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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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
Reference substance name:
Pseudoephedrine hydrochloride
EC Number:
206-462-1
EC Name:
Pseudoephedrine hydrochloride
Cas Number:
345-78-8
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