Copper, [29H,31H-phthalocyaninato(2-)-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32]-, sulfonated, sodium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5 October 2020 to 26 October 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted April 13, 2004

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerated (2 – 8°C), protected from light
- Stability during storage: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor.

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/l and control
- Sampling method:
At the start of the media renewal (0 and 24-hours), 10 mL new media samples were taken from the freshly prepared control and test media flask. At the end of the test media renewal (24 and 48-hours), 10 mL old media samples were taken from pooled control and test vessels. The samples were taken using an air displacement pipette fitted with a plastic pipette tip. Samples were standardly sampled into 20 mL amber glass scintillation vials.
In each case triplicate samples were taken (A, B, C) one for immediate chemical analysis and two as a ‘back-up’ should further analysis be required

- Sample storage conditions before analysis: samples were transferred to the chemistry department under ambient conditions for storage and analysis, as appropriate. The “A” samples were analysed on the day of sampling. The 0-hour “B” and “C” samples were analysed after 1 days frozen storage to confirm a potential sampling error

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The 100 mg active ingredient/L solution was prepared by adding 189.52 or 189.60 mg of test substance to 500 mL of Elendt M4.
- Controls: the test solutions were checked for the Tyndall effect. the concentration was checked by chemical analysis after 24 and 48 h.
- Evidence of undissolved material: The turbidity meter confirmed that there was no dispersed test substance present.
- Other relevant information: As the test substance was light sensitive, the test substance was weighed and its solutions prepared under red light. The preparations were made in either amber glassware or glassware wrapped in foil to prevent light exposure.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water fleas
- Origin of test organism: These cultures were set up originally from dormant eggs (ephippia) supplied by MicroBioTests Inc., Belgium.
- Age at study initiation: less than 24 h old
- Stage and instar at study initiation: Juveniles
- Age of parental stock (mean and range, SD): Cultures were usually discarded at or before Day 35. Juveniles for use in acute toxicity tests were collected from the second brood onwards.
- Feeding during test: no

ACCLIMATION
- Acclimation conditions: All cultures, prior to and during toxicity tests, are maintained under fluorescent
lighting on a 16-hour light: 8-hour dark photoperiod with a 30-minute dusk/dawn phase.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

266 CaCO3/L

Test temperature:

18.9 -19.4 °C (see table 2 for details)

pH:

7.7-8.1 (see table 2 for details)

Dissolved oxygen:

101.1 -105.3 % (see table 2 for details)

Conductivity:

609 (µS/cm)

Nominal and measured concentrations:

nominal 100 mg/L; measured 97.3 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Type (delete if not applicable): closed, covered with clear plastic petri dish lids.
- Volume of solution: 50 mL

- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: Elendt M4 Medium was used with reverse osmosis water
(see table 3 for detailed composition)
- Intervals of water quality measurement: before every medium renewal

OTHER TEST CONDITIONS
- Photoperiod: 16-hour light: 8-hour dark with a 30-minute dusk/dawn phase.

EFFECT PARAMETERS MEASURED:
After 24 and 48 Hoursmobility was observed. An individual was considered immobile if it did not swim during a 15-second period of observation.
In addition, Daphnia magna submerged in the body of the test media and those that were held at the surface of the test media were also recorded.

RANGE-FINDING STUDY
- Test concentrations: Control, 0.1, 1, 10 and 100 mg active ingredient/L (equivalent to 0.379, 3.79, 37.9 and 379 mg test substance/L)
- Results used to determine the conditions for the definitive study: No immobilisation was recorded at any treatment during the test.

Reference substance (positive control):

yes

Remarks:

Potassium dichromat; test not part of this GLP study

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 97.3 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Details on results:

No adverse effects were observed in test concentration and control

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Limit test: no
- Concentrations: Control, 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L
- EC50 (48 h) 1.6 mg/L

Reported statistics and error estimates:

No statistical analysis was performed on this test, as there was 0% immobilisation during the test. The EC10 and EC50 concentrations were determined empirically by observing the data and were reported to be at or above the limit test concentration, as applicable.

Validity criteria fulfilled:

yes

Conclusions:

No adverse effect were observed up to the highest tested concentration (limit test with 100 mg/L)

Executive summary:

The 24-hour and 48-hour acute toxicity of Zinc-phthalocyanine sulphonate in water on the freshwater planktonic crustacean, Daphnia magna, was determined in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).
Based on nominal active ingredient concentrations, the 24-hour and 48-hour EC10 and EC50 values were determined to be >100 mg/L.
Based on arithmetic mean measured active ingredient concentrations, the 24-hour and 48-hour EC10 and EC50 values were determined to be >97.3 mg/L.
The validity criteria for control immobility (≤ 10 %) and dissolved oxygen (≥ 3 mg/L) were both satisfied. The test is therefore considered valid.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

other: USEPA 1975 Methods for acute toxicity tests with fish, macroinvertebrates and ampphibianes EPA-660/3-75-009

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Penaeus duorarum

Details on test organisms:

TEST ORGANISM
- Common name: Penaeus duorarum, pink shrimp
- Source: Big Lagoon, FL
- Age at study initiation (mean and range, SD): juvenile shrimp
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 20 - 30 mm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14
- Acclimation medium (same as test or not): the same as in the test, natural seawater
- Health during acclimation (any mortality observed): mortality was estimated to be < 3 %

Test type:

static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22 +/- 1 °C

pH:

after 96 hours: 7.8

Dissolved oxygen:

after 96 hours: 2.8 mg/L (36 % of saturation)

Salinity:

20 °/oo

Nominal and measured concentrations:

Test concentrations nominal: control and 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass jars
- Size, fill volume: 19 L, 15 L
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- natural seawater

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1000 ppm
- Results used to determine the conditions for the definitive study: yes

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 747 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

< 747 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Description of key information

With high probability acutely not harmful to aquatic invertebrates.

EC50 (48h) > 100 mg/L (nominal) for Daphnia magna (OECD 202)

LC50 (96h) > 747 mg/L (nominal) for Penaeus duorarum (salt water) (EPA-660/3-75-009)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Remarks:

nominal

Effect concentration:

> 100 mg/L

Marine water invertebrates

Marine water invertebrates

Dose descriptor:

LC50

Remarks:

nominal

Effect concentration:

> 747 mg/L

Additional information

The acute toxicity of the test item to aquatic invertebrates was assessed in two different key studies according to GLP regulations and OECD guideline 202.

Since the test item is an UVCB the concentrations based on the active ingredients (AI). In both tests, test materials with diffferent concentrations were used. In both tests no adverse effects were observed up to highest measured concentrations.

Daphnia magna was exposed to a limit concentration of 100 mg/l  test item and a control for 48 h. A test item with 26.4 % AI was used (BASF, 2021). No adverse effect was observed. Therefore the EC50 was set to >100 mg/L.

The same result was achieved in an experimental study with a similar test design using a test material with 9.33 % AI (Procter & Gamble, 1978).

In a supporting study the toxicity of the test item to aquatic invertebrates was investigated according to USEPA 1975 Methods for acute toxicity tests with fish, macroinvertebrates and amphibianes EPA-660/3-75-009 (Procter & Gamble 1978). In this study the pink shrimp Penaeus duorarum was exposed to the substance for 96 hours in a salt water limit test with a nominal concentration of 1000 mg/L (nominal) under static conditions. At test termination the LC50 > 747 mg/L (nominal) was determined.