Cuprate(4-), [[3,3',3'',3'''-[(29H,31H-phthalocyanine-1,8,15,22-tetrayl-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32)tetrakis(sulfonyl)]tetrakis[1-propanesulfonato]](6-)]-, sodium (1:4), (SP-4-1)-

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Remarks:

existing study required to satisfy regulatory requirements in worldwide regulatory regions

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study test phase 2014-01-14 to 2014-01-22.

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:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine

EC Number:

696-145-8

Cas Number:

944730-39-6

Molecular formula:

C44H36CuN8O20S8 .4Na

IUPAC Name:

tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Water samples were taken from the control and the 120 mg/L test vessel at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) for quantitative analysis. The samples were stored frozen prior to analysis.

Test solutions

Vehicle:

no

Details on test solutions:

A nominal amount of test item (2400 mg) was dissolved in 20 liters of test water to give the 120 mg/L test concentration. The test media was stirred using a flat-bladed mixer for approximately 1 minute to ensure dissolution.

The 120 mg/L test group was observed to be a dark blue solution for the duration of the test.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in house since 17 December 2013. Fish were maintained in a glass fiber tank with a "single pass" water renewal system. Fish were acclimatized to test conditions from 02 January 2014 to 14 January 2014. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.

The water temperature was controlled at 14 ºC with a dissolved oxygen content of greater than or equal to 10.0 mg O2/L. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test. There was 1 mortality in the 7 days prior to the start of the test and the fish had a mean standard length of 4.4 cm (sd = 0.3) and a mean weight of 1.12 g (sd = 0.23) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.39 g bodyweight/liter.

The diet and diluent water are considered not to contain any contaminant that would affect the integrity and outcome of the study.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation. The fish were removed from the 120 mg/L test group at 1, 6, 24, 48, 72 and 96 hours after the start of exposure in fresh diluent to facilitate observations due to the opacity of the media.

Test conditions

Test temperature:

14ºC

pH:

7.0-8.2

Dissolved oxygen:

9.4-11.0 mb o2/L

Nominal and measured concentrations:

Analysis of the 120 mg/L test preparation at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

3 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:

6 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

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 4

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 5

Duration:

72 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:

96 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:

There were no sub-lethal effects of exposure observed in the test.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC50 of greater than 120 mg/L. The No Observed Effect Concentration was 120 mg/L.

Executive summary:

Introduction

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Results and Conclusions

Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave LC₅₀values of greater than 120 mg/L. The No Observed Effect Concentration was 120 mg/L.