Registration Dossier

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:
2008-08-05 to 2008-08-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples of each test medium were taken at the start and end of the test. They received no further treatment prior to analysis.
Vehicle:
no
Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Source (laboratory, culture collection): Test organisms were obtained from in-house cultures. The source of the original brood stock was strain UTEX 1648, from the University of Texas at Austin, The Culture Collection of Algae, Botany Department, Austin, Texas, in March 1998. The identity of the species was verified by the supplier.

- Method of cultivation: Algal cultures were maintained at 24+/-2ºC on a rotary shaker set at approximately 100 rpm, under continuous cool white fluorescent lighting at a range of 400 ± 100 foot candles (4300+/-1075 lux). The cultures were periodically transferred axenically to new AAM.

- Culture medium: Algal Assay Medium was prepared based on ASTM guideline E 1218-04. The final concentration of each nutrient in the medium is presented in Appendix A. All stocks used to prepare the medium were prepared with sterile distilled water and were filter sterilized (0.22 μm). Medium was prepared with commercially available distilled water that is analyzed annually for contaminants. No contaminants have been shown to be present which might adversely impact the viability of the cultures or study
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
Not reported
Test temperature:
23.8 to 24.0 °C
pH:
pH at test initiation ranged from 7.4 to 7.5. At test termination, pH in the flasks that contained algae ranged from 8.0 to 9.0 and pH of media blanks ranged from 7.6 to 7.8
Dissolved oxygen:
Not reported
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal test concentrations: 0 (Control), 7.5, 15, 30, 60 and 120 mg/L

Mean measured test concentrations in treated media: 7.9, 18, 28, 57 and 118 mg/L; which is 105, 121, 93, 95 and 98% of nominal.

The results are expressed relative to mean measured concentrations.
Details on test conditions:
TEST SYSTEM

- Test Apparatus: Test vessels were sterile 250-mL Erlenmeyer flasks covered with a sponge closure containing approximately 100 mL of test solution. Test vessels were labeled with the study number, concentration, and replicate.

- Initial cell density: 10000 cells/ml

- Test Conditions: Test vessels were placed in a temperature controlled incubator and positioned on rotary shakers that were set at approximately 100 rpm. In addition, the incubator was set at a temperature of 24+/-2ºC and under continuous cool white fluorescent lighting at a range of 412 – 825 foot-candles (4440 - 8880 lux).

Temperature was measured in a beaker of water adjacent to the shakers in the incubator and light readings were recorded at five indiscriminate areas on the shaker tables daily during the test. Readings of pH were completed on bulk preparations of each treatment group at test initiation. To maintain axenic conditions, pH readings for each test vessel were measured only at 72 hours.

- Observations: Samples for cell counts were collected on Day 0 for the original culture and test inoculums. Samples for cell counts were also collected from each test vessel at 24, 48 and 72 hours (within 1 hour). Samples were diluted with Isoton® II diluent solution and counted immediately using a Coulter® Counter. Dilution volumes were recorded in the raw data. Dilution samples of the medium and diluent blanks were counted at 24, 48, and 72 hours to account for any interference of particles. At test termination, samples were pooled by treatment and visually inspected for atypical cell morphology. Visual examination showed no concentration-dependent changes in shape, color or size.

- Light intensity: 446 to 620 foot-candles
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 118 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: growth rate and biomass
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
>= 118 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: growth rate and biomass
Details on results:
- Exponential growth in the control (for algal test): yes, Control cell density for this study increased 122 fold by 72 hours.
Reported statistics and error estimates:
ECx values at 72 hours were calculated using linear interpolation or estimated by visual examination of the data.

Yield (biomass) and growth rate data were analyzed for normality and homogeneity of variance using the Shapiro-Wilk’s test and Bartlett’s test, respectively. The no observed effect concentration (NOEC) values were determined for growth rate and yield at 72 hours using Dunnett’s test. All statistical analyses were performed using TOXSTAT Version 3.5 software

Table 1. Measurement of Test Concentrations

Nominal

Concentration

(mg/L)

Day 0 Measured Concentration

 (mg/L)

Day 3 Measured Concentration (mg/L)

Mean

Measured

Concentration

(mg/L)

Percent of Nominal

Control

 

ND

ND

--

--

7.5

 

5.9

10

7.9

105

15

 

18

19

18

121

30

 

25

31

28

93

60

55

60

57

95

120

114

122

118

98

ND = Not Detected

 

Table 2. Mean Cell Densities (cells/mL)

Mean Measured Concentration

(mg/L)

 

 

0-hour

24-hour

48-hour

72-hour

Negative Control

~10000

43433

240424

1222333

7.9

~10000

41551

246551

1276867

18

~10000

37384

232924

1216000

28

~10000

38551

217216

1129333

57

~10000

42022

228560

1090778

118

~10000

35773

201429

990800

Algal cell growth in the control was exponential during the 72-h exposure period. Cell densities were used to calculate the average specific growth rates and yield for each test concentration. 

Validity criteria fulfilled:
yes
Conclusions:
A 72-hour EC50 value of >118 mg/L and a NOEC of ≥118 mg/L have been determined for the effects of the test substance on growth rate of Pseudokirchnerella subcapitata.
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
Reason / purpose:
read-across source
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 118 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: growth rate and biomass
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
>= 118 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: growth rate and biomass

Description of key information

EC50 (72 h) > 118 mg/L (measured (arithmetic mean), OECD 201)
NOEC (72 h) ≥ 118 mg/L (measured (arithmetic mean), OECD 201)

Key value for chemical safety assessment

Additional information

There are no data available on toxicity to algae for Diethoxy(dimethyl)silane (CAS 78-62-6). In accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 “Grouping of substances and read-across” and in accordance with the read across assessment framework (RAAF, ECHA 2017) a read-across from the analogue substance dimethylsilanediol (CAS 1066-42-8) has been applied to support the environmental hazard assessment of diethoxy(dimethyl)silane (CAS 78-62-6). Details on the read across justification can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
The study with the analogue substance dimethylsilanediol (CAS 1066-42-8) was performed according to OECD 201 (GLP). Pseudokirchneriella subcapitata was exposed to the substance at concentrations of 7.5, 15, 30, 60 and 120 mg/L. The test concentration remained stable for the duration of the study resulting in a mean measured test concentrations between 93 - 121% of nominal. No inhibition of growth rate was recorded after 72 h resulting in an EC50 (72 h) > 118 mg/L and a NOEC (72 h) ≥ 118 mg/L.

Based on these results of the analogue substance, diethoxy(dimethyl)silane (CAS 78-62-6) is not assumed to be harmful to aquatic algae.