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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
10 Jan - 12 Apr 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP-Guideline study with acceptable restrictions (test substance was slightly degraded in the highest test concentration)
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: stock solution - control - 0.59 - 0.99 - 1.8 - 2.9 - 5.3 mg/L
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg of the test substance was dissolved in 1 L deionised water and stirred for approx. 18 h. The solution was filtered and nominal test substance concentrations were calculated based on the DOC content of stock solution.
- Eluate: No
- Differential loading: No
- Controls: yes, algae growth medium control
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: green algae
- Strain: CHODAT (86.81 SAG)
- Source (laboratory, culture collection): Initially obtained from "Institut für Wasser-, Boden- und Lufthygiene Berlin, Germany.
- Method of cultivation: 3 days before the start of the study a pre-culture was prepared by inoculating from a stock culture (cell density: approx. 20000 cells/mL).
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Test temperature:
22.5 - 22.8 °C
pH:
7.9 - 8.3 (at the beginning)
8.7 - 9.2 (at test termination)
Nominal and measured concentrations:
nominal: control - 0.59 - 0.99 - 1.8 - 2.9 - 5.3 mg/L
measured:
control: 0 mg/L (0 h)
0.59 mg/L test concentration: 0.085 mg/L (0 h), 1.01 mg/L (72 h)
0.99 mg/L test concentration: 0.82 mg/L (0 h), 0.97 mg/L (72 h)
1.8 mg/L test concentration: 1.60 mg/L (0 h), 1.52 mg/L (72 h)
2.9 mg/L test concentration: 3.05 mg/L (0 h), 2.22 mg/L (72 h)
5.3 mg/L test concentration: 5.77 mg/L (0 h), 2.81 mg/L (72 h)
Details on test conditions:
TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Initial cells density: 2E+04 cells/mL
- Control end cells density: 65^10-4 cells/mL
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 8

GROWTH MEDIUM
- Standard medium used: yes, according to guideline

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Light intensity and quality: approx. 8000 lux white light

EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Photometric determination of the absorbance at 685 nm to determine cell concentrations after 0, 24, 48 and 72 h; the values were expressed in cells/mL with a calibration curve.
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
NOELR
Effect conc.:
>= 5.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 5.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Details on results:
- Exponential growth in the control (for algal test): yes

No growth inhibitory effects were observed even at the highest test concentration. Therefore, the NOEC based on nominal concentrations is >= 5.3 mg/L. But the measured concentrations did not remain within 80 -120% of nominal. Therefore, the effect concentration should be based on the geometric mean of the measured concentrations at the start and at the end of the test, resulting in a NOEC >= 4.02 mg/L and an EC50 of > 4.02 mg/L.

Table 1: Nominal and measured concentrations

nominal concentrations

measured concentrations after 0 h [mg/L]

measured concentrations after 72 h [mg/L]

filtered stock solution

5.85

--

control

0

--

0.59

0.085

1.01

0.99

0.82

0.97

1.9

1.6

1.52

2.9

3.05

2.22

5.3

5.77

2.81

Validity criteria fulfilled:
yes
Conclusions:
After 72 hours the EL50 was determined to be greater than 5.3 mg/L and the NOELR was determined to be 5.3 mg/L.
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul - 28 Aug 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
GLP Guideline study with acceptable restrictions (Calculation of test concentration, No information on filter).
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Stock solution was sampled/measured once prior testing.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 1 g/L was prepared, stirred for 18 h and was subsequently filtered.
- Eluate: no
- Differential loading: no
- Controls: yes, water control
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: green algae
- Strain: CHODAT 86.81 SAG
- Source: Own breeding. Originally obtained from the Institut für Wasser-, Boden-, und Lufthygiene, Berlin, Germany.

ACCLIMATION
- Acclimation period: 3 d
- Culturing media and conditions: sames as test
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Test temperature:
23.5 - 23.8 °C
pH:
test start: 7.7 - 7.8
test end: 9.3
Nominal and measured concentrations:
nominal: 0, 1000 mg/L
measured: 3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: sterile conical flasks
- Initial cells density: 2x10^4 cells/mL
- Control end cells density: 93x10^4
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 8

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline 92/69/EWG C.3
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: continuous light
- Light intensity and quality: approx. 8000 lux, white

EFFECT PARAMETERS MEASURED: Inhibition of growth based on the cell growth and growth rate after 24, 48 and 72 h.
- Determination of cell concentrations: The cell count was determined photometrically at a wavelength of 685 nm.
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
EL10
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EL10
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
biomass
Details on results:
- Exponential growth in the control: yes
- Any stimulation of growth found in any treatment: yes, in the test concentration of 3.0 mg/L.
Validity criteria fulfilled:
yes
Conclusions:
After 72 hours the EL50 was determined to be > 3 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
Study period:
22 Jul - 28 Augl 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
GLP Guideline study with acceptable restrictions (Calculation of test concentration, No information on filter).
Justification for type of information:
Please refer section 13 for read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Stock solution was sampled/measured once prior testing.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 1 g/L was prepared, stirred for 18 h and was subsequently filtered.
- Eluate: no
- Differential loading: no
- Controls: yes, water control
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: green algae
- Strain: CHODAT 86.81 SAG
- Source: Own breeding. Originally obtained from the Institut für Wasser-, Boden-, und Lufthygiene, Berlin, Germany.

ACCLIMATION
- Acclimation period: 3 d
- Culturing media and conditions: sames as test
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Test temperature:
23.5 - 23.8 °C
pH:
test start: 7.7 - 7.8
test end: 9.3
Nominal and measured concentrations:
nominal: 0, 1000 mg/L
measured: 3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: sterile conical flasks
- Initial cells density: 2x10^4 cells/mL
- Control end cells density: 93x10^4
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 8

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline 92/69/EWG C.3
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: continuous light
- Light intensity and quality: approx. 8000 lux, white

EFFECT PARAMETERS MEASURED: Inhibition of growth based on the cell growth and growth rate after 24, 48 and 72 h.
- Determination of cell concentrations: The cell count was determined photometrically at a wavelength of 685 nm.
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
EL10
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EL10
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
biomass
Details on results:
- Exponential growth in the control: yes
- Any stimulation of growth found in any treatment: yes, in the test concentration of 3.0 mg/L.
Validity criteria fulfilled:
yes
Conclusions:
After 72 hours the EL50 was determined to be > 3 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
Study period:
10 Jan - 12 Apr 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP-Guideline study with acceptable restrictions (test substance was slightly degraded in the highest test concentration)
Justification for type of information:
Please refer section 13 for read across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: stock solution - control - 0.59 - 0.99 - 1.8 - 2.9 - 5.3 mg/L
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg of the test substance was dissolved in 1 L deionised water and stirred for approx. 18 h. The solution was filtered and nominal test substance concentrations were calculated based on the DOC content of stock solution.
- Eluate: No
- Differential loading: No
- Controls: yes, algae growth medium control
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: green algae
- Strain: CHODAT (86.81 SAG)
- Source (laboratory, culture collection): Initially obtained from "Institut für Wasser-, Boden- und Lufthygiene Berlin, Germany.
- Method of cultivation: 3 days before the start of the study a pre-culture was prepared by inoculating from a stock culture (cell density: approx. 20000 cells/mL).
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Test temperature:
22.5 - 22.8 °C
pH:
7.9 - 8.3 (at the beginning)
8.7 - 9.2 (at test termination)
Nominal and measured concentrations:
nominal: control - 0.59 - 0.99 - 1.8 - 2.9 - 5.3 mg/L
measured:
control: 0 mg/L (0 h)
0.59 mg/L test concentration: 0.085 mg/L (0 h), 1.01 mg/L (72 h)
0.99 mg/L test concentration: 0.82 mg/L (0 h), 0.97 mg/L (72 h)
1.8 mg/L test concentration: 1.60 mg/L (0 h), 1.52 mg/L (72 h)
2.9 mg/L test concentration: 3.05 mg/L (0 h), 2.22 mg/L (72 h)
5.3 mg/L test concentration: 5.77 mg/L (0 h), 2.81 mg/L (72 h)
Details on test conditions:
TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Initial cells density: 2E+04 cells/mL
- Control end cells density: 65^10-4 cells/mL
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 8

GROWTH MEDIUM
- Standard medium used: yes, according to guideline

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Light intensity and quality: approx. 8000 lux white light

EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Photometric determination of the absorbance at 685 nm to determine cell concentrations after 0, 24, 48 and 72 h; the values were expressed in cells/mL with a calibration curve.
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
NOELR
Effect conc.:
>= 5.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
> 5.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(WAF)
Basis for effect:
growth rate
Details on results:
- Exponential growth in the control (for algal test): yes

No growth inhibitory effects were observed even at the highest test concentration. Therefore, the NOEC based on nominal concentrations is >= 5.3 mg/L. But the measured concentrations did not remain within 80 -120% of nominal. Therefore, the effect concentration should be based on the geometric mean of the measured concentrations at the start and at the end of the test, resulting in a NOEC >= 4.02 mg/L and an EC50 of > 4.02 mg/L.

Table 1: Nominal and measured concentrations

nominal concentrations

measured concentrations after 0 h [mg/L]

measured concentrations after 72 h [mg/L]

filtered stock solution

5.85

--

control

0

--

0.59

0.085

1.01

0.99

0.82

0.97

1.9

1.6

1.52

2.9

3.05

2.22

5.3

5.77

2.81

Validity criteria fulfilled:
yes
Conclusions:
After 72 hours the EL50 was determined to be greater than 5.3 mg/L and the NOELR was determined to be 5.3 mg/L.

Description of key information

No toxic effects to aquatic algae up to the limit of water solubility.

Key value for chemical safety assessment

EC10 or NOEC for freshwater algae:
3 mg/L

Additional information

Since no studies investigating the toxicity to aquatic algae and cyanobacteria of the test substance are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across conducted to the two structurally related substances butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7). This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue justification in IUCLID Section 13.

The study with butylene glycol dicaprylate / dicaprate was performed as a limit test according to EU Method C.3 using the freshwater algae Scenedesmus subspicatus (Scholz, 1997). A test substance concentration of 1000 mg/L (nominal) and 3 mg/L (measured, based on TOC content) respectively, did not result in any effects on the growth rate and biomass after 72 h resulting in an EL10/50 > 3 mg/L (measured, initial). The recovery rate in the stability test was > 80% and the concentration after 48 and 72 h did not differ more than 20%. Therefore, the test substance was bioavailable throughout the test.

The second study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene was performed according to the EU Method C.3 under GLP conditions (Scholz, 1995). The green algae Scenedesmus subspicatus was exposed to a Water Accommodated Fraction (WAF) of nominal 5.3 mg/L and subsequent dilutions for 72 h. No effects on the growth rate of S. subspicatus up to the limit of water solubility were observed resulting in an ELr50 > 5.3 mg/L and a NOELR of ≥ 5.3 mg/L.

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that the test substance will not exhibit toxic effects to aquatic algae up to the limit of water solubility.