Pseudoephedrine

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study. Missing analytical investigation of the test substance during and after the experiment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DIN 38412, part L15

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(+)-Pseudoephedrin-HCl

IUPAC Name:

(+)-Pseudoephedrin-HCl

Details on test material:

IUCLID4 Test substance: other TS: (+)-Pseudoephedrine hydrochloride
- Lot/batch No.: 19117
- Analytical purity: 99-100.5 %

Sampling and analysis

Analytical monitoring:

not specified

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was added to the test water without any pretreatment

Test organisms

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, Hohenwestedt, Germany
- Age at study initiation (mean and range, SD): 3 days
- Length at study initiation (length definition, mean, range and SD): 7.0 cm (range: 6.0 - 8.5 cm)
- Weight at study initiation (mean and range, SD): 4.4 g (range: 2.8 - 7.1 g)


ACCLIMATION
- Type and amount of food: Growing Feed F/B 50, Ssniff Spezialdiaeten GmbH, Soest, Germany; ad libitum
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no mortality observed

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

2.5 mmol/l

Test temperature:

20 °C

pH:

7.3 - 7.6

Dissolved oxygen:

7.9 - 8.4 mg/l

Nominal and measured concentrations:

Nominal test substance concentrations:
100, 215, 464 and 1000 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquarium (30 x 22 x 24 cm)
- Fill volume: 10 l
- Aeration: silight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38 412, part 11


OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Results used to determine the conditions for the definitive study: LC50 after 96 h: 100 - 1000 mg/l

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

220 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 460 - 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

After 4 hours exposure tumbling was observed at a test substance concentrations of 1000 mg/l . At 464 mg/l tumbling was observed after 24 hours.

Reported statistics and error estimates:

FINNEY, D .J ., PROBIT ANALYSIS, CAMBR . UNIV . PRESS, 3RD ED ., 1971