Registration Dossier

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with detailed documentation (read-across: study conducted with a similar substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Fraunhofer IME

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
no

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: 61.81 SAG
- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologisches Institut of the University at Göttingen, Albrecht von Haller Institut, Göttingen, Germany

Study design

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

Test conditions

Test temperature:
21.5 - 22.0 °C
pH:
Control: 8.31 at test start, 8.17 – 8.63 at test end
Test cultures: initial pH 7.84 - 8.35, at test end 7.95 – 8.61
Nominal and measured concentrations:
50.0, 25.0, 12.5, 6.25 and 3.13 mg/L (nominal concentrations)
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL conical glass flasks
- Type:covered with air-permeable siliconesponge caps
- 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
- Intervals of water quality measurement: pH measured in one test vessel per test concentration including the control. At the end of the test, the solution pH values were measured directly in test vessels. The test culture temperature was measured in one test vessel only at test start

OTHER TEST CONDITIONS
- Photoperiod: continuous illimination
- Light intensity and quality: 8127 - 8221 lux

EFFECT PARAMETERS MEASURED:
Cell concentrations were determined with an electronic particle counter at test start and after 24, 48 and 72 h
Reference substance (positive control):
yes
Remarks:
3,5-dichlorophenol

Results and discussion

Effect concentrationsopen allclose all
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
15.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CI 14.0 - 17.0 mg/L
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
6.32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: yield
Remarks on result:
other: 95% CI 5.87 - 6.79 mg/L
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
4.45 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CI 3.50 - 5.35 mg/L
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
2.98 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: yield
Remarks on result:
other: 95% CI 2.49 - 3.40 mg/L
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
3.13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: growth rate and yield
Results with reference substance (positive control):
ErC50 2.91 mg/L (95% CI 2.35 - 3.63 mg/L)
Reported statistics and error estimates:
EC50, EC20 and EC10: Probit-analysis assuming log-normal distribution
NOEC and LOEC: ANOVA followed by Williams Multiple Sequential t-test
Computer program ToxRat used for the statistical evaluations

Any other information on results incl. tables

Growth inhibition of 3.10, 11.6, 46.8, 72.5 and 80.7 % was observed at 3.13, 6.25, 12.5, 25.0 and 50.0 mg/L respectively. Yield inhibition of 14.2, 45.6, 91.6, 98.2 and 99.0 % was observed at 3.13, 6.25, 12.5, 25.0 and 50.0 mg/L respectively. There were no compound related visual phytotoxic effects.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes