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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sepisol fast Blue 85219
- Substance type: organic salt - UVCB
- Appearance/Physical state: dark blue powder
- Stability under test conditions: stable
- Storage condition of test material:room temperature
Specific details on test material used for the study:
- Batch 310551

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 14 ml of test item diluted in 1 L liters of ultra-pure water (stock solution).
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not mentionned

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia Magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
Room temperature
pH:
7.7 à 7.9 from T0 to T48h
Dissolved oxygen:
8.2 mg/L to 8.3mg/L at T0
7.2mg/L to 8.0 mg/L at T48H
Nominal and measured concentrations:
Nominal concentration:
0.18 - 0.11 - 0.063 - 0.036 - 0.021 - 0.011 - 0.007 - 0.0042 - 0.0025 - 0.0014 mg/L
Details on test conditions:
TEST SYSTEM
- Type of flow-through : static
- No. of organisms per vessel: 20
- No. of vessels per concentration : 4
- No. of vessels per control (replicates): 4

TEST CONCENTRATIONS
- Range finding study: 12.6 - 4.9 - 1.4 - 0.5 - 0.14 - 0.05 - 0.014 - 0.0049 mg/L
- Test concentrations: 0.18 - 0.11 - 0.063 - 0.036 - 0.021 - 0.011 - 0.007 - 0.0042 - 0.0025 - 0.0014 mg/L
- Results used to determine the conditions for the definitive study:
12.6 mg/L: 100% immobilisation
4.9 mg/L = 100% immobilisation
1.4 mg/L = 100 % immobilisation
0.5 mg/L = 100 % immobilisation
0.14 mg/L = 100 % immobilisation
0.05 mg/L = 90% immobilisation
0.014 mg/L = 20% immobilisation
0.0049 mg/L = 0% immobilisation



Reference substance (positive control):
yes
Remarks:
K2Cr2O7

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.012 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Remarks on result:
other: 95% CI : 0.0095-0.015
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.006 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Remarks on result:
other: 95% CI: 0.0047-0.0069
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.003 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50 (24h) = 1.0 mg/L
Reported statistics and error estimates:
EC 50 was calculated by using Log-Probit statistical model (software Toxcalc)
NOEC was calculated by using the Bonferroni t-test (software Toxcalc).

Any other information on results incl. tables

ASSAY:

 

T = 24 hours

Concen-

tration (mg/L)

0.18

0.11

0.063

0.036

0.021

0.011

0.007

0.0042

0.0025

0.0014

Control

I

0

0

0

0

2

3

5

3

5

5

5

II

0

0

0

1

1

3

2

4

5

5

5

III

0

0

1

1

2

4

3

5

5

5

5

IV

0

0

0

0

1

2

3

4

5

5

5

Total moving

0

0

1

2

6

12

13

16

20

20

20

Immobilization rate %

100%

100%

95%

90%

70%

40%

35%

20%

0%

0%

0%

 

T = 48 hours

Concen-

tration (mg/L)

0.18

0.11

0.063

0.036

0.021

0.011

0.007

0.0042

0.0025

0.0014

Control

I

0

0

0

0

0

1

3

2

4

5

5

II

0

0

0

0

1

1

1

4

5

5

5

III

0

0

0

1

0

0

2

4

4

5

5

IV

0

0

0

0

0

0

1

4

5

5

5

Total moving

0

0

0

0

1

2

7

14

18

20

20

Immobilization rate %

100%

100%

100%

100%

95%

90%

65%

20%

0%

0%

0%

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the experimental conditions:
24-h EC50=0.012 mg/L (IC 95% : 0.0095; 0.015)
48-h EC50=0.0057 mg/L. (IC 95% : 0.0047; 0.0069)
48-h NOEC= 0.0025 mg/mL
Executive summary:

The short-term toxicity (48 hours) on invertebrate (Daphnia magna) of the test item Sepisol Fast Blue 85219 was assessed by determining the nominal effective concentration (EC 50%) at which 50 % of the test animals are immobilized. The method followed was the standard NF EN ISO 6341 under static condition.

 

EC50 (48h) values and associated confidence limits were calculated using a Log-Probit statistical model (software Toxcalc) and NOEC was worked out by using the Bonferroni t-test (software Toxcalc).

Test System: A stock solution (14 mg/mL) of the test substance was prepared in ultra-pur water.

Immobilisations and viable abnormalities were recorded at 24 and 48 hours as well as pH and dissolved oxygen.

Validity criteria were fulfilled and study was considered as valid..

A preliminary assay was performed at the following concentration: 12.6 - 4.9 - 1.4 - 0.5 - 0.014 - 0.0049 mg/L

Test Levels: Test concentrations included control, 0.18 - 0.11 - 0.063 - 0.036 - 0.021 - 0.011 - 0.007 - 0.0042 - 0.0025 - 0.0014 mg/L. Twenty daphnia were used per test group. 3 replicates were performed.

 

Conclusion:

 24-h EC50=0.012 mg/L (IC 95%: 0.0095-0.015)

 48-h EC50=0.0057 mg/L (IC 95%: 0.0047-0.0069)

48-h NOEC= 0.0025 mg/mL