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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 948-910-5 | CAS number: -
- 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:
- 06 May 2019 - 26 June 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- adopted March 23, 2006, corrected July 28, 2011
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- August 24, 2009
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aqueous-phase Aquatic Toxicity Testing of Difficult Test Chemicals"
- Version / remarks:
- February 08, 2019
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A; Section 4) and Annex III (part A; Section 5) of directive 91/414
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Essential oil of Tanacetum annuum
- IUPAC Name:
- Essential oil of Tanacetum annuum
- Test material form:
- liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- TOC analysis
- Details on sampling:
- Sampling:
The samples were taken from the biological phase of the study. Collecting, storage and handing over of the samples were the Study Director’s responsibility. The information concerning the samples was provided by the Study Director. Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the start of the test. For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the control were collected at the end of the test (after 72 hours) by pouring together the contents of the test beakers of each treatment. The samples remained undiluted until analysis.
Storage:
All samples were stored in a fridge (4°C ± 4°C), protected from light until analysis was performed. Afterwards the samples were again stored cooled (4°C ± 4°C) and will be kept stored up to the date of the final report.
Analyses:
The dissolved fraction of the test item Blue Tansy oil was analysed in the duplicate test media samples from all test concentrations and the control samples from both sampling times (0 and 72 hours).
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Dosage of Test Item:
The test item is not well soluble in test medium. To avoid physical effects of undissolved test item on algae, no concentrations above the solubility limit of the test item in test water was tested. Therefore, defined amounts of the test item were added directly to the test water for the five higher test concentration and were carefully stirred for approximately 24 hours in the dark to dissolve as much of the test item as possible.
The highest loading rate of 100 mg test item/L was prepared by mixing 200.8 mg test item into 2008 mL test water, for the loading rate of 32 mg test item/L, 63.7 mg test item were mixed into 1991 mL test water, for the concentration of 10 mg test item/L, 19.9 mg were mixed into 1990 mL test water. The loading rate of 3.2 mg test item/L was prepared by mixing 16.3 mg into 5094 mL test water and for 1.0 mg test item/L, 10.5 mg were mixed into 10500 mL test water. Adequate volumes of the water accommodated fraction of 1.0 mg test item/L were used to prepare the desired loading rates of 0.32 and 0.1 mg/L. After mixing followed a period of 20 minutes of settling to allow phase separation. At the two highest loading rates of 100 and 32 mg/L emulsion drops stayed in the water phase. These loading rates were therefore filtered with a folded filter. The test media of all lower loading rates could be withdrawn from a tap, which was located approx. 2 cm above the bottom after first flushing the tap. These accommodated fractions were used as test media for the test. The test media were prepared just before introduction of the algae (= start of the test).
Control:
In the control, test water was used without addition of the test item.
Appearance of the Test Item in Test Medium:
There were no remarkable observations
Other relevant information:
Phase separation in water was not possible in the loading rates of 100 and 32 mg test item/L. Emulsion drops were still in the water phase. Therefore unsolved test item was separated by a folded filter. There are however no presumed effect on the study. The TOC content of the concentrations was comparable to the pre-test, where the separation from the water phase was possible. The colour of the test medium of the concentrations did not change after filtration.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Species: Pseudokirchneriella subcapitata (KORSHIKOV)
- Strain: No. 61.81 SAG, formerly known as Selenastrum capricornutum, and recently renamed as Raphidocelis subcapitata (KORSHIKOV)
- Origin: The algae were supplied by the "Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen", 37073 Göttingen, Germany.
- Breeding Conditions: The algae were cultivated in the laboratories of ibacon under standardised conditions according to the test guidelines
ACCLIMATION
- Acclimation period: Algae cells were taken from an exponentially growing pre-culture 4 days prior
- Culturing media and conditions (same as test or not): pre-culture medium and test medium are the same
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg/L as CaCO3
- Test temperature:
- 21.8 to 23.0 °C
- pH:
- Test item treatments at test start: 8.3 to 8.4
Test item treatments at test end: 8.6 to 9.7
Control start: 8.2
Control test end: 9.6 - Nominal and measured concentrations:
- Water accommodated Fractions (WAF) nominal loading rates: Control, 0.1, 0.32, 1.0, 3.2, 10, 32 and 100 mg/L
Measured TOC corrected by the mean value of the control (n=2)
t=0 hr : n.a,t=72 hr: n.a,
Mean value of all measured samples per treatment group. The results were corrected by the mean value of the control (n=2). - Details on test conditions:
- TEST CONDITIONS:
- Type and Size: Erlenmeyer flasks of 50 mL volume with approximately 50 mL of test medium
- Control end cells density: 77.853 [10000/mL]
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Light Regime: Continuous illumination
- Light Intensity: The light intensity was measured once during the test at 6 positions distributed over the experimental area at the surface of the test media.
Mean light intensity: 5093 lux (range: 4570 to 5430 lux)
GROWTH MEDIUM
- Standard medium used: yes - OECD Medium
TEST MEDIUM / WATER PARAMETERS
- Water Temperature: The temperature was measured daily in an Erlenmeyer flask filled with water and incubated under the same conditions as the test flasks.
- pH-Values: The pH was measured in all test item concentrations and the control at the start and the end of the test.
- Recording: Test conditions were recorded with suitable instruments and documented in the raw data.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The cell density on each observation time was determined by spectrophotometric measurement. Therefore, defined volumes of the algal suspensions from all replicates and from the blanks were sampled after 24, 48 and 72 hours of exposure, and were not replaced. The algal cell densities were calculated by subtracting the absorption of the blanks, from each of the measured absorption of the test media (with algae). Based on the counted cell densities and the absorption from an algal suspension and its dilutions, a linear regression was performed for the calculation of the cell densities of the replicates during the test.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study: Non-GLP pre-experiments were performed to determine a suitable concentration range and to establish suitable methods to prepare the test solutions.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 20.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % conf. interval 17.0 - 24.9 mg test item/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 3.63 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % conf. interval 2.43 - 5.42 mg test item/L
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 3.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95 % conf. interval 2.94 - 3.51 mg test item/L
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 0.338 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95 % conf. interval 0.281 - 0.406 mg test item/L
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities: no
The microscopic examination of the shape of the algal cells after 72 hours of test duration did not show any difference between the algae that had been growing up to a nominal test concentration of 100 mg test item/L and the algal cells in the control. Thus, the shape of the algal cells was not obviously affected up to this test concentration, the highest loading rate tested.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No remarkable observations, clear test medium
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes * Historical ranges not included
- 72h-ErC50: 0.941 mg/L (95% C.I. 0.910-0.973 mg/L) - Reported statistics and error estimates:
- Based on the calculated cell densities, the 72 hour ErL50 and the 72 hour EyL50, the corresponding EL20 and EL10 values and where possible their 95 %-confidence limits were calculated by Probit analysis. For the determination of the 72 hour LOEL and the 72 hour NOEL, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values by Williams t-test (yield and growth rate).
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
Any other information on results incl. tables
Analytical Results:
The quantification of the test item Blue Tansy Oil in the test samples was performed using total organic carbon (TOC) measurement. The TOC content of the test item was determined in the test media samples from all loadings rates at test start and test end. The highest WAF loading rate 100 mg test item/L was found to contain approximately 15 mg carbon/L. The carbon content of the lowest WAF loading rate of 0.1 mg test item/L was found to be below the Limit of Quantification of 2.5 mg carbon/L. The analytical results show that the WAFs were prepared correctly because of the dose dependent increase of TOC with increasing loading rate. Further the stability of the exposure based on TOC during the test (e.g. no volatilisation) can be concluded from the highest two loading rates.
Yield y and Percentage Inhibition of y during the Test Period
Nominal Loading Rate [mg test item/L] |
Yields y [10000 cells/ml] and % inhibition of y |
|||||
0-24 hours |
0-48 hours |
0-72 hours |
||||
y |
% |
y |
% |
y |
% |
|
Control |
2.203 |
- |
16.392 |
- |
77.353 |
- |
0.1 |
2.163 |
1.9 |
15.531 |
5.3 |
72.605 |
6.1 |
0.32 |
1.918 |
13.0 |
14.044 |
14.3* |
67.566 |
12.7* |
1.0 |
2.244 |
-1.9 |
11.618 |
29.1* |
57.706 |
25.4* |
3.2 |
1.591 |
27.8 |
8.253 |
49.7* |
41.493 |
46.4* |
10 |
1.020 |
53.7* |
5.123 |
68.7* |
20.898 |
73.0* |
32 |
0.449 |
79.6* |
1.289 |
92.1* |
3.370 |
95.6* |
100 |
0.000 |
100.0* |
0.650 |
96.0* |
0.518 |
99.3* |
negative values in ‘% inhibition’ indicate an increase in growth relative to that of the control
* mean value significantly different from the control(tested with Bonferroni-Welch t-test (24h) and Williams t-test (48 and 72h),a = 0.05, one-sided smaller)
Growth Rates μ and Percentage Inhibition of μ during the Test Period
Nominal Loading Rate [mg test item/L] |
Growth rates µ [1/day] and % inhibition of µ |
|||||
0-24 hours |
0-48 hours |
0-72 hours |
||||
µ |
% |
µ |
% |
µ |
% |
|
Control |
1.686 |
- |
1.758 |
- |
1.682 |
- |
0.1 |
1.670 |
1.0 |
1.733 |
1.4 |
1.662 |
1.2 |
0.32 |
1.573 |
6.7 |
1.684 |
4.2 |
1.637 |
2.7 |
1.0 |
1.677 |
0.5 |
1.591 |
9.5 |
1.585 |
5.7 |
3.2 |
1.425 |
15.5* |
1.430 |
18.7* |
1.477 |
12.2* |
10 |
1.109 |
34.2* |
1.208 |
31.3* |
1.251 |
25.6* |
32 |
0.641 |
62.0* |
0.589 |
66.5* |
0.607 |
63.9* |
100 |
0.000 |
100.0* |
0.343 |
80.5* |
0.186 |
89.0* |
* mean value significantly different from the control(tested with Williams t-test (24, 48 and 72h),a = 0.05, one-sided smaller)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- In controls: cell density increased by an average factor of >16 within 72 hours, mean CV for section-by-section specific growth rates did not exceed 35% and CV of average specific growth rates during the whole test period did not exceed 7%
- Conclusions:
- The ErL50, ErL10 and NOELR were 20.6, 3.63 and 1.0 mg test item /L respectively.
- Executive summary:
Algae toxicity was assessed in an OECDTG 201 static concentration-response test study with closed vessel design. Six exponentially growing algal cultures were exposed for 72h to an untreated control, whereas three replicates per group were exposed to WAFs prepared at loading rates of 0.1, 0.32, 1.0, 3.2, 10, 32 and 100 mg Blue Tansy Oil per litre. The total exposure period was 72 hours and samples for Total Organic Carbon (TOC) analysis were taken at the start and at the end of exposure.WAFs were considered properly prepared, based on a dose dependent increase of TOC concentrations with loading rate. Exposure concentrations were considered stable over the test period based on TOC analyses concluded from the two highest loading rates. Therefore all reported results refer to nominal values.The 72-hour ErL50, ErL10 and NOELR were determined as 20.6, 3.63 and 1.0 mg test item /L respectively. The 72-hour EyL50 was calculated to be 3.22 mg test item/L, the EyL10 as 0.338 mg test item/L, and the 72-hour NOEyL was determined to be 0.1 mg test item/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.