[No public or meaningful name is available]

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June-September 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Cas Number:

890707-29-6

Molecular formula:

C10H11N3O

IUPAC Name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Test material form:

solid: particulate/powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 120 mg/L
Analytical confirmation was performed at test initiation and termination.

Test solutions

Vehicle:

yes

Details on test solutions:

A 1200-mg sample of test item was weighed and mixed with 1 mL of N,N-dimethyl formamide. Approximately 1.5 litres of exposure medium was transferred to 2-litre beaker from the respective aquaria. The test item, mixed with N,N-dimethyl formamide, was transferred to the beaker containing exposure medium, sonicated for 30 minutes and transferred to the respective aquaria (i.e 120 mg/L).

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Commercial fish farm (recorded in full study report)
- Age at study initiation: Juvenile

ACCLIMATION
- Acclimation period: 7 days
- Type and amount of food during acclimation: Standard commercial fish food
- Feeding frequency during acclimation: Daily, the feeding was stopped 24-hour prior to the commencement of the experiment.
- Health during acclimation: No diseases or mortality were observed during the period

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

218 mg/L

Test temperature:

21.3 to 22.0°C

pH:

7.27-8.50

Dissolved oxygen:

7.88-9.14 mg/L

Conductivity:

794 μs/cm

Nominal and measured concentrations:

Nominal concentrations: 0 (control), solvent control (0.1 mL/L N,N-dimethyl formamide) and 120 mg/L test item.
Measured concentration: 114.57 mg/L test item.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria containing 10 L dilution water
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Well water and soft water (reverse osmosis water) mixture of 1:1 ratio. Well water analyzed biannually for chemical characteristics.
- Intervals of water quality measurement: Total hardness and conductivity were measured in the dilution water prior to test initiation. Temperature, dissolved oxygen concentration, and pH were measured daily in controls and test concentration.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 12 hours light and 12 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Observations for mortality and sublethal effects were made at 3 and 6 hours and once every 24 hours for the duration of the test.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: The nominal concentrations were 0 (control), solvent control (0.1 mL/L N,N-dimethyl formamide), 7.5, 15, 30, 60 and 120 mg/L test item
- Results used to determine the conditions for the definitive study: At the end of 96 hours, there was no mortality or sublethal effects observed in controls and all test item concentrations.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 114.57 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

No mortality or sublethal effects was observed during the study in control, solvent control, (0.1 ml/L N,N-dimethylformamide) and the 114.57 mg/L mean measured limit test concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LC50 value, based on the mean measured limit test
concentration of the substance and mortality, was greater than 114.57 mg/L.

Executive summary:

The acute toxicity of the test substance to the Freshwater Fish, Danio rerio, was determined in a 96-hour static test according to OECD Guideline 203.
The study was conducted as a limit test at a nominal concentration of 120 mg/ test substance. The study was conducted with a dilution water control and solvent control (0.1 mL/L N,N-dimethylformamide) at a temperature range of 21.3 to 22.0°C. Seven fish were used for the limit test concentration and controls. Exposure of fish to the mean measured limit test concentration of 114.57 mg/L resulted in 0% mortality at the end of 96 hours. The concentrations of the test substance were measured in 120 mg/L at 0 and 96 hours. The mean measured limit test concentration was 97.32% of the nominal concentration. No mortality or sublethal effects were observed in the dilution water control and solvent control groups.
The 96-hour LC50 for Danio rerio based on mortality and the mean measured limit test concentration was greater than 114.57 mg/L test substance.