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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Restriction: No analytical confirmation of exposure concentrations.
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Details on sampling:
not applicable
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A single 1,000 mg/L WAF was formulated by combining 0.5 g of test material and 500 mL of dilution water in a glass mixing vessel equipped with a magnetic stirrer (the vortex extended approximately 25% of the distance from the surface to the bottom of the mixing vessel). The mixture was stirred for approximately 24 hours and allowed to settle for approximately 1 hour. Following the settling period the water phase containing the WAF was removed from the mixing vessel with a siphon using care to exclude any material on the surface, bottom, or sides of the mixing vessel. Test media was prepared at 0.10, 1.0, 10, 100, and 1,000 mg/L by combining the appropriate volume of the 1,000 mg/L WAF and dilution water.
- Controls: Dilution water control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Dilution control, 1.10, 1.0, 10, 100, and 1,000 mg/L.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The 1,000 mg/L WAF was cloudy throughout the test. No other insoluble material was observed during the test.

Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: Green algae
- Strain: Selenastrum capricornutum
- Source (laboratory, culture collection): University of Texas at Austin and delivered to T.R. Wilbury on April 11, 1995.
- Age of inoculum (at test initiation): The inoculum used for the test was from a single source that had been growing for 8 days prior to testing.
- Method of cultivation: No data

ACCLIMATION
- Acclimation period: Approximately 14 days
- Culturing media and conditions: same as test media.
- Any deformed or abnormal cells observed: No
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
not applicable
Hardness:
no data
Test temperature:
24.0°C at test initiation to 23.9°C at test termination
pH:
7.3 - 10.2
Dissolved oxygen:
no data
Salinity:
no data
Nominal and measured concentrations:
nominal: 0.10, 1.0, 10, 100 and 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 125 500 mL glass Erlenmeyer flasks
- Type: open
- Fill volume: less than 50 % of vessel volume
- Aeration: Rotary shaker adjusted to 100 ppm in an incubator
- Type of flow-through: Static
- Renewal rate of test solution: None
- Initial cells density: 10, 000 cells/mL
- Control end cells density: 1,804,000 cells/mL
- No. of organisms per vessel: 10,000 cells/mL
- No. of vessels per concentration (replicates): 2 Replicates
- No. of vessels per control (replicates): 2 Replicates
- No. of vessels per vehicle control (replicates): None

GROWTH MEDIUM
- Standard medium used: Yes, sterile enriched media identical to media used for this test and maintained at test conditions for at lest 14 days before the definitive test. The inoculum used for the test was from a single source that had been growing for 8 days prior to testing.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used for acclimation of test organisms and for all toxicity testing was sterile enriched media with a pH of 7.5. Dilution water was analysed for particulate matter at the start of the test and media from a control vessel was analysed for particulate matter at the end of the test.

- Total organic carbon: non detect
- Particulate matter: non detect at 0-hr; 33 mg/L at 96-hr
- Metals: all non detect; iron 0.03 mg/L
- Pesticides: non detect
- Chlorine: non detect
- Alkalinity: no data
- Ca/mg ratio: no data
- Conductivity: NA
- Culture medium different from test medium: No
- Intervals of water quality measurement: Start and end of test.


OTHER TEST CONDITIONS
- Sterile test conditions: Yes
- Adjustment of pH: No
- Photoperiod: 24 hour’s light
- Light intensity and quality: Approximately 400 foot-candles
- Salinity (for marine algae): NA


EFFECT PARAMETERS MEASURED: Growth rate

- Calculations and Statistical Methods: The average specific growth rate was calculated as the natural log of the number of cells/mL at 72 and 96 hours minus the natural log of the number of cells/ml at 0 hours divided by the exposure period. The percent change from the control was calculated by subtracting the treatment average specific growth rate from the control average specific growth rate, dividing the difference by the average specific growth rate in the control, and multiplying that value by 100. The EC50 and NOEC values were calculated using nominal concentrations of test substance, when warranted. The values were computed twice, once using the average number of cells/mL at each concentration expressed as a percent of the control and a second time using the average specific growth rate expressed as the percent change from the control. The binomial/nonlinear interpolation method (Stephan, 1983) was used to calculate EC50 values. The slope of the 96-hour dose response curve (cell density) was computed using the probit method. The no observed effect concentration (NOEC) is the highest concentration of test substance that allowed cell growth equal to at least 90% of the control growth.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Each concentration approximately 10 % of the next higher concentration.
- Range finding study
- Test concentrations: 1.10, 1.0, 10, 100, 1,000 mg/L
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
270 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: cell density
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: cell density
Details on results:
- Exponential growth in the control (for algal test): Yes
- Observation of abnormalities (for algal test): No
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: After 120 hours, examination of the media from the flask containing a 0.50 mL subsample of test media from the flask containing the 1,000 mg/L Alkyltin MA WAF and 50 mL of fresh media contained 472,000 algal cells/mL, indicating that the effect of the test material at the concentration was algistatic.
- Any stimulation of growth found in any treatment: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The 1,000 mg/L WAF was cloudy throughout the test. No other insoluble material was observed during the test.
- Effect concentrations exceeding solubility of substance in test medium: greater than 1,000 mg/L

Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
Data were evaluated using the binomial/non-linear interpolation method (Stephan 1983). The slope of the 96-h dose response curve (cell density) was computed using the probit methd. The NOEC was defined as the highest concentration tested that allowed cell growth equal to at least 90% of the control growth.

Mean cell growth data (number of cells/ml x 10^3) at 72 hours, by nominal concentration of the WAF tested:

Control (0 mg/L): 838 (72 h)

0.10 mg/L: 811 (72 h)

1.0 mg/L: 822 (72 h)

10 mg/L: 803 (72 h) 100 mg/L: 465 (72 h)

1000 mg/L: <13 (72 h) 

Average specific growth rate at 72 hours, by nominal concentration of the WAF tested:

Control (0 mg/L): 0.062 (72 h)

0.10 mg/L: 0.061 (72 h)

1.0 mg/L: 0.061 (72 h)

10 mg/L: 0.061 (72 h)

100 mg/L: 0.053 (72 h)

1000 mg/L: 0.004 (72 h)

Validity criteria fulfilled:
yes
Conclusions:
Exposure of the freshwater alga, Selenstrum capricornutum, to the test material resulted in a 72-h EC50 based on growth rate of 270 mg/L and a 72-h NOEC based on growth rate of 10 mg/L .
Executive summary:

The toxicity of the test material to the freshwater alga, Selenastrum capricornutum, was investigated in a study which was conducted in accordance with the standardised guideline OECD 201, under GLP conditions. The test was performed under static conditions with the WAF of 0.10, 1.0, 10, 100 and 1000 mg/L mixtures of test material and water. Cell counts were made at 0, 72 and 96 hours with a haemocytometer.

A 72-h EC50 based on the growth rate was determined to be 270 mg/L with a no observed effect concentration at 72-h of 10 mg/L based on growth rate.

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: Study conducted on read-across material
Justification for type of information:
Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4), see attached justification.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
270 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: cell density
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: cell density

Description of key information

Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583 -35 -4)

A 72-h EC50 based on the growth rate was determined to be 270 mg/L with a no observed effect concentration at 72-h of 10 mg/L based on growth rate.

Key value for chemical safety assessment

EC50 for freshwater algae:
270 mg/L
EC10 or NOEC for freshwater algae:
10 mg/L

Additional information

Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583 -35 -4)

The toxicity of the test material to the freshwater alga, Selenastrum capricornutum, was investigated in a study which was conducted in accordance with the standardised guideline OECD 201, under GLP conditions. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

The test was performed under static conditions with the WAF of 0.10, 1.0, 10, 100 and 1000 mg/L mixtures of test material and water. Cell counts were made at 0, 72 and 96 hours with a haemocytometer.

A 72-h EC50 based on the growth rate was determined to be 270 mg/L with a no observed effect concentration at 72-h of 10 mg/L based on growth rate.