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

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

Please find the attached justification.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 500 mg/L

Remarks on result:

other: Result of RA Source record CAS 1328-53-6 (BASFSE, 1988); no effects up to the limit of water solubility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 50 mg/L

Remarks on result:

other: Result of RA Source record Phthalocyanine (Jancula, 2008); likely no effects up to the limit of water solubility

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

OECD 202 limit test. No detail on procedure followed, only results presented.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

GLP compliance:

not specified

Specific details on test material used for the study:

- Test substance: Phtalocyanin-AI-Komplex
- Code No.: Tinolux BBS
- Batch-No.: 021422D7
- Purity: 11.5 (%)
- Appearance: blue liquid
- Solubility: miscible
- Storage: room temperature
- Expiration date: not indicated by the sponsor

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

not specified

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Nominal and measured concentrations:

- Nominal concentrations: 0 (control) and 100 mg/L
- Measured concentrations: not reported.

Details on test conditions:

TEST SYSTEM
- No. of organisms per vessel: 10
- No. of vessels per concentration: 2
- No. of vessels per control: 2

EFFECT PARAMETERS MEASURED:
Mobility after 24 and 48 hours

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 11.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

No immobility observed during the test period.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

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:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

May, 1984

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 72-2 (Aquatic Invertebrate Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Version / remarks:

1979

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Heliogen Gruen 8730
- Batch No.: BW 32
- Purity: 98%
- Water solubility: slightly

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Tween 80

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: the substance was added as a supplement to Tween 80 and subsequently diluted with water. This stock contained 500 mg/L test substance and 100 mg/L vehicle. The stock was stirred for 10 minutes at 20 °C. The stock solution was further diluted with water to obtain a dilution series of which 10 mL was added to the test vessels to obtain the required nominal test concentrations.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Straus
- Source/culture: The used strain of daphnids was obtained from the Institut National de Recherche Chimique, Appliquee, France, and has been further cultured in the BASF laboratory for environmental analysis and ecology since the beginning of 1978.
- Age: 2 - 24 h

CULTURE CONDITIONS
- Same as test conditions

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.7 ± 0.5 mmol/L

Test temperature:

19 - 21 °C

pH:

ca. 7.4 - 7.8

Dissolved oxygen:

ca. 6.5 - 9.4 mg/L

Conductivity:

550 - 650 µSiemens/cm

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 62.5, 125, 250 and 500 mg/L
- Measured concentrations: no analysis performed.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass with flat bottom
- Fill volume: 10 mL
- Aeration: no, although test medium was aerated with oil-free air and left to stabilize at least 24 hours prior to use
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Medium: filtered and dechlorinated tap water
- Ca/mg ratio: 4:1
- Na/K ratio: 4:1
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: day/night rhythm of 16:8 hours
- Light intensity: diffuse light (ca. 5 µE·m-2·s-1 at a wavelength of 400-750 nm)

EFFECT PARAMETERS MEASURED:
Mobility after 0, 3, 6, 24 and 48 hours

VEHICLE CONTROL PERFORMED:
yes

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Remarks on result:

other: no effects up to the limit of water solubility

Details on results:

Both at test concentrations of 62.5 mg/L and 500 mg/L 1 of 20 daphnids was found immobile at 48 hours after exposure. No other abnormailities are reported.

Validity criteria fulfilled:

yes

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Version / remarks:

1996

GLP compliance:

no

Specific details on test material used for the study:

The test substance was synthesized by Research Institute of Organic Synthesis (VUOS PLC), Rybitvi, Czech republic.

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

No information available.TEST ORGANISM
- Common name: water flea
- Age of parental stock (mean and range, SD): < 24h
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

21 ± 2 °C

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 0.01, 0.1, 1, 10 and 50 mg/L
- Measured concentrations: concentrations were not analytically verified

Details on test conditions:

TEST SYSTEM
- Test vessel: polystyrene plates with 10 mL vessels#
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Medium used: standard exposure solution containing basic inorganic salts (according to ISO 6341 (1996)

OTHER TEST CONDITIONS
- Light intensity: 20 µmol·m-2·s-1
- Photoperiod: 14/10-h light/dark period

EFFECT PARAMETERS MEASURED: mobility, after 48 hours

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: likely no effects up to the limit of water solubility

Details on results:

No effects observed in control and any treatment.

Results with reference substance (positive control):

Not reported.

Reported statistics and error estimates:

Linear regression analysis of inhibition percentage versus extract concentration along with the 95% confidence intervals.

Validity criteria fulfilled:

yes

Description of key information

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

Additional information

A study performed with the substance itself was considered to contain insufficient documentation and was thus by itself not suitable for classification purposes. Therefore, additional data on close structural analogues is presented as part of a weight of evidence approach. Although no analytical verification of test concentrations has been performed in these studies, it may be assumed that test organisms were exposed to the water-soluble fraction of test substance for the entire exposure period: the stability of these molecules play an important role in their application; no hydrolysis, photolysis, adsorption, biodegradation or evaporation of this molecule in/from the test medium is expected.

The acute toxicity to aquatic invertebrates was determined for the close structural analogue Pigment Green 7 (CAS 1328-53-6) in a study according to EU method C.2 (BASF 1988). In this study daphnids (D. magna, 20 per concentration) were exposed to nominal concentrations of 0 (control), 62.5, 125, 250 and 500 mg/L for 48 hours under static conditions. Concentrations were not analytically verified. Immobilization was recorded after 0, 3, 6, 24 and 48 hours after application. At concentrations 62.5 and 500 mg/L one daphnid was immobile after 48 hours. Other, no mortality occurred. Based on these findings the 48-h EC50 value was determined at > 500 mg/L.

Furthermore, Jancula et al (2008) studied a close structural analogue (Me = Al; R1,2 =SO3Na, R3,4 = H) in a static daphnia test, the methods equivalent or similar to ISO 6431. In this test, dapnnids (D. magna, 20 per concentration) were exposed to test concentrations of 0, 0.01, 0.1, 1, 10 and 50 mg/L for 48 hours. No information on analytical confirmation of test concentrations is presented. Immobilization was determined after 48 hours. No immobilization was observed up to the highest tested concentration. Based on these findings, the 48-h EC50 value was determined to be > 50 mg/L.

In the study performed with the actual test substance itself, the acute toxicity to aquatic invertebrates was determined in a limit test according to OECD TG 202, where daphnids (D. magna, 20 per concentration) were exposed to nominal concentrations of 0 and 100 mg/L for 48 hours under static conditions (BASF 1998). No information on analytical confirmation is presented. Immobilization was determined after 24 and 48 hours exposure. No immobilization was observed at 100 mg/L or the blank. Based on these findings the 48-h EC50 value was, considering the purity of the compound, determined at > 11.5 mg/L (nominal concentration 100 mg/L).

The target substance and two close structural analogues show no adverse effects in aquatic invertebrates. Overall, no effects were observed up to the limit of water solubility and thus the substance is not considered to be harmful to aquatic invertebrates.