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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: German national standard DIN 38 412, part L15
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Ephedrine hydrochloride
EC Number:
200-074-6
EC Name:
Ephedrine hydrochloride
Cas Number:
50-98-6
IUPAC Name:
2-(methylamino)-1-phenylpropan-1-ol hydrochloride
Details on test material:
- Name of test material (as cited in study report): (-)-EPHEDRIN-HYDROCHLORID, PULVER
- Physical state: solid

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria.

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus L. (golden variety)
- Source: Fish farm Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation: 6.7 cm (range 5.7 - 7.2 cm)
- Weight at study initiation: 2.9 g (range 1.5- 4.4 g)
- Feeding during test: no, withdrawal of food 1 day before exposure.

ACCLIMATION
- Acclimation period: 1 month
- Acclimation conditions: oil-free aerated and charcoal filtered tap water, flow-through system
- Water temperature: 20 °C
- Duration of housing: 1 month
- Acclimation to test water and test temperature: 3 days
- Type and amount of food: : Growing feed F/B 50,
- Feeding frequency: ad libitum.
- Mortality during the last 2 weeks of housing: 1.2 %
- Mortality during the acclimation period: 0 %
- Medical treatment: twice with 0.05 mg/L malachite green chloride, once with 10 mg/L tetracycline hydrochloride

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:
21 °C
pH:
7.3 - 7.7
Dissolved oxygen:
7.4 - 8.6 mg/L
Nominal and measured concentrations:
Nominal concentrations: 0 (control) 100, 215, 464, 1000 and 1000 mg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass aquaria, open, 30 x 22 x 24 cm
- Volume of water: 10 liters
- Aeration: 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
- Biomass loading rate: 2.9 g fish /L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/Mg ratio: 4 : 1

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark
- Aeration: continuous aeration with oil-free air
- Withdrawel of food: 1 day before and during exposure

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Mortality: at 1, 24, 48, 72, and 96 hours
- Symptoms: apathy, abdominal distension, exophtalmos, escape reflex, hyperreflexia, convulsions, gasping, narcotic-like state, tumbling, restlessness, discoloration, headstand and accelerated respiration at 1, 24, 48, 72, and 96 hours

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: range-fiding test: 10, 100, 1000 and 10000 mg/L
- Results used to determine the conditions for the definitive study: LC50 after 96 h between 100 and 1000 mg/L
Reference substance (positive control):
yes
Remarks:
Chloroacetamide

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 464 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: tumbling
- Effect concentrations exceeding solubility of substance in test medium: no
- Other: Mortality was not reduced after neutralisation of the test solution at 1000 mg/L. Mortality was 100% after 96 h in the pH-adjusted and the not pH adjusted test solutions at 1000 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- LC50: 32 mg/L after 48 h
Reported statistics and error estimates:
Finney, D.J., Probit analysis, Cambr. univ. press, 3rd ed., 1971. Certain aspects of this method have been modified. The exact procedure can be seen from the standard operating procedures of the laboratory.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Cumulative mortality

Nominal conc. (mg/L)

Number of fish

Mortality (cumulated) after

1 h

24 h

48 h

72 h

96 h

0

10

0

0

0

0

0

100

10

0

0

0

0

0

215

10

0

0

0

0

0

464

10

0

0

4

4

4

1000

10

0

10

10

10

10

Applicant's summary and conclusion