29H,31H-phthalocyanine

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study, GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): C.I. Pigment Blue 15:1
- Purity: 99.6 %

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
Since no effects were expected up to the limit of solubility (<=20 µg/l) a limit test with nominal concentration of 1 mg/l was conducted. A stock dispersion was prepared for each test interval by adding 5 mg of the test supstance into 250 ml beaker. Approximately 150 ml water was added and mixture was homogenized with an ultra -turrax and by unltrasonnification (30 min). The mixture was then transferred into a graduated flask , filled up to a volume of 5 land stirred for for 48 hours. After a sedimentation phase of 1 hour 100 ml portions of the of the test dispersion were collected from the middle of the of the stock dispersion vessel uising a glass pipette and subsequently transferred to the test vessels

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUSS
- Strain/clone: Clone 5
- Age at study initiation (mean and range, SD): < 24 hours
- Weight at study initiation (mean and range, SD):
- Source: Stock culture of Hoechst Marion Roussel Deutschland GmbH, ProTox
- Feeding during test: yes
- Food type: monocellular green algae
- Frequency: daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

2.0-2.5 mmol Ca2+ + mg2+/L

Test temperature:

20 ± 1 °C

pH:

7.7-8.2

Dissolved oxygen:

8.6-9.3 mg/L

Nominal and measured concentrations:

Nominal concentrations: 0 and 1 mg/L

Details on test conditions:

TEST PROCEDURE
The test vessels were pre-conditioned with test solution to prevent adsorption of the test substance which perhabs would reduce the test concentration below the solubility limit. The test vessels were filled with test solution (nominal conc 1mg/l) gentely swirled and then test solution was discarded.

- Semistatic procedure: Change of test solution three times a week.
- Number of animals/vessel: 1
- Number of replicates/concentration: 10
- Number of replicates/control: 10
- Age of the animals at the start of the test: 2 - 24 h

- Light: Artificial light, night-rhythm = 16 : 8 hours
- Removal of young from test beakers and counting: daily
- Check of the study and recording (mortality, hatching of young): daily
- Feeding: daily
- Measurement of pH and oxygen: At the start of the test and at each change of test solution in the 48- or 72-hour-old solution

STATISTICS: To find out whether the mean of living offspring is significantly reduced by substance effects statistical evaluation was carried out. On the premises of a monotonous concentration-effect-relationship the Wilcoxon-Test was applied.

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and reproduction rate

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and reproduction rate

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and reproduction rate

In the control group no mortality occured and the mean nummber of living  offspring / per parent was 120.2.

No immobility occured in the 1 mg/l and in the control group.
No difference in the onset of brood production was observed in the  concentration  group in comparison to the control.
The reproduction rate showed no statistically significant changes in  comparison to the control.

Validity criteria fulfilled:

yes

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical monitoring

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

September 1998

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): Heliogen Grün 8730 Pulver-2
- Source and lot/batch number of test material: V.9358
- Expiration date of the lot/batch: unlimited
- Purity: 100%;

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient
- Stability under storage conditions: guaranteed by the sponsor

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 stirred in M4 medium for about 20 hours at 20 ± 2 °C. Undissolved test substance was left in the stock solution. The nominal concentration of the stock solution was 1 mg/l.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: STRAUS 1820
- Source: cultured at the laboratories of BASF since 1978, originally obtained by Institut National de Recherche Chimique Appliquie, France
- Age of parental stock (mean and range, SD): 2-24 h
- Feeding during test: yes
- Food type: live green algae(Scenedesmus subspicatus)
- Frequency: daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Test temperature:

19.5 - 21.3°C

pH:

7.6 - 8.2

Dissolved oxygen:

8.3 - 9.7 mg/l

Nominal and measured concentrations:

Nominal test concentration:
control and 1 mg/l. The test concentration was above the limit of the water solubility (< 1 mg/l). No concentration control analyses (the recovery rate was 94-102% with 5 mg/l).

Details on test conditions:

TEST SYSTEM
- Test vessel: numbered glass beakers, nominal volume 100 ml, covered with glass caps.
- Fill volume: 50 ml
- Renewal rate of test solution (frequency/flow rate): each Monday, Wednesday, Friday
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 0.02 animals/ml



OTHER TEST CONDITIONS
- Photoperiod: 16 h day and 8 h night
- Light intensity: artificial light, type warm white (OSRAM L58 W31, about 1 - 8 µE/(m2.s) at a wave length of 400 - 700 nm


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
daily (mortality, embryos, aborted eggs)


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: range finding study
- Range finding study: yes
- Results used to determine the conditions for the definitive study: 48-h NOEC >= 1 mg/L

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Reported statistics and error estimates:

Due to the results of the test no statistical evaluation of the data.

Influence of test substance on reproduction and mortality of Daphnia magna after 21 days exposure period (mean values):

Total numbers	Control	1 mg/L
Surviving parent animals	10 / 10	10 / 10
Living young per surviving parent	128.3 ±22.6	137.6 ±23.0
Dead young per surviving animal	1.3 ±1.8	1.7 ±1.6
Aborted substance eggs per surviving parent animal	0.7 ±0.6	1.5 ±0.8

 

 

 

For a test to be valid, the following performance criteria should be met in the control(s):
- the mortality of the parent animals (female Daphnia) does not exceed 20% at the end of the test: the criterion is fulfilled 

 

- the mean number of living offspring produced per parent animal surviving at the end of the test is > 60: the criterion is fulfilled 

 

 

Validity criteria fulfilled:

yes

Description of key information

The substance is not chronically toxic to aquatic invertebrates, with a 21-d NOEC ≥ 1 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

>= 1 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 aquatic invertebrates for two substances in this category: CAS 1328-53-6 and CAS 147-14-8. The environmental toxicity data can be used for read-across to all substances in this category.

In both studies, Daphnia magna was used as the test organism, and no analytical measurements were performed. The long-term toxicity study of substance CAS 147-14-8 was conducted according to OECD TG 211 in a semi-static system. The 21-d NOEC for mortality and reproduction was determined to be > 1 mg/L (ETAD 1999, K2). A similar result was found in the study on substance CAS 1328-53-6 according to OECD TG 211. The 21-d NOEC for reproduction was determined to be >= 1 mg/L (BASF AG 2000, K1). 

The determined NOEC 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 chronically toxic to aquatic invertebrates, with a NOEC >= 1 mg/L.