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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24-28 January 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP and guideline study. No measured concentrations, insufficient data on composition and identity (no CoA included), phys-chem data (vapour pressure, solubility and stability) are lacking. Results can likely be reproduced. The substance seems tested at the maximum water solubility concentrations (undissolved material and cloudy test solutions) and still no mortality occurred. Conclusion seems therefore justified. No CoA included in the report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No analysis of test substance, no phys-chem data, number of fish higher than 1992 OECD version
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
see comments OECD guideline
Principles of method if other than guideline:
Stability of test substance was not determined analytically.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
Preparation of test solutions / dispersions:
After melting the total batch in a water bath separately for each concentration 0.5, 1.0, 50.0 and 100.0 g test substance were mixed each with 1 g Tween 80 (0.1 g/l) premixed with small quantities of aqua bidest. to prepare a dispersion and then transferred into the test water using an ultra-turrax stirrer. Analogously 1 g Tween 80 was added to a carrier control.

Subsequently the fish were placed into the aquaria within 5 min. after the test material was added.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Animal species: Zebra fish (Brachydanio rerio HAll. and BUCH.)
Consignment dated: Nov. 23. 1993
Supplier: West Aquarium GmbH Bad Lauterberg, Germany
Body length: 3.29 cm (range: 2.8 - 3.6)
Body weight: 0.305 g (range: 0.16 - 0.45)
Corpulence factor of the batch: 0.86 (determined Jan. 26, 1994). The corpulence factor K Is calculated from the weight W (g) and the length L (cm) measured from the tip of the mouth to the distal end of the caudal fin according to the formula K-100xW/L E3.
Age: about 5 months
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 and 8 hours dark
Duration of housing: about 2 months
Mortality during the last 2 weeks of housing: 0%
Medical treatment: none
Diet: "Tetra Min" standard feed for aquarium fish Tetra - Werke, Melle, Germany ad libitum and an workdays additionally live artemia
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
Total hardness about 2.5 mmol/l (- about 250 mg/l CaCO3)


pH . about 8.0
Test temperature:
Water temperature: 23 - 25 centigrade
pH:
pH: 8.0 - 8.6
Acid capacity abaut 5.5 mmol/l
Dissolved oxygen:
Oxygen content > 60% of maximum saturation
Nominal and measured concentrations:
Nominal concentrations: 50 - 100 - 5000 - 10000 mg/L, incl control and carrier control
Details on test conditions:
Photoperiod: 16 hours light and 8 hours darkness
Volume of water: 10 liters (water depth about 17 cm)
No. of animais per test vessel: 10
Loading (g fish /L test water): 0.3
Test vesseis: all-glass aquaria (30 cm x 22 cm x 24 cm), one aquarium for each concentration
Test temperature: 23 centigrade (temperature-controlled room)
Adaptation: Test conditions corresponded to housing conditions.
Test period: Jan. 24 - Jan. 28. 1994
Withdrawal of food: 1 day before and during exposure
Aeration: slight
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: at maximum water solubility the substance does not cause mortality under the conditions of the test
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Remarks:
: apathy
Details on results:
In the highest concentration (10000 mg/L), some apathy was observed after 4h exposure.
All test solutions containing test substance were cloudy and undissolved test substance was visible at the water surface.
No mortality.
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
Finney, 1971, probit analysis if possible.
Sublethal observations / clinical signs:

No mortality in any of the test or control vessels.

Validity criteria fulfilled:
yes
Conclusions:
Study GLP and according to guideline. Limited data on composition and phys-chem data (vapour pressure, solubility and stability). The concentrations of the testsubstance have not been confirmed. Substance seems tested at maximum water solubility (undissolved material and cloudy test solutions). Based on nominal concentrations the conclusion is correct, but could be re-phrased into "at maximum water solubility the substance does not cause mortality under the conditions of the test". Study is repeatable.
Executive summary:

The purpose of this study was to determine the acute toxicity of Basoplast 20 konz on the Zebra fish (Brachydanio rerio HAM. and BUCH). Zebra fish were exposed over a 96-hour period to a range of 4 concentrations: 50, 100, 5000 and 10 000 mg/l.

An untreated control and a carrier control were included. The study was performed using a static procedure. The study procedure was based on the OECD guideline 203 (1984). The results were: LC50 after 96 hours > 10000 (mg/L) (1% significance level). Non-lethal observed toxicity symptom was apathy only in the highest concentration at 4h. No observed effect concentration (NOEC): 5000 mg/l, the maximum concentration tested causing no mortality was 10 000 mg/L, all based on nominal concentrations.

Description of key information

Key study is BASF Aktiengesellshaft (1995). OECD203, zebra fish Brachydanio rerio, 96h, static test. Study considered reliable with restrictions. End-point based on nominal concentration. LC50 greater than highest concentration tested (> 10000 mg/L), but in fact concerns maximum water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
10 000 mg/L

Additional information

The substance seems tested at the maximum water solubility concentrations (undissolved material and cloudy test solutions) and still no mortality occurred. Even if measured concentrations, data on composition and identity, phys-chem data (vapour pressure, solubility and stability) are lacking, the key study is a GLP and guideline study and the test results can likely be reproduced.