Registration Dossier

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 10-13, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Mitsubishi-Chemical Foods Corporation; 6912911B
- Expiration date of the lot/batch: September 11, 2018
- Purity test date: June 27, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: below 15 degrees C in a cool, dark, well-ventilated space with the container tightly closed
- Solubility and stability of the test substance in the solvent/vehicle: forms highly viscous solution or gel when mixed with water

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution was prepared by adding 315.999 mg of test item to a 1 L bottle. 1 L of growth medium was added, and the solution stirred for 2 hrs at room temperature.

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM

- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologishces Institut of the University of Gottingen, Albrecht von Haller Institut, Untere Klarspule 2, D-37073 Gottingen, Catalog No 61.81 SAG

ACCLIMATION
- Acclimation period: 4 days
- Culturing media and conditions (same as test or not): same

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h

Test conditions

Test temperature:
22 degrees C
pH:
7.73-8.06
Nominal and measured concentrations:
Nominal: 0, 3.16, 10.0, 31.6, 100, 316 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL glass flasks
- Type (delete if not applicable): open (air-permeable silicone-sponge caps)
- Material, size, headspace, fill volume: glass, 250 mL fill volume
- Aeration: no
- Initial cells density: 10,000 cells/mL
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 8


GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified water
Reference substance (positive control):
yes
Remarks:
The sensitivity of the test organism is checked twice a year using 3,5-dichlorophenol.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
133 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): Yes, at 72 hrs first cell debris was visible at all test concentrations.
Reported statistics and error estimates:
ErC50 95%-cl 1243-144 mg/L
EyC50 95%-cl 50.7-61.3 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 72-hr EC50 based on growth rate was 133 mg/L.
Executive summary:

The toxicity to alga of the test substance was determined in an OECD Guideline 201 test. Algae were exposed to 0, 3.16, 10.0, 31.6, 100, 316 mg/L of test substance. Due to difficulties analyzing the test substance, nominal concentrations were reported. The 72 hr EC50 based on growth rate was 133 mg/L, with an NOEC of 10 mg/L.