Pseudoephedrine hydrochloride

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 in compliance with GLP-criteria.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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:

Pseudoephedrine hydrochloride

EC Number:

206-462-1

EC Name:

Pseudoephedrine hydrochloride

Cas Number:

345-78-8

Molecular formula:

C10H15NO.ClH

IUPAC Name:

2-(methylamino)-1-phenylpropan-1-ol hydrochloride

Details on test material:

- Name of test material (as cited in study report): (+)-Pseudoephedrin-Hydrochlorid
- Aggregate state/appearance: solid (crystalline0 / white
- Homogeneity: homogeneous
- Storage conditions: ambient (RT), light exclusion

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

At the start (after 0h) and the end (after 72h) of the test the uninoculated replicates were analyzed.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
The test substance was stirred in deionized water for about 20 min at approximately 20 ± 2 °C. The stock solution was clear and colourless. The nominal concentration of the stock solution was 125.3 mg/L. Following this, serial dilutions of this stock solution were prepared in order to obtain the desired test concentrations.

Test organisms

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

The test strain of Desmodesmus subspicatus CHODAT SAG 86.81 is obtained at regular intervals from SAG (Collection of algal cultures in Göttingen) and is kept in liquid culture in the Laboratory of Experimental Toxicology and Ecology.

PRECULTURE TECHNIQUES:
- Seed-culture: a seed culture was incubated for 4 days at 23 ± 2°C; final cell density: 1.92E+06 cells/mL
- Pre-cutture: seed-culture was taken to inoculate a pre-culture (initial cell density: 1E+04 cells/mL) . The pre-culture was incubated for 3 days at 23 ± 2°C. Final cell density : 4.4E+05 cells/mL.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

Test temperature:

23 ± 2 °C

pH:

7.9 - 8.2

Nominal and measured concentrations:

- Nominal test concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L (based on range finding test)
- Measured concentrations: The nominal concentrations of 0 and 100 mg/L were analysed at t=0 and at t= 72 h.
- t=0: n.d. and 99.0 mg/L
- t=72h: n.d. and 98.7 mg/L

Details on test conditions:

TEST SYSTEM:
- Test vessel: Erlenmeyer flasks (nominal volume 250 mL) plugged with gas permeable siliconsponge caps
- Fill volume: 100 mL
- Initial cells density: 1E+04 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3

TEST MEDIUM / WATER PARAMETERS:
- Source/preparation of dilution water: according to OECD guidelines

OTHER TEST CONDITIONS:
- Photoperiod: permanent illumination
- Illumination: artificial light, type universal white (OSRAM L 25)
- Light intensity: about 60 - 120µE/(m2·s) at a wave length of 400 - 700 nm

EFFECT PARAMETERS MEASURED:
- Measurement of fluorescence: after 0, 24, 48 and 72 h
- Determination of cell concentrations: counting chamber (Neubauer improved)
- Chlorophyll measurement: in vivo chlorophyll-a-fluorescence (pulsed excitation with light flashes having a wavelength of 435 nm)

Reference substance (positive control):

yes

Remarks:

Potassiumdichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

< 12.5 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.:

29.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

12.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 5

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

13.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 6

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

48.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Results with reference substance (positive control):

The72-h EbC50 (72 h) was 0.48 mg/L (date of the last control experiment: 25 Nov 2002).

Reported statistics and error estimates:

The EC values are calculated (linear regression analysis) from the concentration-response relationship. The Dunnett's test (one-sided) is carried out at a 95 % significance level.

Any other information on results incl. tables

Inhibition of growth rate:

Nominal conc. (mg/L)	Growth inhibition (%)
0 (control)	0.0
12.5	2.9
25	7.2
50	19.6
100	41.6