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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

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 concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
220 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
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)
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

Applicant's summary and conclusion