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Toxicity to aquatic algae and cyanobacteria

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Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Feb - 02 Mar 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.3 (Algal Inhibition test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water Accomodated Fraction (WAF): A concentration of 100 mg/L of the test substance 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) to obtain a sterile test substance solution for the algal growth test. The resulting water accommodated fraction was used in the test.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Strain: 86.81 SAG
- Source: obtained from the collection of Algal Cultures, Institute of Freshwater Ecology, University of Göttingen, Göttingen, Germany
Age of inoculum (at test initiation): Exponentially growing liquid preculture were used to inoculate sterile test flasks.
- Method of cultivation: 250 mL flask containing 100 mL of sterile OECD medium inoculated with cell material from axenic slope culture, continuous
illumination from warm white fluorescent tubes (8500 - 9000 lux), temperature: 22 ± 0.2 °C thermocontrolled room, periodically conducted
reference test with potassium dichromate.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Hardness:
not stated
Test temperature:
22 ± 0.2 °C
pH:
8.0 ± 0.2
Nominal and measured concentrations:
Nominal: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Erlenmeyer flask
- Material: glass; Size: 250 mL; Fill volume: 100 mL
- Initial cells density: 10000 - 20000/mL
- No. of vessels per concentration: 3
- No. of vessels per control: 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature was determined in a control flask at the start and at the end of the test. The pH was determined in 1 control flask after sterilization before the test and in all test vessels at the end of the test. Observations of mis-shapen cells and cell-debris were made after 24, 48 and 72 h test duration.

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity and quality: warm white fluorescent tubes (8500-9000 lux)

EFFECT PARAMETERS MEASURED: Algal growth was recorded after 24, 48 and 72 h test duration.
- Determination of cell concentrations: using a spectrophotometer (680 nm wavelength). Aliquots of 5 mL were removed from each test
substance served as controls. The starting cell density was determined using a counting chamber.
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: EL50 (24-72h)
Duration:
72 h
Dose descriptor:
EL0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: EL0 (24-72h)
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: EL50 (24-72h)
Duration:
72 h
Dose descriptor:
EL0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: EL0 (24-72h)
Details on results:
- Exponential growth in the control: yes
- Observation of abnormalities: no

At the WAF loading rate of 100 mg/L no inhibition with respect to algal growth rate and algal cell growth (area under growth curve) compared to the untreated controls were observed. The no-observed-effect concentration for growth rates (ErL0) and biomass production (EbL0) with respect to the loading rate was ≥ 100 mg/L. The EL50 -value was conducted as EL50 (24 -72 h). But the EL50 can also be stated as EL50 (72 h) > 100 mg/L for the algal growth rate and algal cell growth.

Table 1: Cell concentration (A680) in individual test cultures after 24, 48 and 72 h of exposure to the test material. ((b) = Mean absorbance (A680))

Nominal concentration [mg/L]

Code

Cell concentration (A680)

0 h (b)

24 h

48 h

72 h

Control

A

B

C

D

E

0.008

0.008

0.008

0.008

0.008

0.033

0.038

0.038

0.036

0.040

0.228

0.222

0.208

0.212

0.233

0.685

0.733

0.676

0.624

0.694

100

A

B

C

0.008

0.008

0.008

0.040

0.038

0.044

0.224

0.207

0.207

0.700

0.631

0.675

 

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
29 Feb - 02 Mar 2007
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.3 (Algal Inhibition test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water Accomodated Fraction (WAF): A concentration of 100 mg/L of the test substance 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) to obtain a sterile test substance solution for the algal growth test. The resulting water accommodated fraction was used in the test.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Strain: 86.81 SAG
- Source: obtained from the collection of Algal Cultures, Institute of Freshwater Ecology, University of Göttingen, Göttingen, Germany
Age of inoculum (at test initiation): Exponentially growing liquid preculture were used to inoculate sterile test flasks.
- Method of cultivation: 250 mL flask containing 100 mL of sterile OECD medium inoculated with cell material from axenic slope culture, continuous
illumination from warm white fluorescent tubes (8500 - 9000 lux), temperature: 22 ± 0.2 °C thermocontrolled room, periodically conducted
reference test with potassium dichromate.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Hardness:
not stated
Test temperature:
22 ± 0.2 °C
pH:
8.0 ± 0.2
Nominal and measured concentrations:
Nominal: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Erlenmeyer flask
- Material: glass; Size: 250 mL; Fill volume: 100 mL
- Initial cells density: 10000 - 20000/mL
- No. of vessels per concentration: 3
- No. of vessels per control: 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature was determined in a control flask at the start and at the end of the test. The pH was determined in 1 control flask after sterilization before the test and in all test vessels at the end of the test. Observations of mis-shapen cells and cell-debris were made after 24, 48 and 72 h test duration.

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity and quality: warm white fluorescent tubes (8500-9000 lux)

EFFECT PARAMETERS MEASURED: Algal growth was recorded after 24, 48 and 72 h test duration.
- Determination of cell concentrations: using a spectrophotometer (680 nm wavelength). Aliquots of 5 mL were removed from each test
substance served as controls. The starting cell density was determined using a counting chamber.
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: EL50 (24-72h)
Duration:
72 h
Dose descriptor:
EL0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: EL0 (24-72h)
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: EL50 (24-72h)
Duration:
72 h
Dose descriptor:
EL0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: EL0 (24-72h)
Details on results:
- Exponential growth in the control: yes
- Observation of abnormalities: no

At the WAF loading rate of 100 mg/L no inhibition with respect to algal growth rate and algal cell growth (area under growth curve) compared to the untreated controls were observed. The no-observed-effect concentration for growth rates (ErL0) and biomass production (EbL0) with respect to the loading rate was ≥ 100 mg/L. The EL50 -value was conducted as EL50 (24 -72 h). But the EL50 can also be stated as EL50 (72 h) > 100 mg/L for the algal growth rate and algal cell growth.

Table 1: Cell concentration (A680) in individual test cultures after 24, 48 and 72 h of exposure to the test material. ((b) = Mean absorbance (A680))

Nominal concentration [mg/L]

Code

Cell concentration (A680)

0 h (b)

24 h

48 h

72 h

Control

A

B

C

D

E

0.008

0.008

0.008

0.008

0.008

0.033

0.038

0.038

0.036

0.040

0.228

0.222

0.208

0.212

0.233

0.685

0.733

0.676

0.624

0.694

100

A

B

C

0.008

0.008

0.008

0.040

0.038

0.044

0.224

0.207

0.207

0.700

0.631

0.675

 

Description of key information

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of Pentaerythritol, mixed esters with linear and branched fatty acids to aquatic algae are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) was conducted. The target substance is characterized as a tetraester of pentaerythritol and linear and branched fatty acids. The source substance Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) is a triester of trimethylolpropane and C8-C10 fatty acids (even numbered).

This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13.

A study with the source substance Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) was performed according to OECD 201 (non-GLP) is available investigating the toxicity to aquatic algae (Häner, 2007). Desmodesmus subspicatus was exposed to a nominal loading rate of 100 mg/L for 72 h (Water Accommodated Fraction). No effects were observed on growth and biomass after 72 h of incubation resulting in an EL50 (72 h) > 100 mg/L (nominal) and an EL0 (72 h)1000 mg/L (nominal).

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Pentaerythritol, mixed esters with linear and branched fatty acids will not exhibit effects on aquatic algae up to the limit of water solubility.