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Diss Factsheets

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:
09.07.2019 - 19.09.2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane
EC Number:
202-928-3
EC Name:
3,7-dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane
Cas Number:
101-25-7
Molecular formula:
C5H10N6O2
IUPAC Name:
3,7-dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were analyzed with a HPLC-DAD method, implemented under non-GLP and documented finally in the GLP raw data.
All concentration levels and the control were analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (72 hours) with algae.
At the start, samples were taken from one additional replicate of each test item concentration and the control and at the end samples were taken from pooled replicates.

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution of 80.0 mg test item/L was freshly prepared with dilution water (see Table 2). The test solution was treated with ultrasound for 5 minutes at room temperature. The stock solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was negative.
Six concentration levels were tested in a geometrical series with a dilution factor of 2.5: 0.819 - .05 - 5.12 - 12.8 - 32.0 - 80.0 mg/L, corresponding to the geometric mean measured test item concentrations of 0.394 – 1.06 – 2.71 – 6.98 – 20.2 – 58.9 mg/L. The dilution levels are based on the results of a preliminary range finding test (non-GLP).

Test organisms

Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
Origin:
Culture Collection of Algae and Protozoa (CCAP)
SAMS Research Services Ltd
Dunstaffnage Marine Laboratory
Dunbeg, OBAN; Argyll PA37 1QA; Scotland, UK

Study design

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

Test conditions

Hardness:
37 mg CaCO3/L
Test temperature:
21 - 24 °C, controlled at ± 2 °C
pH:
7.66 - 8.64 ; Control 8.15 - 8.8
Conductivity:
143 μS/cm
Nominal and measured concentrations:
Measured Concentrations and Percent of Nominal Concentration of the Test Item 3,7-Dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane during the Definitive Test

Sampling date Fresh media, Old media Geometric mean measured
0 hours 72 hours concentration of the test item
Nominal Meas. conc. % Meas. conc %
test item [mg/L] [mg/L] [mg/L]
concentration
[mg/L]
80.0 77.6 97 44.8 56 58.9
32.0 30.9 97 13.2 41 20.2
12.8 12.5 98 3.89 30 6.98
5.12 5.24 102 1.41 27 2.71
2.05 2.05 100 0.543 26 1.06
0.819 0.809 99 0.192 23 0.394
Control < LOQ < LOQ
Meas. conc. = measured concentration of the test item, mean value of 2 injections, dilution factors taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification of the analytical method (0.100 mg/L of the test item)
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
5.03 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
2.29 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
1.43 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
1.06 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.394 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
1.49 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
0.739 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
0.544 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
1.06 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.394 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
biomass
Results with reference substance (positive control):
EC50-Values of the Reference Item based on nominal concentrations [mg/L], (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.701 0.752 ± 0.534
95% confidence interval 0.660 – 0.750
Yield inhibition
EyC50 0.353 0.405 ± 0.308
95% confidence interval 0.312 – 0.394

SD = Standard deviation

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In this study, the effect values of 3,7-Dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 5.03 (4.66 – 5.41) mg/L and 1.49 (1.31– 1.67) mg/L, respectively. The EC10-values for inhibition of growth rate (ErC10) and yield (EyC10) after 72 hours were 1.43 (1.18 – 1.69) mg/L and 0.544 (0.437 – 0.648) mg/L, respectively. The NOEC for both growth rate and yield was 0.394 mg/L.
Executive summary:

In this study, the effect values of 3,7-Dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 5.03 (4.66 – 5.41) mg/L and 1.49 (1.31– 1.67) mg/L, respectively. The EC10-values for inhibition of growth rate (ErC10) and yield (EyC10) after 72 hours were 1.43 (1.18 – 1.69) mg/L and 0.544 (0.437 – 0.648) mg/L, respectively. The NOEC for both growth rate and yield was 0.394 mg/L.