1,2,3-Oxadiazolium, 5-amino-3-(4-morpholinyl)-, chloride (1:1)

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline- and GLP-Study, but the test material degrades under the test conditions and the test was conducted as a static test.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride

EC Number:

605-254-1

Cas Number:

16142-27-1

Molecular formula:

C6 H11 N4 O2 . Cl

IUPAC Name:

5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Sampling and analysis

Analytical monitoring:

yes

Test organisms

Test organisms (species):

other: Pseudokirchneriella subcapitata Hindák

Details on test organisms:

The test organism is Pseudokirchneriella subcapitata Hindák, strain SAG 61.81. The algae used in this study are purchased from the MBM Sciencebridge GmbH, Hans-Adolf-Krebs-Weg 1, D-37077 Göttingen, Germany.
The algae were grown semi-continuously in sterile cultures under permanent illumination in the laboratory. Old medium was periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state. Stock cultures were ordered regularly from the culture collection. Culture conditions were as follows:
• Illumination: from the top by light tubes, 60 – 120 µEm-2s-1 at cell culture level
• Temperature: 21 – 24 °C
• Culture flasks: 100 mL Erlenmeyer flasks
• Visually healthy cells were used for the test
• CO2 supply by shaking on a rotating shaker.

Cells from this semi-continuous liquid stock culture were used for the test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

pH:

7.5

Salinity:

AAP-Medium, Annex 3 of OECD 201

Details on test conditions:

Test procedure: Static
Duration: 3 days (72 hours)
Initial cell density: 0.5 × 104 cells/mL
Temperature: 22.9 – 23.3 °C
pH of control: 7.45 – 7.63
Illumination: continuously from the side, 79.1 µEm-2s-1
Culture flasks: 100 mL Erlenmeyer flasks with aluminium caps
CO2 supplied: By continously shaking

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

5.45 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

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:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

9.52 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

0.125 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 5

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

24.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 6

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

1.08 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 7

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

7.81 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 8

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

0.156 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 9

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

2.44 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 10

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

0.122 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50-value for growth rate (ErC50) was 24.7 mg/L (nominal) and 1.36 mg/L (actual). The EC50-value for yield (EyC50) was 9.29 mg/L (nominal) and 0.160 (actual).
The overall LOEC was determined to be at 7.81 mg/L (nominal) and at 0.215 mg/L (actual) and the overall NOEC was determined to be at 2.44 mg/L (nominal) and at 0.107 mg/L (actual).

Executive summary:

It has been shown during the test, that the substance is not stable under the test conditions. According to the ECHA Guidance on the Application of the CLP Criteria the L(E)C50, for classification purposes, may be calculated based on the geometric mean concentration of the start and end of test, if measured data are available for the start and end of test as it is in this test.

According to the ECHA Guidance the growth rate endpoint is preferred for the clasification purposes, because it is not dependent on the test design.

According to the ECHA guidance the ErC50 (Growth rate) of 1.36 mg/l was considered relevant for classification. Therefore the test substance is classified as toxic for the environment with longlasting effects.