Registration Dossier

Diss Factsheets

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 with acceptable restrictions.

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
Chemical structure
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:
- Test substance: (+)-Pseudoephedrine hydrochloride
- Physical state: solid

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION:
- 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)

HOUSING:
- Flow-through tank in tap water cleaned by active carbon and aerated with oil-free air.
- Photoperiod: 16 hours light and 8 hours dark
- Duration of housing and adaptation: about 2 months
- Water temperature: 19 - 22 °C
- Mortality during the last 2 weeks of housing: about 0.07%
- Mortality during the adaptation period: 0%
- Medical treatment: twice with 0.05 mg/L malachite green chloride; once with 10 mg/L tetracycline hydrochloride
- Type and amount of food: Growing Feed F/B 50, Ssniff Spezialdiaeten GmbH, Soest, Germany; ad libitum

ACCLIMATION:
- Adaptation to test water and test temperature: 3 days

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: 0 (control), 100, 215, 464 and 1000 mg/L
Details on test conditions:
TEST SYSTEM:
- Test vessel: all-glass aquarium (30 x 22 x 24 cm)
- Fill volume: 10L
- Aeration: Continuous (slight) aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

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
- Withdrawal of food: 1 day before and during exposure

EFFECT PARAMETERS MEASURED:
- Mortality and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 hours
Reference substance (positive control):
yes
Remarks:
Chloroacetamide

Results and discussion

Effect concentrations
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)
Details on results:
- Mortality: After 96 hours exposure 2/10 fish had died at a test concentration of 464 mg/L. All fish (10/10) had died at the highest tested concentration of 1000 mg/L. The 96-h LC50 was determined at > 464 and < 1000 mg/L.

- Other symptoms: 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.
Results with reference substance (positive control):
48-h LC50: ca. 31 mg/L (determined October 1988)
Reported statistics and error estimates:
Finney, D.J., Probit analysis, Cambr. Univ. press, 3rd ed., 1971. Certain aspects of this method were modified.

Applicant's summary and conclusion