Pseudoephedrine hydrochloride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate

EC Number:

231-243-2

EC Name:

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate

Cas Number:

7460-12-0

IUPAC Name:

7460-12-0

Details on test material:

- Name of test material (as cited in study report): (+) Pseudoephedrine sulfate
- Aggregate state: solid
- Colour: white
- Instability against: light, oxigene, acid, alcali
- Special storage conditions : under N2, light exclusion, ambient

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

At the start of the test (after 0 h) and at the end of the test (after 48 h) samples from vessels without daphnids were analysed.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
The test substance was stirred in M4 medium for about 10 minutes at 20 ± 2°C. The nominal concentration of the stock solution was 100 mg/L . The test solutions were prepared by diluting the stock solution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

- Strain: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory Experimental Toxicology and Ecology of BASF AG in Ludwigshafen.
- Age of the animals at the start of the test: 2- 24h (starting with the 3rd breed of parent animals)
- Age of stock animals: 2 - 4 weeks

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

2.20 - 3.20 mmol/L

Test temperature:

19.5 - 20.2 °C

pH:

8.0 - 8.1

Dissolved oxygen:

8.7 - 8.8 mg/L

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 6.25, 12.5, 25, 50 and 100 mg/L (based on a range finding test)
- Measured concentrations: nominal concentrations of 0, 6.25 and 100 mg/L were analysed at t=0 and at t= 48 h.
- t=0: n.d., 6.54 and 101.2 mg/L
- t=24h: n.d., 7.33 and 102.4 mg/L

Details on test conditions:

TEST SYSTEM:
- Test vessel: flat bottom glass tubes (20 mL)
- Fill volume: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS:
- Source/preparation of dilution water: A synthetic fresh water was used for culture and test purposes . This water was prepared on the basis of an ultrapure, demineralized water with a conductivity <0.05 {µS/cm. For the composition of this M4 medium see ISO 10706. After preparation the M4 medium is aerated for approximately 24 h until saturation with oxygen is reached.

OTHER TEST CONDITIONS:
- Feeding: none
- Photoperiod: 16:8 h day-night regime
- Illumination: Artificial light, type warm white (e .g. OSRAM L58 W31)
- Light intensity: about 2- 7 µE/(m²s) at a wave length of 400 - 700 nm

EFFECT PARAMETERS MEASURED:
- Visual determination of mobility after 0, 24 and 48 hours

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

58.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95%C.L.: 48.7-70.7 mg/L

Results with reference substance (positive control):

24-h EC50: 0.84 mg/L (Date of the last control experiment: 13 Apr 2000).

Reported statistics and error estimates:

The test results allowed no statistical evaluation of the data (24h). For the statistical calculation of the EC5O the moving average method was used (48h) .

Any other information on results incl. tables

Number of mobile Daphnids in the different test concentrations:

Nominal conc. (mg/L)	Number of mobile daphnids after		Immobility at t=48h (%)
	24h	48h
0 (control)	20	20	0
6.25	20	20	0
12.5	20	20	0
25	19	17	15
50	18	13	35
100	19	0	100