Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Nominal test concentrations were not analytically verified.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Principles of method if other than guideline:

No analytical verification of test concentrations.

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): FAT-60'149/E
- Expiry date: February 1992
- Batch No.: EN 199474/06
- Purity: According to the sponsor's files (analytical certificate): 65 - 70%
- Stability: guaranteed by the sponsor
- Solubility: miscible
- Storage: room temperature
- Appearance: liquid

Analytical monitoring:

no

Details on sampling:

Test concentrations were not analytically determined.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test substance was dissolved in 200 mL water, which was slowly added to the fish bath (up to 3 liters).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: West Aquarium, Bad Lauterberg, BRD
- Age at study initiation: 130 days
- Length at study initiation: 31.0 mm
- Weight at study initiation: 0.27 g

ACCLIMATION
- Acclimation period: 54 days in dechlorinated tap water
- Acclimation conditions: same as test

FEEDING DURING TEST: no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

161 mg/L (as CaCO3)

Test temperature:

21.4 - 22.5 °C ± 0.6°C

pH:

7.6 - 8.2

Dissolved oxygen:

90 - 99 %

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 562 and 1000 mg/L (based on range-finding study)
- Measured concentrations: no test substance analysis performed.

Details on test conditions:

TEST SYSTEM
- Test vessel: 5 L glass aquaria, volume of 3 L
- Aeration: slowly aerated
- No. of vessels per concentration: 10
- No. of vessels per control: 10

OTHER TEST CONDITIONS
- Photoperiod: yellow light; 12 hours daily

EFFECT PARAMETERS MEASURED:
Mortality and abnormal responses of the fish were recorded after 3, 24, 48, 72 and 96 hours exposure.

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 100, 300 and 1000 ppm

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 650 - <= 700 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

No abnormal responses of the fish were observed. No mortality occurred at the blank control or any of the concentrations tested. The NOEC is ≥1000 mg/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

other: GB/T 29763-2013 Chemicals - rare minnow (Gobiocypris rarus) acute toxicity test

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Eluate: 1.0006g test substance was dissolved in 1L test water to prepare the stock solution with a nominal concentration of 1g/L. The test solutions were prepared by dilution of the stock solution with test water.

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

TEST ORGANISM
- Common name: rare minnow
- Source: bred in Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement (ID: GR-SAPM-161209).
- Age at study initiation (mean and range, SD): ca. 8 months
- Length at study initiation (length definition, mean, range and SD): 2.2 ± 0.1cm
- Weight at study initiation (mean and range, SD): 0.21 ± 0.03 g

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: fish were fed with brine shrimp flake (O.S.I®, USA)
- Feeding frequency during acclimation: daily until 24 hours before the test was started.
- Health during acclimation (any mortality observed): No diseases were observed during the acclimation period. No mortality was observed within the 7 days before the start of the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

21.2 - 22.2 °C

pH:

6.93 - 7.48

Dissolved oxygen:

82.7 - 98.8% saturation

Nominal and measured concentrations:

Nominal: 120 mg/L
Measured (geometric mean): 119 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Five litre glass tanks were used containing 4L test solution.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.5g fish/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp, was used. The water was aerated continuously over 24h.
- Culture medium different from test medium: no
- Intervals of water quality measurement: Oxygen, Ph and temperature was recorded 0, 3, 24, 48, 72 and 96 hours after test initiation.

OTHER TEST CONDITIONS
- Photoperiod: Light/Dark=12 hours/12 hours

EFFECT PARAMETERS MEASURED: The fish were inspected at 0, 3, 24, 48, 72 and 96 hours after test initiation and mortalities were recorded

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 119 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortality was observed in the cntrol and the treatment.

Sublethal observations / clinical signs:

For evaluation of the fish quality and experimental conditions, potassium dichromate was tested as a positive control to demonstrate satisfactory test conditions once a year (recently performed on 2017.6.19-6.23). The 96h LC₅₀value of the test substance toGobiocypris rarus(ID: GR-SAPM-161209) was 195mg/L (95% confidence limits: 153-244mg/L), which was within the±2SD range of the QC chart in our lab (83.2-312mg/L).

Validity criteria fulfilled:

yes

Conclusions:

The test substance is not harmful to freshwater fish.

Description of key information

No effects were observed up to the limit of water solubility.

Additional information

Two studies investigating the short-term toxicity of the test substance to freshwater fish are available. One study was performed according to OECD TG 203 and in compliance with GLP criteria (BASF 1992). In this study, groups of 10 zebrafish (Danio rerio) were exposed to nominal test concentrations of 0 (control), 562 and 1000 mg/L for 96 hours under static conditions. The nominal test concentrations were not analytically verified. The stability of this molecule plays an important role for its application; since no hydrolysis, photolysis, adsorption, biodegradation or evaporation of this molecule in/from the test medium is expected, it may be assumed that test organisms were exposed to the water-soluble fraction of test substance for the entire exposure period. Fish mortality and general symptoms of toxicity were recorded after 3, 24, 48, 72 and 96 hours exposure. In this study the OECD validity criteria are met. No mortality abnormal responses of the fish were observed during the test. Thus, the 96 h-LC50 value was, considering the purity of the compound, determined to be > 650 mg/L. The second study was performed according to OECD guideline 203 and GLP using Gobiocypris rarus as test organism (BASF 2017). A limit test was performed using a nominal test concentration of 120 mg/L. The test concentration was analytically confirmed (119 mg/L). No mortality abnormal responses of the fish were observed during the test. Thus, the 96h-LC50 value is determined to be > 119 mg/L based on measured concentrations. Based on these findings the substance is not considered to be harmful to freshwater fish.