Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1988-01-11 - 1988-01-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: German industrial standard test guideline DIN 38 412, part L15.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SULFOPHTHALSAEURE-2,4-NEUTRALSALZ
- Analytical purity: ca. 67% ; 33% sodium sulphate
- Substance type:

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The doses were chosen based on a range finding study.
- the product was added to the test water without any pretreatment

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus idus (golden variety)
- Source: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation: 6.2 cm (range: 5.7-6.9)
- Weight at study initiation: 2.7 g (range: 2.2-3.4)
- Feeding during test: no
- Frequency: Withdrawal of food before exposure: 1 day

ACCLIMATION
- Acclimation conditions (same as test or not): oil-free aerated and charcoal filtered tap water, flow-through system
Water temperature: 20-21°C
Acclimation to test water and test temperature: 3 days

- Type and amount of food: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Feeding frequency: ad libitum.

HOUSING
- Housing water: charcoal filtered dechlorinated water in continuous flow-through
- Aeration: oilfree air
- Light regime: 16 : 8 hours light : dark
- Hardness: 2.5 mM
- Oxygen concentration: > 60 % of maximum saturation
- pH: about 8.0
- Water temperature: 20 - 22 °C
- Duration of housing: about 1 month
- Medical treatment: Once with 0.05 mg/L Malachitegreen and once with 10 mg/L tetracyclinhydrochlorid (CHECK!)
- Feeding: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Amount of feed: ad libitum
- Mortality during the last 2 weeks of housing: 0.2 %

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h

Test conditions

Hardness:
Total hardness: 2.5 mmol/L
Test temperature:
20 ±1 °C
pH:
8.0 ± 0.3
Dissolved oxygen:
7.3 - 8.4 mg/L
Nominal and measured concentrations:
Nominal concentrations: 5000 mg/L, 10000 mg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: aquaria open
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: 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: 2.7 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
- Intervals of water quality measurement: 1, 24, 48, 72, and 96 hours

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms

Reference substance (positive control):
yes
Remarks:
Chloracetamid

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none


Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: ca. 31 mg/L (48 h)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes