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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets requirements of OECD Guideline 211 and GLP requirements with no deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP according to OECD principles

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
Solubility limit is below the analytical detection limit.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of a saturated solution with nominal 1 mg/l test substance as follows:
A stock dispersion was prepared for each test interval by adding 5 mg of the test substance into a 250 mL beaker. Approximately 150 mL water was added and the mixture was homogenized with an ultra-turrax and by ultrasonification (30 minutes). The mixture was than transferred into a graduated flask, filled up to a volume of 5 L with water for dilution (= 1 mg test substance / L) and stirred for 48 hours with a magnetic stirrer. After a sedimentation phase of 1 hour 100 mL portions of the test dispersion were collected from the middle of the stock dispersion vessel using a glass pipette and subsequently transferred to the test vessels.
The test vessels were preconditioned with test solution to prevent adsorption of the test substance which perhaps would reduce the test concentration below the solubility limit . The test vessels were filled with test solution (nominal concentration 1 mg/L), gently swirled and then the test solution was discarded.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No visible particulate matter, slight yellowish clear solution throughout study;

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphinia magna
- Strain/clone: Clone 5
- Source: Stock culture of Hoechst Marion Roussel Deutschland GmbH, ProTox
- Age of parental stock (mean and range, SD): <24h
- Feeding during test
- Food type: Scenedesmus subspicatus (green algae)
- Amount: 0.2 mg carbon / day / animal
- Frequency: every 24 hours
Acclimation period: not specified
Breeding:
- Type and amount of food: 0,2 mg carbon / day / animal, Scenedesmus subspicatus (green algae)
- Feeding frequency: three times a week

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Post exposure observation period:
none

Test conditions

Hardness:
Total hardness (mmol Ca2+ + Mg2+/ L):
Control: 2.3 - 2.5
Treatment: 2.1 - 2.5
Test temperature:
Temperature (°C)
Control: 21.1 - 21.2
Treatment: 21.0 - 21.2
pH:
Control: 7.7 - 7.9
Treatment: 7.8 - 8.0
Dissolved oxygen:
Oxygen content (mg/L):
Control: 8.8 - 9.1
Treatment: 8.8 - 9.3
Nominal and measured concentrations:
Due to the very low solubility of the substance it can be estimated, that the actual concentration is equal to or lower than 20µg/l.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: Open 150 ml beakers, 100 ml of test water;
- Aeration: The test water was aerated until oxygen saturation before used in the test. During the test oxygen content was monitored.
- Renewal rate of test solution (frequency/flow rate): Every Monday, Wednesday and Friday.
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted fresh water prepared from demineralized water with a conductance of < 1 µS / cm and defined solutes according to Elendt M4;
- Intervals of water quality measurement: The pH-value, oxygen content, conductivity and total hardness were measured and recorded once a week.


OTHER TEST CONDITIONS
- Adjustment of pH: Phosphate buffer to pH 7,7-8,0
- Photoperiod: 16h/day
- Light intensity: 300 lx

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
The tested concentration of 1 mg/L is already above the limit of solubility of the test substance in water ( <=20 µg/L).

Any other information on results incl. tables

Reproduction rate

No differences in the onset of brood production were observed in the concentration group in comparison to the control. The reproduction rate in the concentration group showed no statistically significant changes in comparison to the control.


control

1 mg/L
C.I. Pigment Yellow 74

n

10

10

mean of living offspring

132.9

131.3

standard deviation

18.56

21.64

coefficient of variation

14.0

16.5

median

132.5

123.0

n = number of daphnids exposed per concentration

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In this prolonged toxicity study with C.I. Pigment Yellow 74 in Daphnia magna over 21 days the following effect concentrations were obtained:

NOEC (immobility) > 1 mg/L (nominal concentration)
> solubility limit (< =20 µg/L)

NOEC (reproduction rate) > 1 mg/L (nominal concentration)
> solubility limit (< =20 µg/L)

No adverse effects of C.I. Pigment Yellow 74 an Daphnia magna were observed at the maximum tested concentration of 1 mg/L (nominal concentration) which was above the solubility limit (< =20 µg/L) of the test substance in the test water.
Executive summary:

C.I. Pigment Yellow 74 was tested in Daphnia magna (water flea) over 21 days in a semistatic system. Since no effects were expected up to the limit of solubility a limit test with a nominal concentration of 1 mg/L was conducted.

A negative control (0 mg/L) and a nominal concentration of 1 mg/L were tested. The tested concentration is already above the limit of solubility of the test substance in water ( <=20 µg/L).

The test was conducted under semistatic conditions. The media and the test solutions were renewed every Monday, Wednesday and Friday. For every renewal new test solutions were prepared. This was done by stirring the test substance for 48 hours into the test medium. The aqueous phase of the concentration group was present as a slight yellowish clear solution during the entire exposure period. There were no visible particulate matters. Water parameters were within the normal range.

Analytical monitoring of the concentration of the test substance in the test water was not conducted since no relevant results could be expected. The solubility limit of the test substance is below the analytical detection limit. From the properties of the test substance it could be concluded that the test substance is chemically stable in water over the test intervals of 48 and 72 hours, respectively.

The concentration values given in this report are based an the nominal concentration.

In the control group no mortality occurred and the mean number of living offspring produced per parent animal was 132.9, thus fulfilling the validity criteria for the test.

No immobility occurred in the 1 mg/L (nominal concentration) 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 in the concentration group showed no statistically significant changes in comparison to the control.

In this prolonged toxicity study with C.I. Pigment Yellow 74 in Daphnia magna over 21 days the following effect concentrations were obtained:

NOEC (immobility)                    > 1 mg/L (nominal concentration)

> solubility limit (<=20 µg/L)

NOEC (reproduction rate)        > 1 mg/L (nominal concentration)

> solubility limit (<=20 µg/L)