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:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item: Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester
Batch Number: 12/34#
Content: 93.3 area-%
CAS RN: 1195231-94-7
Sum formula: C20H35N3O6Si
Molecular weight: 441 g/mol
Appearance: Solid, green powder
Water solubility: 70 mg/L
Stability under test conditions: At pH 7: ca. 40 h half life
Expiry date: 2013-09-17
Recommended storage: Room temperature, avoid moisture, keep dark

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Study design

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

Results and discussion

Effect concentrationsopen allclose all
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.022 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
0.079 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
0.069 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: with 95% confidence limits=0.0326-0.137
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
0.134 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: with 95% confidence limits=0.0743-0.208
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.401 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: with 95% confidence limits=0.293-0.565
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.022 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: Yield
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
0.079 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: Yield
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
0.035 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: Yield
Remarks on result:
other: with 95% confidence limits = <0.0218-0.0623
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
0.043 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: Yield
Remarks on result:
other: with 95% confidence limits=0.0236-0.0645
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.059 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: Yield
Remarks on result:
other: with 95% confidence limits=0.0320-0.0725

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In this study Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (geometric mean measured test item concentrations): The EC50-values with 95 % confidence intervals for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 0.401 (0.293 – 0.565) mg/L and 0.0594 (0.0320 – 0.0725) mg/L, respectively. The NOEC-value for both inhibitions of growth rate and yield after 72 hours was 0.0218 mg/L.
All effect values are given based on geometric mean measured test item concentrations.
Executive summary:

The toxicity of Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester (CAS 1195231-94-7) to the unicellular freshwater green alga Pseudokirchneriella subcapitatawas determined according to the principles of OECD 201 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany from 2013-07-30 to 2013-08-05, with the definitive exposure phase from 2013-07-30 to 2013-08-02. The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours.

The study was conducted under static conditions with an initial cell density of 5297 cells/mL. Based on a preliminary test 5 concentration levels were tested in a geometrical series with a dilution factor of (nominal): 0.100 - 0.316 - 1.00 - 3.16 - 10.0 mg/L corresponding to the geometric mean measured concentrations: 0.0218 - 0.0785 - 0.271 - 0.823 - 3.71 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditionswere within the acceptable limits.

The concentrations of Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl esterwere analytically verified by LC-MS/MS at the test start and the test end of all test concentrations and the control.

The measured concentrations of Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl esterat start of the exposure were in the range of 52 to 58 % and after 72 hours in the range of 8 to 25 % of the nominal values. Therefore, all effect values given are based on the geometric mean measured concentrations after 0 and 72 hours of the test itemCarbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester.