Fatty acids, C8-10-(even numberd), Esters with pentaerythritol and adipic acid

Toxicity to aquatic algae and cyanobacteria

Link to relevant study record(s)

Reference

Reference 1

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)

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

Reference 2

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).

Reference 3

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.

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

Reference 4

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)

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

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).