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EC number: 948-383-1 | CAS number: -
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- Endpoint summary
- Stability
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- 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
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- 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:
- weight of evidence
- Study period:
- 07 - 10 Nov 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP Guideline study: Analytical purity is not stated. Dissolved test substance concentration is not measured. Only two replicates are used.
- 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)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- But conducted in accordance with ISO/IEC 17025
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance in a concentration of 100 mg/L was moderately stirred in algal medium for 24 h at room temperature. After this incubation time, the undissolved materials were removed by sterile filtration (0.45 µm). The resulting Water Accomodated Fraction was used in this test. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: 88.81 SAG
- Source: Collection of algal cultures, Institute of Freshwater Ecology, University of Göttingen, Germany
- Method of cultivation: Cultivated in 100 mL flasks containing 50 mL of sterile OECD medium; inoculated with cell material from axenic slope cultures under continuous light (8500 - 9000 lux) and at a temperature of 22 ± 0.2 °C. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 22 ± 0.2 °C
- pH:
- 8.0 ± 0.2
- Nominal and measured concentrations:
- Nominal: 100 mg/L loading rate WAF
- Details on test conditions:
- TEST SYSTEM
- Test vessel: flask
- Material: glass; Size: 250 mL; Fill volume: 100 mL test medium
- Initial cells density: 10000 - 20000 cells/mL
- Control end cells density: Increase of cell density at a factor of 35.3 - 37.9
- No. of vessels per concentration: 3
- No. of vessels per control: 5
GROWTH MEDIUM
- Standard medium used: yes, recommended medium in OECD guideline 201
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature and pH were determined in a control flask at the start and at the end of the test.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: warm white fluorescent light of 8500 - 9000 lux
EFFECT PARAMETERS MEASURED: The cell concentration was measured every 24 h from aliquots of 5 mL, which were removed from each test flask under sterile conditions.
- Determination of cell concentrations: Spectrophotometer (680 nm wavelength)
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: This study represents a limit test. Therefore, no range finding test was conducted. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: EL50 (24-72 h)
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: NOELR (24-72 h)
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- biomass
- Remarks on result:
- other: EL50 (24-72 h)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the analogue justification attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: EL50 (24-72h)
- Remarks:
- RA-A, CAS 95912-89-3, Oleon, 2006
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: NOELR (24-72h)
- Remarks:
- RA-A, CAS 95912-89-3, Oleon, 2006
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: supporting RA-A, CAS 95912-89-3, Oleon, 2007
- Remarks:
- EL50 (24-72h)
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: supporting RA-A, CAS 95912-89-3, Oleon, 2007
- Remarks:
- NOELR (24-72h)
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: supporting RA-A, CAS 95912-89-3, Nyco, 2008
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: supporting RA-A, CAS 95912-89-3, Nyco, 2008
- Conclusions:
- The key values for the toxicity to aquatic algae are an EL50 (72 h) of > 100 mg/L (nominal) and NOELR ≥ 100 mg/L (nominal), based on experimental data with one structurally and chemically closely related source substances (OECD 201, D. subspicatus and P. subcapitata).
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 6 - 9 Feb 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP Guideline study: The test substance was not analytically monitored and no purity of the test substance is given.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Aqueous solution is saturated with the test substance by dynamic contact setting with a known test substance amount. The preparation consists of 68 h of gentle agitation by magnetic stirring (30 rpm - 60 rpm), followed by 4 h of phase separation. The aqueous phase, containing the soluble substances (Water Accomodated Fraction) is taken to perform the test.
- Differential loading: The test solution is identified according to its loading ratio (massic proportions of substance to be tested/ test medium introduced into the diphasic reactor) while operating the WAF. The implemented loaded ratio is: 1.042/1000. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Source: Microbiotests Inc., Venecoweg 19, 9810 Nazareth, Belgium
- Age of inoculum (at test initiation): not stated
- Method of cultivation: dispersion of agal cells into dilution water
ACCLIMATION
- Acclimation period: 4 d
- Culturing media and conditions (same as test or not): same
- Any deformed or abnormal cells observed: none - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Hardness:
- not stated
- Test temperature:
- 23 ± 2 °C
- pH:
- 8.1 at test inition
8.8 - 8.9 end of test - Nominal and measured concentrations:
- Nominal: 1000 mg/L loading rate WAF
- Details on test conditions:
- TEST SYSTEM
- Test vessel: polyacrylate cells with a top and 10 cm of path length (35 mL volume)
- Initial cells density: 10000 cells/mL
- Control end cells density: The mean of the growth rate of the control, after 72 h of assay, is over 1.4 per day.
- No. of vessels per concentration: 6
- No. of vessels per control: 6
GROWTH MEDIUM
- Standard medium used: yes, as recommended in guideline
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: not stated
- Intervals of water quality measurement: The pH of the control and the test solution were measured at the beginning and the pH of one vial of each lot was measured at the end of the test (72 h).
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: contiuous
- Light intensity and quality: 8000 lux, white light with spectra from 400 nm to 700 nm
EFFECT PARAMETERS MEASURED: Algal growth was measured after 24, 48 and 72 h test duration using spectrophotometry and microscopic examination.
- Determination of cell concentrations: spectrophotometer (at 670 nm) - Reference substance (positive control):
- not specified
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Details on results:
- - Observation of abnormalities: No particular effects have been observed during the test.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 19 - 22 Dec 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP Guideline study: Analytical purity is not stated. Dissolved test substance concentration is not measured. Only two replicates are used.
- 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)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- But conducted in accordance with ISO/IEC 17025
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance in a concentration of 100 mg/L was moderately stirred in algal medium for 24 h at room temperature. After this incubation time, the undissolved materials were removed by sterile filtration (0.45 µm). The resulting Water Accomodated Fraction was used in this test. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: 88.81 SAG
- Source: Collection of algal cultures, Institute of Freshwater Ecology, University of Göttingen, Germany
- Method of cultivation: Cultivated in 100 mL flasks containing 50 mL of sterile OECD medium; inoculated with cell material from axenic slope cultures under continuous light (8500 - 9000 lux) and at a temperature of 22 ± 0.2 °C. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 22 ± 0.2 °C
- pH:
- 8.0 ± 0.2
- Nominal and measured concentrations:
- Nominal: 100 mg/L loading rate WAF
- Details on test conditions:
- TEST SYSTEM
- Test vessel: flask
- Material: glass; Size: 250 mL; Fill volume: 100 mL test medium
- Initial cells density: 10000 - 20000 cells/mL
- Control end cells density: Increase of cell density at a factor of 35.3 - 37.9
- No. of vessels per concentration: 3
- No. of vessels per control: 5
GROWTH MEDIUM
- Standard medium used: yes, recommended medium in OECD guideline 201
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature and pH were determined in a control flask at the start and at the end of the test.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: warm white fluorescent light of 8500 - 9000 lux
EFFECT PARAMETERS MEASURED: The cell concentration was measured every 24 h from aliquots of 5 mL, which were removed from each test flask under sterile conditions.
- Determination of cell concentrations: Spectrophotometer (680 nm wavelength)
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: This study represents a limit test. Therefore, no range finding test was conducted. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: EL50 (24-72 h)
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth rate
- Remarks on result:
- other: EL50 (24-72 h)
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- biomass
- Remarks on result:
- other: EL50 (24-72 h)
Referenceopen allclose all
Table 1: Average specific growth rates between 24 and 72 h
Nominal concentration [mg/L] |
Code |
Specific growth rate (x 0.01) |
Coefficient of correlation (R) |
Inhibition [%] |
Mean value [%] |
Standard deviation [%] |
Control |
A |
6.48 |
1.000 |
1.0 |
0 |
2.5 |
B |
6.53 |
0.999 |
0.2 |
|||
C |
6.75 |
0.998 |
-3.2 |
|||
D |
6.63 |
1.000 |
-1.4 |
|||
E |
6.33 |
1.000 |
3.3 |
|||
100 |
A |
6.75 |
1.000 |
-3.1 |
-0.5 |
2.9 |
B |
6.37 |
1.000 |
2.7 |
|||
C |
6.62 |
0.995 |
-1.2 |
Table 1: Growth inhibition in the treatment
Treatment (1.042 g/L) |
Inhibition [%] |
Test item 1 |
7.2 |
Test item 2 |
10.5 |
Test item 3 |
0.4 |
Test item 4 |
10.9 |
Test item 5 |
6.4 |
Test item 6 |
8.8 |
Mean |
7.4 |
Std deviation |
3.9 |
Table 1: Average specific growth rates between 24 and 72 h
Nominal concentration [mg/L] |
Code |
Specific growth rate (x 0.01) |
Coefficient of correlation (R) |
Inhibition [%] |
Mean value [%] |
Standard deviation [%] |
Control |
A |
6.20 |
1.000 |
2.8 |
0.0 |
1.8 |
B |
6.40 |
1.000 |
-0.3 |
|||
C |
6.49 |
0.998 |
-1.7 |
|||
D |
6.45 |
0.999 |
-1.1 |
|||
E |
6.36 |
1.000 |
0.3 |
|||
100 |
A |
6.52 |
0.999 |
-2.2 |
-1.8 |
2.2 |
B |
6.34 |
1.000 |
0.7 |
|||
C |
6.62 |
1.000 |
-3.8 |
Description of key information
Key value for chemical safety assessment
Additional information
There is no study available, in which the toxicity of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) to algae and cyanobacteria was assessed. Therefore, read-across to the structurally and chemically closely related source substance Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by similar chemical structure and is therefore considered a suitable representative for the assessment of the short-term toxicity of the target substance to fish. A detailed read-across justification in provided in IUCLID section 13.
Three experimental studies investigating the toxicity of the source substance Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) to freshwater algae are available. The two key studies were conducted under static conditions according to OECD guideline 201 using Desmodesmus subspicatus as test organism. A 100 mg/L loading rate Water Accommodated Fraction (WAF) was used in a limit test. In both studies, no growth rate inhibition was observed in the treatment compared to the control. Hence, based on growth rate, the EL50 (72 h) is determined to be > 100 mg/L and the NOELR (72 h) is determined to be≥100 mg/L loading rate based on the nominal concentration. This result is supported by an additional study, which was conducted under static conditions according to OECD guideline 201 using Pseudokirchnerella subcapitata as test organism. A 1000 mg/L loading rate WAF was used in a limit test. Based on growth rate, the EL50 (72 h) was determined to be > 1000 mg/L and the NOELR (72 h) was determined to be≥1000 mg/L loading rate based on the nominal concentration. Based on these results it can be concluded that no toxicological effects on algae are expected up to the limit of water solubility for Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1).
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.
