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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to O.E.C.D. Testing Guideline 201 in compliance with the GLPs.
Justification for type of information:
See read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
No data
Vehicle:
no
Details on test solutions:
water accommodated fraction: loading rated of 10 - 1000 mg/L. Stirred for 69 hours
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
Raphidocelis subcapitata (green algae) was supplied by the Institute of Freshwater Ecology, Windermere (UK) and maintained as a semiaxenic laboratory culture. Three out of each set of four flasks containing WAFs and six controls were inoculated with sufficient R. subcapitata to give an initial concentration of 5000 cells/ml. The flasks were placed in a colled orbital shaker under constant illumination.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
None
Hardness:
No data
Test temperature:
21.0-23.3°C
pH:
8.3
Dissolved oxygen:
No data
Salinity:
Freshwater
Nominal and measured concentrations:
The WAF nominal concentrations (mg/L) were: 0, 10, 30, 100, 300 and 1000.
Details on test conditions:
Algal cultures were exposed in sealed flasks completely filled with 287 ml of test medium including sodium bicarbonate. There were 4 replicate/treatement and 7 for control (test medium + sodium bicarbonate) and 1 blank/concentration. The photoperiod (intensity of irradiation) was continuous (~5000 lux). The test duration was 72 hours with observations made at 0, 24, 48 and 72 hours. Algal cell counts were made with a Coulter Multisizer at observation times of: 0, 24, 48 and 72 hr.
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
> 100 - < 300 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate
Basis for effect:
growth rate
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 - < 300 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 - < 300 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate
Basis for effect:
growth rate
Validity criteria fulfilled:
not specified
Conclusions:
Based on the measurment of growth rate, the 72 hr EC50 for algae > 100 mg/L (pH adjusted) under the conditions of the study. The NOEC was estimated to be 100 mg/L (pH adjusted).
Executive summary:

Water Accomodated Fractions (WAF) of VERSATIC 1019 were evaluated in an O.E.C.D. 201 Testing Guideline "Algal Growth Inhibition Test" under static exposure conditions. Based on the measurment of growth rate, the 72 hr EC50 for algae was >100 mg/L (pH adjusted) under the conditions of the study. The NOEC was estimated to be 100 mg/L (pH adjusted).

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to O.E.C.D. Testing Guideline 201 in compliance with the GLPs.
Justification for type of information:
See read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
No data
Vehicle:
no
Details on test solutions:
100 mg/L of Neononanoic acid was added to test medium and stirred for 48 hours under ambient conditions in a 20 L aspirator. After standing for 1.5-2 hours, the Water Accomodated Fraction stock solution was drawn off (WAF method). Dilutions of the WAF were made in test medium as needed.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
Raphidocelis subcapitata (green algae) was supplied by the Institute of Freshwater Ecology, Windermere (UK) and maintained as a semiaxenic laboratory culture. Three out of each set of four flasks containing WAFs and six controls were inoculated with sufficient R. subcapitata to give an initial concentration of 5000 cells/ml. The flasks were placed in a colled orbital shaker under constant illumination.
Test type:
static
Water media type:
freshwater
Total exposure duration:
72 h
Post exposure observation period:
None
Hardness:
No data
Test temperature:
22.4-23.6°C
pH:
6.6-9.2
Dissolved oxygen:
No data
Salinity:
Freshwater
Nominal and measured concentrations:
The WAF nominal concentrations (mg/L) were: 0, 2.2, 4.6, 10, 22, 46, and 100.
Details on test conditions:
Algal cultures were exposed in sealed flasks completely filled with 287 ml of test medium including sodium bicarbonate. There were 3 replicate/treatement and 6 for control (test medium + sodium bicarbonate) and 1 blank/concentration. The photoperiod (intensity of irradiation) was continuous (5930 lux). The test duration was 72 hours with observations made at 0, 24, 48 and 72 hours. Algal cell counts were made with a Coulter Multisizer at observation times of: 0, 24, 48 and 72 hr.
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate
Basis for effect:
growth rate
Remarks on result:
other: pH adjusted
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate
Basis for effect:
growth rate
Remarks on result:
other: pH adjusted
Details on results:
The measured (geometric mean) test substance concentrations (mg/L) were <0.5, 2.3, 4.3, 9.7, 21, 47 and 97 at 0 hours and decreased on average 2% by 72 hours. The 72 hour NOEL was 46 mg/L (non adjusted pH) and 100 mg/L (pH adjusted)
Reported statistics and error estimates:
The reported area under growth curve (EbC50) > 100 mg/L (pH adjusted).
Validity criteria fulfilled:
not specified
Conclusions:
Based on the most sensitive measurment of area under growth curve, the 72 hr EC50 for algae > 100 mg/L (pH adjusted) under the conditions of the study. The NOEC was estimated to be 100 mg/L (pH adjusted).
Executive summary:

Water Accomodated Fractions (WAF) of Neononanoic acid were evaluated in an O.E.C.D. 201 Testing Guideline "Algal Growth Inhibition Test" under static exposure conditions and with analytical verification test substance concentrations. Based on the most sensitive measurment of area under growth curve, the 72 hr EC50 for algae was >100 mg/L (pH adjusted) under the conditions of the study. The NOEC was estimated to be 100 mg/L (pH adjusted).

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles.
Justification for type of information:
See read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline available
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
Composition of Algal Nutrient Medium


COMPOUND CONCENTRATION ELEMENT CONCENTRATION
(mg/L) (mg/L)

NaNO3 25.500 N 4.200

MgCl2∙6H2O 12.164 Mg 2.904

CaCl2∙2H2O 4.410 Ca 1.202

MgSO4∙7H2O 14.700 S 1.911

K2HPO4 1.044 P 0.186

NaHCO3 15.000 Na 11.001

K 0.469

C 2.143


COMPOUND CONCENTRATION ELEMENT CONCENTRATION
(g/L) (g/L)

H3BO3 185.520 B 32.460

MnCl2∙4H2O 415.610 Mn 115.374

ZnCl2 3.271 Zn 1.570

CoCl2∙6H2O 1.428 Co 0.354

CuCl2∙2H2O 0.012 Cu 0.004

Na2MoO4∙2H2O 7.260 Mo 2.878

FeCl3∙6H2O 160.000 Fe 33.051

Na2EDTA∙2H2O 300.00
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Remarks on exposure duration:
static
Test temperature:
Mean temperature: 23.8C
pH:
7.5
Nominal and measured concentrations:
Nominal: 64.5, 125, 24,7 531, 1054 mg/L
Measured: 62.4, 120, 22, 350, 432 mg/L
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
89 mg/L
Conc. based on:
test mat.
Basis for effect:
cell number
Conclusions:
The 96-h EC50, based on cell counts on day 4 for the test material was calculated to be 89 mg/L.
Executive summary:

The 96-h EC50 for growth rate and biomass for the test material was 89 mg/L.

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
See read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples were taken at the start end end of the 72 h test period.
Vehicle:
no
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Test temperature:
22.6-23.5
pH:
7.7-10.8
Nominal and measured concentrations:
Nominal: 1, 2.2, 4.6, 10, 22, 46, 100 mg/L
Measured: <0.5, 0.98, 3.8, 9.2, 20, 47, 98 mg/L
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
growth rate
Validity criteria fulfilled:
yes
Conclusions:
The 72 h EL50 for R. subcapitata was greater than 100 mg/L.
Executive summary:

The 72 h EL50 for R. subcapitata was greater than 100 mg/L.

Description of key information

Data from neononanoic acid is read across to the C9-13 neofatty acids.  The Klimisch 1 acute 72 hr algal study in 1998 conducted according to O.E.C.D. Testing Guideline 201 with GLP compliance and test substance concetration analytical determination is the most appropriate and reliable study on which to base an algal PNEC.  The EC50 value for this study was >100 mg.L and the NOEC for this study was 100 mg/L.  

Key value for chemical safety assessment

Additional information

Data from neononanoic acid is read across to the C9 -13 neofatty acids. ECHA guidance (RIP 3.2, Chapter R. 10) suggests applying a 1000-fold Assessment Factor to an acute freshwater EC50 value to derive the PNEC. Therefore that freshwater algal PNEC is 100 (mg/L)/1000 = 100 ug/L. To derive a marine algal PNEC from freshwater algae study data, ECHA guidance recommends an Assessment Factor of 10,000-fold. Therefore, the marine algal PNEC based on the freshwater algal EC50 value of 100 mg/L is10 ug/L.

Neodecanoate was tested in an OECD 201 test and the 72 h EL50 for R. subcapitata was greater than 100 mg/L.

Neodecanoate was tested in an OECD 201 test and the 96-h EC50 for growth rate and biomass for the test material was 89 mg/L.

In an OECD 201 test on C10 -20, fatty acids neo the 72 hr EC50 for algae > 100 mg/L (pH adjusted) under the conditions of the study. The NOEC was estimated to be 100 mg/L (pH adjusted).