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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:
16 to 20 August 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
The deviation was not considered to affect the integrity of the study or the validity
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
The test substance was received at Brixham Environmental Laboratory on 19 May 2004 and assigned the Brixham test substance number 04-0169. The test substance (Batch No SP04027 /GLP) was supplied as a white to cream solid.

The sample was stored at ambient temperature, in the container in which it was received until required for testing, when an appropriate subsample was provided for the test operator.
Analytical monitoring:
yes
Vehicle:
not specified
Details on test solutions:
This study was run with a nominal ceftazidime dihydrochloride concentration of 120 mg L1 together with a dilution water control.

The test solution was prepared by the addition of a known amount of ceftazidime dihydrochloride directly to 20 litres of dilution water in the test vessel. The resultant solution was clear and colourless.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
The test organism was the rainbow trout iOncorhynchus mykiss). The fish (batch 23/04) were obtained from Houghton Springs Fish Farm, Winterboume Houghton, Blandford Forum, Dorset DTJ 1 OPD on 2 July 2004 and held in stock tanks at Brixham Environmental Laboratory for at least 12 days before the start of the test. The last medication given to the fish was 37% Formaldehyde at a level of 200 mg L-1. The treatment was completed on 19 July 2004, >7 days prior to the test. There was less than 1 % mortalities observed in the batch of fish in the 7 days prior to the test. The fish were acclimatised to the test temperature ( 15 ± 1 °C) for a minimum period of 7 days. During the holding and acclimatisation periods the fish were fed appropriate amounts of a commercial fish food. Food was withheld from the fish for at least 24 hours prior to the commencement of the test. At the end of the exposure period, the fish from the dilution water control were weighed and measured. The range in weight was 1.56 to 2.49 g with a mean of 1.97 g, and the range in length was 48 to 55 mm with a mean of 51 mm. The loading of fish in the dilution water control was 0.69 g L-1.
Test type:
static
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
The total hardness of the dilution water was 46.7 mg L-1 CaC03
Test temperature:
15 ± 1 °C
pH:
5.3 to 7.7
Dissolved oxygen:
8.47 to 9.98 mg L-1
Salinity:
1.0 %
Conductivity:
The conductivity of the water was 226 µS cm-1.
Nominal and measured concentrations:
nominal concentration of 120 mg L-1
Details on test conditions:
The test procedure used was a static system. Single borosilicate glass vessels ( external dimensions; 400 mm x 280 mm x 280 mm; length x width x height) were used for the
Reference substance (positive control):
not specified
Key result
Duration:
3 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: the highest tested concentration in which there were no observed effects on the fish within the period of the test
Details on results:
Results can be found in the attachment of the background section.

Analytical Data
The highest limit of quantification of ceftazidime dihydrochloride in this study was 0.0056 mg L-1. All analytical values are quoted to two significant figures and percentages to the nearest integer. The overall mean measured concentration was 100% of the nominal value. The nominal concentration of ceftazidime dihydrochloride was used for the reporting of the results .

Biological data
The LC50 is defined as the concentration, calculated from the data obtained, resulting in the death of 5 0% of the fish in the time period specified. The results obtained were:
Time LC50
24 hour >120 mg L-1
48 hour >120 mg L-1
72 hour >120 mg L-1
96 hour >120 mg L-1

The no observed effect concentration (NOEC) is defined as the highest tested concentration in which there were no observed effects on the fish within the period of the test.

No mortalities or symptoms of toxicity were observed in the fish in the dilution water control or the single test concentration of 120 mg L-1 (nominal), therefore
96 hour NOEC = 120 mg L-1

Physical and chemical data
The dissolved oxygen concentrations in the test vessels ranged from 8.47 to 9.98 mg L-1, pH values ranged from 5.3 to 7.7, and the temperatures recorded were within the range 15 ± 1 °C. At no time during the course of the study was dissolved oxygen concentration in any of the test vessels less than 60% of the air-saturation value. The continuous record of temperature, recorded automatically, in the dilution water control during the study remained within 15 ± 1 °C.

The total hardness of the dilution water was 46.7 mg r1 CaC03, and the conductivity of the water was 226 µS cm-1 @ 25°C.
Validity criteria fulfilled:
yes
Conclusions:
96 hour NOEC = 120 mg L-1
Executive summary:

Subject: Acute toxicity to rainbow trout (Oncorhynchus mykiss)

Guideline: OECD guideline 203, Fish, Acute Toxicity Test

Test species: Rainbow trout Oncorhynchus mykiss, Batch Ref 23/04

Source of organisms: Houghton Springs Fish Farm, Dorset DTI 1 OPD

Test concentrations: Dilution water control and nominal concentration of 120 mg L-1

Length of test: 96 hours, static, gentle aeration

Nominal test temperature: 15 ± 1 °C

Weight and length of dilution water control fish at end of exposure period

Weight: range 1.56 - 2.49 g, mean 1.97 g

Length: range 48 - 55 mm, mean 51 mm

Results based on nominal concentration of Ceftazidime dihydrochloride:

Time                                   LC50

3 hour                             >120 mg l-1

24 hour                           >120 mg l-1

48 hour                           >120 mg l-1

72 hour                           >120 mg l-1

96 hour                           >120 mg l-1

The NOEC (no observed effect concentration) is defined as the highest tested concentration in which there were no observed effects on the fish within the period of the test

96 hour NOEC = 120 mg l-1

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
120 mg/L

Marine water fish

Marine water fish
Effect concentration:
120 mg/L

Additional information

The LC50 was >120mg/L which was the highest nominal value tested