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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
not specified
GLP compliance:
yes
Analytical monitoring:
not specified
Vehicle:
no
Details on test solutions:
Due to the lack of toxicity observed in preliminary range-finding tests (0.01 to 1000 mg/l concentrations tested) OECD Limit Tests were conducted using direct addition of material.
100 mg/l
Test organisms (species):
Daphnia magna
Details on test organisms:
SPECIES: Daphnia magna
ACCLIMATION/TEST WATER: Hard Syntetic Freshwater
FEEDING PRIOR TO TEST: YCT + Selenastrum capricornutum
FEEDING DURING TEST: None -YCT + Selenastrum 2+ h before test
SOURCE: CI Stock cultures
ACCLIMATION TEMP (°C ): 20
BROOD RELEASE START DATE & TIME: 3/30/18 16:00
BROOD RELEASE END DATE & TIME: 3/31/18 10:30
DATE/TIME WATER ADDED: 3/31/18 13:59
DATE/TIME ANIMALS ADDED: 3/31/18 14:17
ANIMAL AGE WINDOW: 18h 30m
MAX AGE AT TEST START: 22h 17m
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
19 - 21
pH:
8.00 - 8.28
Dissolved oxygen:
7.2 - 8.9 mg/L
Conductivity:
568 - 579 uS/cm
Reference substance (positive control):
yes
Remarks:
KCl
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Conclusions:
The EC50 was greater than the test concentration of 100 mg/l.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
dark clear liquid

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
no
Details on test solutions:
Test chamber: 250 ml glass flask
Test solution vol. (25 ml min): 100 ml:
Photoperiod: 24L:0D
Shaker Table Setting (rpm): 100

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
SPECIES: Selenastrum capricornutum (Pseodokirchneriella subcapitata)
TEST WATER: AAP
ILLUMINATION (lux): 450
LIGHT METER NO.: 24
ALGAE SOURCE: CBI Stock cultures (U. Texas)
ACCLIMATION TEMP (°C ): 24
A. INOC. CONC. COUNT (cells/ml x 10000): 510.0
B. INOCULATION VOLUME (ml): 1.0
INITIAL CONC. (cells/ml)(A x B/100): 51000.0

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h

Test conditions

Test temperature:
25°C
pH:
7.60 - 10.24
Nominal and measured concentrations:
100 mg/L nominal
Reference substance (positive control):
yes
Remarks:
KCl

Results and discussion

Effect concentrations
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate

Any other information on results incl. tables

Due to the limited solubility of the OECD Limit Tests were conducted using direct addition ofmaterial. Limit Tests were conducted. Sufficient replicates were tested (6 replicates for algae) to allow for hypothesis testing and confident demonstration that the EC50/LC50 was greater than the test concentration of 100 mg/l.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC50/LC50 was greater than the test concentration of 100 mg/l