |
7.2 |
0.014 |
0.0247 |
3 |
99.2* |
* - effect was statistically significant
#- effect was statistically significant but biologically not relevant (<10%).
Table 4: Growth Rate And Percentage Inhibition At Different Time
Intervals
TWA conc. (mg/L) |
n |
0 – 24 h |
24 – 48 h |
48 – 72h |
|||
Mean |
%Inhibition |
Mean |
%Inhibition |
Mean |
%Inhibition |
||
Control |
6 |
2.084 |
0.0 |
1.982 |
0.0 |
1.551 |
0.0 |
0.024 |
3 |
2.071 |
0.6 |
1.987 |
-0.2 |
1.566 |
-1.0 |
0.074 |
3 |
2.053 |
1.5 |
2.011 |
-1.5 |
1.557 |
-0.4 |
0.24 |
3 |
2.187 |
-5.0 |
1.666 |
16.0 |
1.512 |
2.5 |
0.71 |
3 |
1.913 |
8.2 |
1.500 |
24.3 |
1.168 |
24.7 |
2.4 |
3 |
1.680 |
19.4 |
1.216 |
38.7 |
1.065 |
31.3 |
7.2 |
3 |
0.000 |
100.0 |
0.357 |
82.0 |
-0.315 |
120.3 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria
- Conclusions:
- The 72-h ErC50, ErC10 and NOErC for Pseudokirchneriella subcapitata was respectively 3.2 mg/L, 1.1 mg/L and 0.24 mg/L (based on biological relevance), based on nominal concentrations.
- Executive summary:
In a 72 h toxicity study conducted according to OECD guideline 201 and GLP principles, freshwater algae (Pseudokirchneriella subcapitata) were exposed to the test item at 0.32, 1.0, 3.2, 10, 32 and 100% of a Saturated Solution prepared at a nominal loading rate of 100 mg/L (3 replicates) and an untreated control (6 replicates). Measured concentrations at the end of the exposure period had decreased to 54 -70% of the initial measured concentrations, therefore the Time Weighted Average exposure concentrations were used to determine the effect parameters. At the end of the test, a dose-related increase of inhibition of growth rate was observed up to 99% inhibition at the highest test concentration.The EC50 for growth rate inhibition (72h-ErC50) was 3.2 mg/L, the 72h-ErC10 was 1.1 mg/L. The 72h-NOErC was 0.24 mg/L and 0.074 mg/L based on biological relevance and statistical significance, respectively. The study met all validity criteria, and is considered reliable without restriction.
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.