5,5'-{ethane-1,2-diylbis[thio-1,3,4-thiadiazole-5,2-diyldiazene-2,1-diyl(5-amino-3-tert-butyl-1H-pyrazole-4,1-diyl)]}diisophthalic acid

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:

Experimental phase 04 - 08 November 2013. Report issued: 18 December 2013.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetra potassium 5,5'-[ethane-1,2-diylbis[thio-1,3,4-thiadiazole-5,2-diyldiazene-2,1-diyl(5-amino-3-tert-buyl-1H-pyrazole-4,1-diyl)]}diisophthalate

EC Number:

700-616-6

Cas Number:

849608-59-9

Molecular formula:

C36H32K4N14O8S4

IUPAC Name:

Tetra potassium 5,5'-[ethane-1,2-diylbis[thio-1,3,4-thiadiazole-5,2-diyldiazene-2,1-diyl(5-amino-3-tert-buyl-1H-pyrazole-4,1-diyl)]}diisophthalate

Test material form:

solid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 120 mg/L of test material and control (0 mg/L of test material)
- Sampling method: The concentration of the test material was measured at 0 and 48 hours in the freshly prepared solutions and at 48 and 96 hours from the old solutions using HPLC.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Required amount of test material was weighed directly into a vial. The content of the vial was then added to the dilution water in the test tank. Both the control (consisting of dilution water only) and exposure solution were then stirred, using an overhead stirrer for 15 min.

- Evidence of undissolved material: The dilution water was clear and colourless whilst the exposure concentration was yellow/brown in colour, slightly cloudy with bubbles on top of the water column.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Strain: batch 134-13
- Source: Zeals fish farm, Warminster, Wiltshire, BA12 6LW
- Length at end of study: 37-45 mm, mean 40 mm.
- Weight at end of study: 1.23-2.43 g, mean 1.77g.
- Feeding during test: none
- Food type: Commercial fish food
- Frequency: Daily prior to testing (food was witheld from the fish at least 24h prior to commencement of the test.)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

47.0 mg/L (CaCO3) total water hardness of the dechlorinated water supply at the start of the study.

Test temperature:

22.2-22.8 C

pH:

7.91-7.74

Dissolved oxygen:

7.91-8.57 mg/L (91-98% air saturation)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass tanks
- Test vessel working volume: 30L
- Aeration: yes. gentle.
- Type of flow-through: semi-static with test solutions replaced after 48h.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Loading of fish in dilution water control approx. 0.59 mg/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Town's water which had been coarsely filtered to remove particulate material, passed through activated carbon and dechlorinated using sodium thiosulphate, Salts were added, as required, to maintain minimum hardness levels, and the treated water passed through an UV steriliser and filtered to 10 um. Supply was then delivered to a temperature controlled header tank in the test laboratory which was to the nominal test temperature of 22 +/- 1 C.
- Total organic carbon: 6.0 mg/L
- Particulate matter:<3 mg/L (ss at 105 C)
- Chlorine: <2 ug/L (free) <2 ug/L (total)
- Alkalinity: 23.2 mg/L (as CaCO3)
- Conductivity: 226 uS/cm


OTHER TEST CONDITIONS
- Photoperiod: 16h light and 8h dark with 20 min dawn/dusk transition.

EFFECT PARAMETERS MEASURED: Observations for mortalities and symptoms of toxicity were made at 3, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Test concentrations: Limit test of 120 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: No mortalities

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No mortalities were observed in the control or the 120 mg/L test concentration during this study. Therefore the 96h LC50 was determined to be >120 mg/L. It is concluded that 120 mg/L of the test material did not have a significant toxic effect on the test organism, Cyprinus carpio, in this study.

Executive summary:

Introduction

This study was performed to assess the acute toxicity of the test material to carp (Cyprinus carpio). The test method was designed to be compatible with:

OECD 203, Fish, Acute Toxicity Test. Adopted 17 July 1992.

Results and Conclusions

No mortalities were observed in the control or the 120 mg/L test concentration during this study. Therefore the 96h LC50 was determined to be >120 mg/L. It is concluded that 120 mg/L of the test material did not have a significant toxic effect on the test organism, Cyprinus carpio, in this study.