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Ecotoxicological information

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:
1993-11-24 to 1994-10-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
EC 92/96
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Analytical purity: >= 99.65 %
Lot/batch No.: 93.166
Analytical monitoring:
yes
Details on sampling:
Each test medium will be sampled at the start and at the end of the test. Both the amount of test article incorporated into the algal biomass and the substance in solution will be taken into account. However, as determination of the test article concentration in the algal biomass may pose significant technical problems, concentration of the test article will be checked in the “non-inoculated treated” flask containing the highest test article concentration but without algae. All samples will be immediately deep-frozen and analysed later to determine actual concentrations.
Samples were thawed and filtered through Acrodisc LC 13 PVDF 0.45 µm syringe filter to remove any undissolved test article.
Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: Dimethylsulfoxide (DMSO - 50 mg/L)
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish - Brachydanio rerio;
- Strain: Hamilton-Buchanan;
- Source: Société d'Elevage Piscicole Contrôlé (La Grande Rivière 69490 Saint-Forgeux, France;
- Age at study initiation: not indicated;
- Length at study initiation: 3.0 +/- 0.5 cm;
- Weight at study initiation: not indicated;
- Method of breeding: not indicated;
- Feeding during test: No feeding is provided during the study;

ACCLIMATION
- Acclimation period: 7 days minimum before start of treatment;
- Acclimation conditions: same as test;
- Type and amount of food: dehydrated flakes;
- Feeding frequency: daily until at least 24 hours before start of treatment;
- Health during acclimation: less than 5 % mortality must be noted in the batch during the 7 day period preceeding the test;
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not indicated
Hardness:
90 mg CaCO3/L
Test temperature:
20 - 22 °C
pH:
6.4 - 7.0
Dissolved oxygen:
81 - 98 mg/L
Salinity:
NA
Nominal and measured concentrations:
Nominal concentrations: 0, 1, 10, 50, 100, 250 mg/L;
Measured concentrations: No test article could be detected, the actual concentration being lower than the limit of detection of the analytical method (1 µg/mL).
Details on test conditions:
Freshwater fish (Brachydanio rerio) were exposed to the test article for 96 hours at nominal concentrations of 1, 10, 50, 100 and 250 mg of test article per litre of test medium. Ten fish were used per treatment group, in comparison with an untreated control group and an auxiliary substance control group.
A static system was used, and each group of 10 fish was kept in 4 litres of test medium.
Dimethylsulfoxyde (DMSO - 50 mg/L) was used as auxiliary substance, to improve the solubility of the test article. Manual stirring was provided once or twice a day in the tanks during the study period.
Examination for mortality and behaviour abnormalities were performed after the first 2-4 hours, then 24, 48, 72, and 96 hours after the start of the test.
Measurements of pH, dissolved oxygen and temperature were performed at the start of the study for each test medium, then approximately 24, 48, 72 and 96 hours later.
Reference substance (positive control):
not specified
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 250 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.:
> 250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 250 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.:
250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
Mortality:
One death was noted at the 72 hours observation, which was not time nor dose related. It was considered to be accidental. No other mortality was noted.
Clinical observations:
Only some modifications of swimming behaviour were noted during the study period at the 100 and 250 mg/L concentrations: fish swimming in group at the bottom of the tank and fish agitated from the 48 hour observation onwards.
No abnormality was noted at the other concentrations.
Observation of test media:
Particles of the test article at the surface of water and deposit of test article on the walls of the tank were noted during the whole study. This was observed for the 10 mg/L to the 250 mg/L tanks and was proportional to the concentration.
Analysis of actual concentrations:
No test article could be detected in the actual concentration being lower than the limit of detection of the analytical method (1 µg/mL).
Quality criteria:
The quality criteria were respected for the study:
- no mortality was noted in the control and auxiliary control groups,
- the oxygen concentration was higher than 60 % of the air-saturation,
- despite no test article could be detected during analysis, any test article dissolved in the media was considered as stable because no other peak of possible degradation products appeared on the chromatograms.
Sublethal observations / clinical signs:

From the results obtained under the experimental conditions employed, the conclusion can be expressed as follows:

 

LC50, for Brachydanio rerio (nominal concentrations):

 

Time of exposure (hours)

LC50(mg/l)

Nominal concentration (mg/l)

24

higher than limit of solubility

up to 250

48

higher than limit of solubility

up to 250

72

higher than limit of solubility

up to 250

96

higher than limit of solubility

up to 250

 

LC0 (no observed effect concentration after 96 hours) : higher than the limit of solubility.

 

LC 100 (lowest concentration causing 100 % mortality after 96 hours) : higher than the limit of solubility

Validity criteria fulfilled:
yes
Conclusions:
HAT ISO was tested in a 96 hour static test for acute toxicity to fish. The LC50 for Brachydanio rerio was determined to be higher than the limit of solubility by nominal concentrations up to 250 mg/L. No classification and labelling is necessary according to Regulation 1272/2008/EC (CLP).
Executive summary:

HAT ISO was tested in a 96 hour static test for acute toxicity to fish.

Mortality:

One death was noted at the 72 hours observation, which was not time nor dose related. It was considered to be accidental. No other mortality was noted.

Clinical observations:

Only some modifications of swimming behaviour were noted during the study period at the 100 and 250 mg/L concentrations: fish swimming in group at the bottom of the tank and fish agitated from the 48 hour observation onwards. No abnormality was noted at the other concentrations.

Conclusions:

The LC50 of HAT ISO for Brachydanio rerio was determined to be higher than the limit of solubility by nominal concentrations up to 250 mg/L.

Description of key information

The LC50 of HAT ISO for Brachydanio rerio was determined to be higher than the limit of solubility by nominal concentrations up to 250 mg/L.

Key value for chemical safety assessment

Additional information

HAT ISO was tested in a 96 hour static test for acute toxicity to fish.

Mortality:

One death was noted at the 72 hours observation, which was not time nor dose related. It was considered to be accidental. No other mortality was noted.

Clinical observations:

Only some modifications of swimming behaviour were noted during the study period at the 100 and 250 mg/L concentrations: fish swimming in group at the bottom of the tank and fish agitated from the 48 hour observation onwards. No abnormality was noted at the other concentrations.

Conclusions:

The LC50 of HAT ISO for Brachydanio rerio was determined to be higher than the limit of solubility by nominal concentrations up to 250 mg/L.