Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992-07-20 to 1992-07-24
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
actual concentrations were not measured. - range of fish length is greater as recommended on the test guideline - conductivity of water was not stated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
adopted 1984-04-04
Deviations:
yes
Remarks:
, please refer to the field "Rationale for reliability incl. deficiencies" above.
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1984
Deviations:
yes
Remarks:
, please refer to the field "Rationale for reliability incl. deficiencies" above.
GLP compliance:
yes
Remarks:
exception: no stability control in the test medium was performed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sicocer F Eisenrosa 2320
- Physical state: solid, pink powder

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
no data

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method:
The product was added to the test water separately for each concentration by mixing with 1 g Tween 80 (0.1 g/L of test water); subsequently aqua bidest. was added in small quantities and then this mixture was transferred into the test water using an ultra-turrax stirrer. Analogously 0.1 g Tween 80/L test water was added to a carrier control. Subsequently the fish were placed into the aquaria.
- Controls: blank and solvent control
- Chemical name of vehicle: Tween 80
- Concentration of vehicle in test medium: 1 g Tween 80 (0.1 g/L of test water)

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium GmbH, D- W3422 Bad Lauterberg, FRG
- Length: 2.96 cm (range: 2.5 - 3.6)
- Weight: 0.23 g (range: 0.09 - 0.34)
- Corpulence factor of the batch: 0.89

Housing:
The fish were kept in a flow-through tank in tap water, not chlorinated, passed through an active carbon filter and aerated with oil-free air.
- photoperiod: 16 hours light/ 8 hours dark
- total hardness: about 2.5 mmol/L
- acid capacity: about 5.5 mmol/L
- oxygen content: >60% of maximum saturation
- pH: about 8.0
- duration of housing: about 2 months
- water temperature: 21 -25 °C
- mortality during the last 2 weeks of housing: 0%
- medical treatment: none
- diet: "Tetra Min" standard feed for aquarium fish, ad libitum and on workdays additionally live and frozen artemia

- Withdrawal of food: 1 day before and during exposure

ACCLIMATION
- Acclimation conditions: test conditions corresponded to housing conditions

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
about 2.5 mmol/L
Test temperature:
21 - 22°C
pH:
- test start (1 hour; blank control): 8.5
- test start (1 hour; solvent control): 8.5
- test start (1 hour; 100 mg/L): 8.7
- test start (1 hour; 1000 mg/L): 8.4
- test start (1 hour; 10000 mg/L): 8.1
- test end (96 hours; blank control): 8.5
- test end (96 hours; solvent control): 8.5
- test end (96 hours; 100 mg/L): 8.4
- test start (1 hour; 1000 mg/L): 8.6
- test end (96 hours; 10000 mg/L): 8.5
Dissolved oxygen:
- test start (1 hour; blank control): 8.6 mg/L
- test start (1 hour; solvent control): 8.5 mg/L
- test start (1 hour; 100 mg/L): 8.6 mg/L
- test start (1 hour; 1000 mg/L): 8.6 mg/L
- test start (1 hour; 10000 mg/L): 8.4 mg/L
- test end (96 hours; blank control): 7.5 mg/L
- test end (96 hours; solvent control): 8.1 mg/L
- test end (96 hours; 100 mg/L): 7.5 mg/L
- test start (96 hours; 1000 mg/L): 7.5 mg/L
- test end (96 hours; 10000 mg/L): 7.8 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
Nominal concentration: 100, 1000 and 10000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass aquarium (30 cm X 22 cm X 24 cm)
- Aeration: slight
- No. of organisms per vessel: 10 fish
- One vessel per concentration/control
- Loading (g fish / L test water): 0.23

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: municipal water of the city of Frankenthal, not chlorinated and passed through an active carbon filter.
- total hardness: about 2.5 mmol/L
- acid capacity: about 5.5 mmol/L
- Ca content: about 90 mg/L
- Mg content: about 10 mg/L
- pH: about 7.5

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours darkness

EFFECT PARAMETERS MEASURED:
- Determination of mortality and symptoms

TEST CONCENTRATIONS
- Range finding study
Based on the results of 2 range finding studies using tap water and the carrier Tween 80 (slight mortality (1/10) and no toxic signs at the concentrations 1000 and 10000 mg/L) the concentration 100 mg/L was selected. For classification of hazards to water the concentration 10000 mg/L was tested in parallel.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1% significance level
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- aquarium contents were coloured and cloudy. Sedimentary test substance was visible about 24 hours after the beginning.
- no mortality occurred.
- no symptoms were detectable.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
Determination or calculation of the median lethal concentration (LC50) using the probit analysis* after hours (nominal conc.): 1, 4, 24, 48, 72, and 96 hours.

*Reference:
Finney, D.J., Probit analysis, Cambr. Univ. Press, 3rd Ed., 1971
(certain aspects of this method have been modified)

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
LC50 (96 hours) > 10000 mg/L
NOEC: 10000 mg/L
No mortality or symptoms were observed during testing.