[No public or meaningful name is available]

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 16 2020 to December 18 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

copper(II) 3,3',3'',3'''-(29H,31H-phthalocyanine-2(or 3),9(or 10),16(or 17),23(or 24)-tetrayltetrasulfonyl)tetrapropane-1-sulfonate and its amides with (2-hydroxypropyl)amine, sodium salts

Molecular formula:

Cannot be adequately assigned

IUPAC Name:

copper(II) 3,3',3'',3'''-(29H,31H-phthalocyanine-2(or 3),9(or 10),16(or 17),23(or 24)-tetrayltetrasulfonyl)tetrapropane-1-sulfonate and its amides with (2-hydroxypropyl)amine, sodium salts

Test material form:

solid: particulate/powder

Details on test material:

Molecular formula: C50H52CuN10Na2O20S8 (main component)
Molecular weight: 1479.02 (main component)
Purity of test item: 93.1%
Impurity
Water: 6.5%
EDTA-4Na: 0.4%
Supplier: FUJIFILM Corporation
Lot number: M-002P
Storage conditions: Store in the dark at room temperature.

Specific details on test material used for the study:

Not specified

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The test solutions were collected at the start and end of the exposure period.
The collected test solutions (the analytical sample) were used as the high-performance liquid
chromatography (HPLC) analytical samples without treatment or after appropriate dilution with dechlorinated tap water.

Test solutions

Vehicle:

yes

Details on test solutions:

The test sample (50.0 mg) was precisely weighed by an electronic analytical balance. It
was dissolved and filled up to 50 mL with ultrapure water to obtain 931 mg/L solution of
the test item (operated by study No.: 99428). The solution was diluted with dechlorinated
tap water to prepare 46.6 mg/L standard solution.
The concentration of the test item in each HPLC analytical sample was determined on
the basis of a comparison of the peak area on the chromatogram of the HPLC analytical
sample with that of a standard solution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna Clone A
Reason for selection of species: Species recommended in the test guideline
Supplier: The University of Sheffield, UK
Date of supply: July 9, 1990
Acclimation: Young daphnids produced by parents that were cultured in this test facility were used. The parents to obtain young daphnids were bred in the same quality of water (dechlorinated tap water), water temperature (20±1 °C) and photoperiod (16-hour light/8-hour dark) as used in the study. The parent animals used for the test were same lot and their age and survival rate were 20-day old and 100%, respectively. Chlorella vulgaris of 0.1-0.2 mgC (Organic carbon content)/day per Daphnia was fed to the parents once a day.

Selection of young daphnia: Less than 24-hour-old daphnids
Allocation: Random sampling
Confirmation of reproducibility of test system: A 48-hour acute immobilization study of a reference substance with the test organisms was periodically conducted.

Study design

Test type:

static

Water media type:

not specified

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

As required by study guideline.

Post exposure observation period:

Not specified

Test conditions

Hardness:

14 CaCo3 mg/L

Test temperature:

19.9-20.0°C

pH:

7.9-8.0

Dissolved oxygen:

8.3-8.6 mg/L

Conductivity:

7.4 mS/m at 25 °C

Nominal and measured concentrations:

Nominal concentration was 99.8 mg/L and measured concentration was 101 mg/L.

Details on test conditions:

Type of test: Static regime (no renewal of test solution)
Exposure duration: 48 hours
Test concentration : 100 mg /L (upper limit concentration of test guideline) as limit test
The test concentration was decided from the results of the preliminary study.
Control: Dilution water without the test item
Replicate: 4 replicates/test level
Number of organism: 20 daphnids/test level (5 daphnids/test vessel)
Volume of test solution: 400 mL/test level (1 00 mL/test vessel)
Temperature of test solution: 20±1°C
Dissolved oxygen concentration: ≥ 3 mg/L without aeration
pH adjustment: No adjustment
Lighting condition: Room light, 16-hour light/8-hour dark
Feeding: No feeding

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 ng/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both> 100 mg/L.

Results with reference substance (positive control):

Not specified

Reported statistics and error estimates:

Not specified

Any other information on results incl. tables

In the exposure level, neither immobilization nor abnormalities of behavior or appearance were observed.

In the control, no abnormal response (discolor of body, trapping at the surface of the water and so on) was observed during exposure, which met the criterion for the validity of the test (i.e. not more than 10%).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both> 100 mg/L.

Executive summary:

A 48-hour acute immobilisation study in Daphnia magna was carried out in accordance with OECD test guideline 202, in compliance with GLP.  This study was conducted as a limit test in order to confirm the effect of the test item on the test organisms at the upper limit concentration of the test guideline. As a result, no adverse effect were found in the definitive study. Therefore, it was determined that the test item had no adverse acute effect on the test organisms at the upper limit concentration of the test guideline.
The concentrations of the test item in the test solution during exposure were kept within the range of 80-120% of the nominal concentration. The environmental conditions were within the suitable range. Therefore, it is concluded that this study complied with the applied test guidelines.

The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both > 100 mg/L.