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EC number: 229-861-2 | CAS number: 6790-58-5
- 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
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 October 2008 to 10 December 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was performed according to OECD Guideline 201 (2006) and the EC Method C.3 with GLP certificate. The test method was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000. All validity criteria were fulfilled.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- No. 440/2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OECD GLP (inspected from 05th to 09th and 26th to 30th November 2007 / signed on 12th November 2008)
- Specific details on test material used for the study:
- solubility in water = 1.88 mg/L
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: For measurement of the actual concentrations of the test item, duplicate samples were taken from the test media of all test concentrations at the start of the test (without algae) and at the end of the test (containing algae). At the same sampling times, duplicate samples were also taken from the control. For the 72-hour stability samples, additional flasks containing the test medium with algae were incubated for each treatment under the test conditions. This was necessary as the volume of test solution of the treatment replicates (3 x 15 mL) was too small to perform the analyses. A volume of 200-500 mL per sample was necessary for analytical purposes. All samples were stored deep-frozen (at about -20 °C) immediately after sampling. Based on a pre-experiment the test item was shown to be stable under the storage conditions. The concentrations of the test item were determined in the duplicate test medium samples from the undiluted filtrate. The samples from the dilutions of 1:22, 1:10, 1.4.6 and 1:2.2 were not analysed, since these concentrations were below the NOEC determined in this test. From the control samples, one of the duplicate samples was analysed from the corresponding sampling times.
- Sample storage conditions before analysis: The samples were stored deep-frozen and protected from light until analysis was performed. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to the low water solubility of the test item, a dispersion with the loading rate of 100 mg/L was prepared by dispersing 140 mg of the test item in 1400 mL of test water using ultrasonic treatment for 15 minutes. Then, the dispersion was stirred by a magnetic stirrer at room temperature in the dark over 96 hours to dissolve a maximum amount of the test item in the dispersion. The long stirring period of 96 hours was selected according to the results of a pre-experiment (non-GLP) which showed that the maximum concentration of test item was reached after the
stirring period of 96 hours. Furthermore it was shown within this pre-experiment that the test item was stable in water during a period of 96 hours. After the 96-hour stirring period, the dispersion was filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size 0.45 μm). The undiluted filtrate was used as the highest concentrated test medium and as stock solution for the preparation of the test media of lower test concentrations. For the preparation of the test media of the lower test concentrations, the filtrate was diluted with test water. The test media were prepared just before the start of the test (= addition of algae).
- Eluate: test water
- Differential loading: 1:22, 1:10, 1:4.6, 1:2.2 and the undiluted filtrate
- Controls: yes (test water without test item)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): yes in the loading rate of 100 mg/L only. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Selenastrum capricornutum
- Strain: No. 61.81 SAG
- Source (laboratory, culture collection): supplied by the Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, Göttingen/Germany).
- Age of inoculum (at test initiation): no data
- Method of cultivation: The algae were cultivated at Harlan Laboratories under standardized conditions according the test guidelines.
ACCLIMATION
no data - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- None
- Post exposure observation period:
- None
- Hardness:
- The water harness (calculated) of the test water was 0.24 mmol/L ( = 24 mg/L as CaCO3).
- Test temperature:
- The test flasks were incubated in a temperature-controlled water bath at a temperature of 22-23°C.
- pH:
- See table 2 in "Any other information on results incl. tables"
- Dissolved oxygen:
- No data
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: 1:22, 1:10, 1:4.6, 1:2.2 and the undiluted filtrate (loading rate of 100 mg/L)
Measured concentrations: At the start of the test, the analytically determined concentration of the test item in the undiluted filtrate was 1.7 mg/L. At the end of the test, 1.2 mg/L were found. The mean measured concentration (calculated as geometric mean) was of 1.4 mg/L in the undiluted filtrate. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type (delete if not applicable): covered with a glass dish
- Material, size, headspace, fill volume: 50 mL Erlenmeyer flasks
- Aeration: During the test, the test solutions were continuously stirred by magnetic stirrers.
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- Initial cells density: 10000 cells/mL, corresponding to 0.897 x 10^3 relative fluorescence units.
- Control end cells density: 57.4 x 10^3 relative fluorescence units.
- No. of organisms per vessel: not applicable
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): not applicable
GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used: not applicable
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water was prepared according to the test guidelines. Analytical grade salts were dissolved in sterile purified water. See table 1 in "Any other information on materials and methods incl. tables".
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no data
- Photoperiod: no data
- Light intensity and quality: The test flasks were illuminated by fluorescent tubes (Philips TLD 36 W/840), installed above the test flasks. The mean measured light intensity at the level of the test solutions was approximately 7400 Lux (range: 6200 to 8400 Lux, measured at nine places in the experimental area).
- Salinity (for marine algae): not applicable
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter (Coulter Counter, Model ZM).
- Chlorophyll measurement: no
- Other: A small volume of the algal suspension was daily withdrawn from each test flask for the measurement of the biomass, and was not replaced. The algal biomass in the samples was determined by fluorescence measurement (BIO-TEK Multi-Detection Microplate Reader, Model FLx800). The measurements were performed in duplicate. At the end of the test, a sample was taken from the control and from the test medium with the loading rate of 100 mg/L. The shape and size of the algal cells were visually inspected.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: dilution factors (1:22, 1:10, 1:4.6, 1:2.2 and the undiluted filtrate)
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: yes (non-GLP)
- Results used to determine the conditions for the definitive study: no data - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- corresponding to a loading rate of 100 mg/L
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Remarks on result:
- other: No effect up to the attainable limit of solubility in test medium.
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- corresponding to a loading rate of 100 mg/L
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Remarks on result:
- other: No effect up to the attainable limit of solubility in test medium.
- Details on results:
- The 72-hour EC10 and EC50 values of the test item could not be determined because of the absence of a significant inhibitory effect of the test item on the algal growth at the tested concentrations. For the determination of the NOEC, average growth rate and yield at the test concentrations were compared to the control values by Dunnett’s tests.
- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no abnormalities were observed.
- Unusual cell shape: no data
- Colour differences: no
- Flocculation: no
- Adherence to test vessels: no
- Aggregation of algal cells: no
- Other: The microscopic examination of the algal cells at the end of the test showed no difference between the algae growing at the test medium with a loading rate of 100 mg/L and the algal cells in the control. The shape and size of the algal cells were obviously not affected by the test item up to at least this concentration.
- Any stimulation of growth found in any treatment: no stimulation of growth
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: none - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: The result of the latest positive control test performed in 2008 showed that the sensitivity of the test system was within the internal historical range (72-h EC50 for the growth rate: 1.20 mg/L (Study B83755), range of the 72-h EC50 for the growth rate from 2000 to 2008: 0.71-1.74 mg/L).
- Other: none - Reported statistics and error estimates:
- None
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item had no significant inhibitory effect on the growth of the algae (average growth rate and yield) during the test period of 72 hours up to and including the loading rate of 100 mg/L (corresponding on mean measured concentration of 1.4 mg/L). The 72-h NOEC was >= 1.4 mg/L and the 72-h EC50 was > 1.4 mg/L.
- Executive summary:
This study, according to OECD Guideline 201 (2006) and the Commission Regulation (EC) No 440/2008 C.3 with GLP statement, was investigated to evaluate the influence of the test item on the growth of the freshwater green algae species Pseudokirchneriella subcapitata in a 72 -hour static test.
Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was continuously stirred at room temperature in the dark over 96 hours. Then, the dispersion was filtered through a 0.45 µm membrane filter. The undiluted filtrate of the dispersion was used as highest test concentration and as stock solution for the preparation of the lower test concentrations. The following treatments were tested: Dilution 1:22, 1:10, 1:4.6, 1:2.2 and the undiluted filtrate in parallel to a control. The test method was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
Only the highest test concentration was analytically measured since it was determined as the NOEC in this test. At the start of the test, the analytically determined concentration of the test item in the undiluted filtrate was 1.7 mg/L. At the end of the test, 1.2 mg/L were found. The mean measured concentration (calculated as geometric mean) was of 1.4 mg/L. The biological effects are related to the loading of 100 mg/L and to the mean measured concentration of 1.4 mg/L.
The test item had no significant inhibitory effect on the growth of the algae (average growth rate and yield) during the test period of 72 hours up to and including the loading rate of 100 mg/L. The loading rate of 100 mg/L (mean measured concentration of 1.4 mg/L) was therefore determined to be the 72 -hour NOEC. This value might even be higher, but loading rates of the test item exceeding 100 mg/L were not tested, in accordance with the test guidelines. The 72 -hour EC50 was higher than the loading rate of 100 mg/L (mean measured concentration of 1.4 mg/L).
Reference
Table 6.1.5/2: pH values in the treatments
Treatment/ Dilution |
pH values |
|
Start |
End |
|
Control 1 :22 1 :10 1 :4.6 1 :2.2 Undiluted Filtrate |
8.0 8.2 8.2 8.1 8.1 8.0 |
8.6 8.4 8.4 8.5 8.4 8.2 |
Table 6.1.5/3: Biomass of Algae
Treatment / Dilution |
Rep. No. |
Biomass of algae* (relative fluorescence units) |
||
24 h |
48 h |
72 h |
||
Control |
1 2 3 4 5 6 |
3.3 4.9 4.3 4.6 4.7 4.9 |
20.6 25.5 17.9 21.7 25.3 22.9 |
54.3 62.9 58.9 58.7 54.9 54.5 |
Mean SD |
4.4 0.6 |
22.3 2.9 |
57.4 3.5 |
|
1:22 |
1 2 3 |
4.7 4.9 5.0 |
23.5 22.2 19.2 |
94.3 78.9 76.6 |
Mean SD |
4.9 0.1 |
21.6 2.2 |
83.3 9.6 |
|
1:10 |
1 2 3 |
3.8 4.6 4.2 |
19.5 19.4 17.2 |
82.7 79.1 94.7 |
Mean SD |
4.2 0.4 |
18.7 1.3 |
85.5 8.2 |
|
1:4.6 |
1 2 3 |
3.7 5.0 4.6 |
18.2 20.8 19.3 |
79.5 101.0 97.4 |
Mean SD |
4.4 0.7 |
19.4 1.3 |
92.6 11.5 |
|
1:2.2 |
1 2 3 |
4.1 4.3 3.9 |
20.9 22.0 16.3 |
97.1 101.1 86.5 |
Mean SD |
4.1 0.2 |
19.7 3.0 |
94.9 7.6 |
|
Undiluted filtrate (loading rate: 100 mg/L) |
1 2 3 |
4.4 3.9 4.5 |
24.9 23.4 24.2 |
68.3 54.1 67.3 |
Mean SD |
4.2 0.3 |
24.1 0.8 |
63.3 7.9 |
SD: Standard Deviation
*: The biomass was determined by fluorescence measurement (at least duplicate measurements per replicate) and is given as relative fluorescence units (x 10^3). At the start of the test, the initial cell density was 10000 algal cells/mL, corresponding to 0.897 x 10^3 relative fluorescence units.
Table 6.1.5/4: Section-by-Section Growth Rates
Treatment / Dilution |
Section by section growth rates (day-1) and inhibition of the growth rates (Ir) |
|||||
0-24 h |
24-48 h |
48-72 h |
||||
µ |
Ir(%) |
µ |
Ir(%) |
µ |
Ir(%) |
|
Control 1:22 1:10 1:4.6 1:2.2 Undiluted Filtrate |
1.59 1.69 1.54 1.59 1.53 1.55 |
0.0 -6.3 3.2 0.2 4.2 2.4 |
1.62 1.49 1.50 1.49 1.56 1.74 |
0.0 7.8 7.4 8.0 3.6 -7.7 |
0.95 1.35 1.52 1.56 1.58 0.96 |
0.0 -41.7 -59.8 -64.0 -66.0 -0.9 |
Description of key information
Read Across, EU Method C.3, OECD Guideline 201, GLP, key study, validity 2:
No effect up to the attainable limit of solubility in test medium.
72h-EC50 > 1.4 mg/L; 72h-NOEC ≥ 1.4 mg/L., corresponding to a loading rate of 100 mg/L.
Key value for chemical safety assessment
Additional information
To assess the toxicity of the registered substance, (-)-(3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1 -b]furan, to aquatic algae, one key study is available.
This study (Harlan, 2009) was performed on a source substance (which is the racemic form of the registered substance), (±)-(3aR*,5aS*,9aS*,9bR*)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan, according to OECD Guideline 201 and EU Method C.3 with GLP statement, to evaluate the influence of the test item on the growth of the freshwater green algae species Pseudokirchneriella subcapitata in a 72 -hour static test.
Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was continuously stirred at room temperature in the dark over 96 hours. Then, the dispersion was filtered through a 0.45 µm membrane filter. The undiluted filtrate of the dispersion was used as highest test concentration and as stock solution for the preparation of the lower test concentrations. The following treatments were tested: Dilution 1:22, 1:10, 1:4.6, 1:2.2 and the undiluted filtrate in parallel to a control. The test method was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000. Only the highest test concentration was analytically measured since it was determined as the NOEC in this test. At the start of the test, the analytically determined concentration of the test item in the undiluted filtrate was 1.7 mg/L. At the end of the test, 1.2 mg/L were found. The mean measured concentration (calculated as geometric mean) was of 1.4 mg/L. The test item had no significant inhibitory effect on the growth of the algae (average growth rate and yield) during the test period of 72 hours up to highest tested concentration, 1.4 mg/L. Therefore, the 72 -hour NOEC was greater than or equal to 1.4 mg/L and the 72 -hour EC50 was greater than 1.4 mg/L.
The results of the available reliable data for the source and target substances are identical for biodegradation in water and short-term toxicity to aquatic invertebrates. No acute effects were observed for both compounds up to the attainable limit of solubility in test medium (see ECHA disseminated dossier of the source substance EC#223 -118 -6). The similarity of the structural, physico-chemical properties and ecotoxicity profiles between both substances is pronounced. On this basis, it's considered suitable and scientifically justified to read-across the data between the two substances to fill the toxicity to aquatic algae endpoint in the present dossier (see IUCLID section 13 for justification).
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