29H,31H-phthalocyanine

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:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non-GLP study, no analytical measurements

Qualifier:

according to guideline

Guideline:

other: EPA-660/3-75-009

Version / remarks:

1975

Principles of method if other than guideline:

U.S. Environmental Protection Agency; Brauhn et.al, Acquisition and culture of research fish: rainbow trout, fathead minnows, channel catfish and bluegills. EPA-660/3-75-001 (1975) Committee on Methods for Toxicity Tests with Aquatic Organisms. Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians. EPA-660/3-75-009 (1975)

GLP compliance:

no

Analytical monitoring:

no

Details on test solutions:

- For each concentration the test substance was (to a precision of 0.1 mg) introduced into test vessel containing dilution water, thoroughly mixed and then the fish were introduced.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: Bluegill sunfish(Lepomis macrochirus Rafinesque)
- Source: Commercial fish hatchery in Nebraska
- Age at study initiation (mean and range, SD): 5 months
- Length at study initiation (length definition, mean, range and SD): 35 mm
- Weight at study initiation (mean and range, SD): 0.50 g
- Method of breeding: Labor culture

ACCLIMATION
- Acclimation period: 24 hours prior testing
- Acclimation conditions (same as test or not): same



FEEDING DURING TEST
- No

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

22.3 ±0.7 °C

pH:

7.10 - 7.69

Dissolved oxygen:

- dissolved oxygen (0 h): 8.8 - 9.4 mg/l
- dissolved oxygen (48 h): 6.6 - 8.0 mg/l
- dissolved oxygen (96 h): 4.8 - 6.0 mg/l

Conductivity:

175 µmhos/cm

Nominal and measured concentrations:

nominal test concentrations: control, 100, 180, 320, 560 and 1000 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass jars
- Material, size, headspace, fill volume: glass, 15 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.33 g/l

TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 31 mg/l (as CaCO3)
- Intervals of water quality measurement: mortality after 24, 48 and 96 h

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8

Reference substance (positive control):

yes

Remarks:

p,p'-DDT

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

752.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

560 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

- Results with reference substance valid?
- LC50: 4.03 (3.59 - 4.52) µg/l

Sublethal observations / clinical signs:

Mortality

Test concentration [mg/L]	24 h	48 h	96 h
Control	0	0	0
100	0	0	0
180	0	0	0
320	0	0	0
560	0	0	0
1000	8	10	10

 

Dissolved oxygen (mg/L)

Concentration [mg/L]	Initial	48 h	96 h
Control	9.0	6.2	5.7
100 mg/L	9.4	6.6	6.0
320 mg/L	9.2	8.0	4.8
1000 mg/L	8.8	n.d.	n.d.

 

pH values

Concentration [mg/L]	Initial	48 h	96 h
Control	7.44	7.22	7.21
100 mg/L	7.47	7.69	7.23
320 mg/L	7.45	7.69	7.10
1000 mg/L	7.47	*	*

 

 

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Non-GLP, no analytical measurements

Qualifier:

according to guideline

Guideline:

other: EPA-660/3-75-009

Version / remarks:

1975

Principles of method if other than guideline:

U.S. Environmental Protection Agency;
Brauhn et.al, Acquisition and culture of research fish: rainbow trout, fathead minnows, channel catfish and bluegills. EPA-660/3-75-001 (1975) Committee on Methods for Toxicity Tests with Aquatic Organisms. Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians. EPA-660/3-75-009 (1975)

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Fastolux Green

Analytical monitoring:

no

Details on test solutions:

For each concentration the test substance was (to a precision of 0.1 mg) introduced into test vessel containing dilution water, thoroughly mixed and then the fish were introduced.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout (Oncorhynchus mykiss)
- Source: commercial hatchery in Washington
- Age at study initiation (mean and range, SD): approx. 4 months
- Length at study initiation (length definition, mean, range and SD): 50 mm
- Weight at study initiation (mean and range, SD): 1.03 g
- Method of breeding: were cultured in the UCES laboratory

ACCLIMATION
- Acclimation period: 24 hours prior test start
- Acclimation conditions (same as test or not): same

FEEDING DURING TEST
- no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

44 mg/l (as CaCO3)

Test temperature:

12 ±0.5 °C

pH:

7.23 - 7.53

Dissolved oxygen:

7.7 - 9.3 mg/l

Conductivity:

175 µmhos/cm

Nominal and measured concentrations:

nominal test concentrations: control, 100, 180, 320, 560 and 1000 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass jars
- Material, size, headspace, fill volume: glass, 15 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.69 g/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: from a well on the Tarrytown site, treated with a Continental Reverse Osmosis Water System and deionized
- Alkalinity: 31 mg/l (as CaCO3)
- Intervals of water quality measurement: initially and efter 24, 48 and 96 h

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality after 24, 48 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: nominal: control, 100, 180, 320, 560 and 1000 mg/l

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

355.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

95% Confidence Interval: 298.1 - 424.1 mg/L

Sublethal observations / clinical signs:

Mortality

Test concentration [mg/L]	24 h	48 h	96 h
Control	0	0	0
100	0	0	0
180	0	0	0
320	1	2	3
560	3	9	10
1000	10	10	10

 

Dissolved oxygen (mg/L)

Concentration [mg/L]	Initial	48 h	96 h
Control	9.2	8.6	7.7
100 mg/L	9.0	9.3	8.3
320 mg/L	8.9	8.1	7.7
1000 mg/L	9.1	n.d.	n.d.

 

pH values

Concentration [mg/L]	Initial	48 h	96 h
Control	7.48	7.34	7.19
100 mg/L	7.46	7.53	7.25
320 mg/L	7.48	7.30	7.23
1000 mg/L	7.48	*	*

 

 

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical measurements

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

- Lot/batch No.: M200058
- Name of test material (as cited in study report): Hostaperm Blau BT-729-B

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was added to the dilution water and homogenised using an Ultra-Turrax

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Bred at the laboratories of Aventis Pharma Deutschlang GmbH ProTox
- Length at study initiation (length definition, mean, range and SD): 2.7 cm (2.5 - 2.9 cm)
- Feeding during test: none


ACCLIMATION
- Acclimation period: 14 days
- Type and amount of food: Tetra Min, Tetra Werke, Melle, Germany; ad libitum
- Feeding frequency: twice daily

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

2.5 - 2.7 mmol/l

Test temperature:

21.4 - 21.7 °C

pH:

7.5 - 8.1

Dissolved oxygen:

6.5 - 8.8 (concentration group)
7.3 - 9.8 (control group)

Nominal and measured concentrations:

Nominal test concentration:
0 and 100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria (20 x15 x20 cm)
- Fill volume: 4 l
- Aeration: none
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to ISO/DIS 7346/1


OTHER TEST CONDITIONS
- Photoperiod: 12 h light
- Light intensity: 700 lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 3, 6, 24, 48, 72 and 96 h

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Undissolved test substance was observed at bottom of test vessels and on water surface.
The swimming behaviour and respiration rate of test fish was affected.

Sublethal observations / clinical signs:

Validity criteria:

There was no mortality of fish in any of the treatment groups at the end of the test.

The average temperature was in the range between 19.5 and 21.7 °C.

The average pH was 7.7 pH unit.

The oxygen content veried between 6.5 and 10.0 mg/L

Reference 4

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

Remarks:

no analytical monitoring, a solubiliser was used

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

- Lot/batch No.: 7051
- Name of test material (as cited in study report): Hostaperm Blue BG

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 4 g test substance were mixed with 4 g Tween 80 and filled up with test water to 40 l
- Controls: 4 g Tween 80 mixed with 40 l reconstituted water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Common carp
- Source: Fisheries Research Station, University of Agricultural Sciences, Bangalore, India
- Length at study initiation (length definition, mean, range and SD): 3.1 - 4.0



ACCLIMATION
- Acclimation period: 48 h
- Type and amount of food: commercial fish feed
- Feeding frequency: once daily
- Health during acclimation (any mortality observed): no mortality observed

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22 +/- 2 °C

pH:

7.88 +/-0.14

Dissolved oxygen:

82 +/- 8 %

Nominal and measured concentrations:

Nominal test concentrations:
control,
solvent control,
100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria (40 l)
- Type (delete if not applicable): open / closed
- Fill volume: 20 l
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: max. 1 g fish/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms after 1, 2, 4, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 100 mg/l
- Results used to determine the conditions for the definitive study: LC50 >100 mg/l

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No observation of symptoms of intoxication possible since test water was densely coloured by the test substance.

Reference 5

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:

no analytical monitoring, a solubiliser was used

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Colour-Chem Limited, Lot/batch No.: 90588
- Expiration date of the lot/batch: December 2004
- Purity test date: Since this is a pigment, chemical purity is not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient conditions

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Tween-80

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance (4 g) and Tween 80 (4 g) were added to 40 l test water
- Controls: 4 g Tween 80 dissolved in 40 l water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Common carp
- Source: Fisheries Research Station, University of Agricultural Sciences, Bangalore, India
- Age at study initiation (mean and range, SD): 0.21 - 0.92 g (test start); 0.18 - 0.88 (test end)
- Length at study initiation (length definition, mean, range and SD): 2.3 - 3.1 cm
- Weight at study initiation (mean and range, SD):

ACCLIMATION
- Acclimation period: at least 12 days prior to testing
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish feed
- Feeding frequency: once daily
- Health during acclimation (any mortality observed): no mortality observed

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.2 +/- 2 °C

pH:

7.99 +/- 0.16

Dissolved oxygen:

80 +/- 7 %

Nominal and measured concentrations:

Nominal test concentrations:
control,
solvent control,
100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria (40 l)
- Renewal rate of test solution (frequency/flow rate): every 24 h
- Aeration: the compressed air was used to maintain more than 80% of air saturation value
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: max. 1 g fish/l


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Intervals of water quality measurement: daily


OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 1, 2, 4, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1, 1.0, 10, 100 mg/l
- Results used to determine the conditions for the definitive study: LC50 >100 mg/l

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Symptoms of intoxication could not be observed in the test vessels since the test water was densely coloured by the test item.

Sublethal observations / clinical signs:

Validity criteria:

There was no mortality of fish in any of the treatment groups at the end of the test.

The average temperature was 22.2°C with a standard deviation of ± 0.2°C.

The average pH was 7.99 with a standard deviation of ± 0 16 pH unit.

The average dissolved oxygen concentration was 80% with a standard dev1ation of ± 7.

Table 1. Mean Temperature, pH and dissolved oxygen concentrations of test water.

Test concentrations [mg/L]	Temperature [°C]	pH	O2 [%]
Control	22.3	8.00	81
Vehicle control	22.2	8.00	79
100 (a.i)	22.1	7.97	81

Validity criteria fulfilled:

yes

Description of key information

The substance is not acutely toxic to fish, with an LC50 > 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 100 mg/L

Additional information

All substances in this category share a similar structure with a molecular weight > 500 g/mol. Based on the high molecular weight and insolubility, the substances in this category will not be able to penetrate biological membranes. Thus, no systemic exposure is expected. This is confirmed by the environmental studies on fish for three substances in this category: CAS 1328-53-6, CAS 147-14-8 and CAS 27614-71-7. The environmental toxicity data can be used for read-across to all substances in this category.

A  study on Cyprinus carpio was performed following OECD TG 203 with Polychloro copper phthalocyanine (CAS 1328-53-6). (Colour-Chem limited 2000, K2). Tween-80 (1g/L) was used as a vehicle in this limit test. No mortality of fish was observed at the end of the test. Therefore, the 96-h LC50 was determined to be > 100 mg/L. The result was supported by two non-GLP studies. These studies were conducted on Oncorhynchus mykiss and Lepomis macrochirus according to EPA-660/3-75-009 in static systems. No vehicle was used in both studies. The 96-h LC50 were determined to be 355.6 mg/L and 752.4 mg/L for Oncorhynchus mykiss (Sun Chemical Corporation 1978a, K2) and Lepomis macrochirus (Sun Chemical Corporation 1978b, K2), respectively.  In support of this result, the 96-h LC50 of CAS 147-14-8 was determined in an OECD TG 203 guideline study with Cyprinus carpio to be > 100 mg/L (Colour Chem 2001, K2). There are further experimental data on substance CAS 27614-71-7 from the study according to OECD TG 203 (96-h LC50 > 100 mg/L; Clariant GmbH, 2001, K2). Test concentrations were not analytically verified in these toxicity tests.

The determined LC50 values were significantly higher than the water solubility of the test substance. Based on the available information, it is concluded that all substances in this category are not acutely toxic to fish with an LC50 > 100 mg/L.