Registration Dossier

Diss Factsheets

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:
From 2011-05-31 to 2011-06-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliabitity is rated 2 because the study followed a standard guideline of reference (OECD 202), which describes a procedure designed to evaluate this endpoint. The results were reviewed and assessed as valid. However the study was not conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
EC Number:
700-761-5
Molecular formula:
not applicable
IUPAC Name:
tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
Details on test material:
- Name of test material (as cited in study report): Sepisol Fast Red SN
- Substance type: organic salt - UVCB
- Physical state: red-magenta powder
- Lot/batch No.: 029244

Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): 2 mg/l

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Strain: Straus clone 5)
- Source: EBSE Metz, France
- Age at study initiation: < 24h, at least from the third brood progeny.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
Total hardness = 250 mg/L +/- 25 mg (CaCO3)
Test temperature:
20.5 to 21.1 °C
pH:
From 7.7 to 7.9 at T0
From 7.1 to 7.3 at T48h
Dissolved oxygen:
From 7.9 to 8.0 at T0
From 7.2 to 7.4 at T48h
Nominal and measured concentrations:
Nominal concentrations: 0.44, 0.58, 0.74, 1.00, 1.20, 1.60 and 2.00 mg/L
Details on test conditions:
TEST SYSTEM
- Type of flow-through: static
- Material, size, headspace, fill volume: glass test tubes filled with a 10 mL volume
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic medium according the NF EN ISO 6341
- Ca/mg ratio: (4/1) +/- 0.5
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: none

TEST CONCENTRATIONS
- Spacing factor for test concentrations: square root of around 2
- Range finding study: 100 - 35 - 10 - 3.5 - 1 - 0.35 - 0.1 and 0.035 equivalent to 2 - 0.7 - 0.2 - 0.07 - 0.02 - 0.007 - 0.002 and 0.0007 mg/kg
- Test concentrations: 0.44, 0.58, 0.74, 1.00, 1.20, 1.60 and 2 mg/L
- Results used to determine the conditions for the definitive study: At the highest concentration (= at the limit of solubility in the medium test), the percentage of immobilisation is egal to 40%. So the highest dose for the full study was egal to this highest dose (2 mg/kg).
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr207)

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CI 1.4->2 mg/L
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
0.44 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance, K2Cr2O7, are valids
- EC50-48h: 1.0 mg/L
Reported statistics and error estimates:
EC50 calculated using the Log-Probit statistical model (Toxcalc software)

Any other information on results incl. tables

Main Studies :

T = 24 h

Concentrations

mg/L

2

1.6

1.2

1

0.74

0.58

0.44

Control

I

4

5

4

5

5

5

5

5

II

4

5

5

5

5

5

5

5

III

4

4

4

5

5

5

5

5

IV

3

3

4

5

5

5

5

5

Total moving

15

17

17

20

20

20

20

20

Immobilisation rate (%)

25%

15%

15%

0%

0%

0%

0%

0%

Analytic serial number: 3071

 

T = 48 h

Concentrations

mg/L

2

1.6

1.2

1

0.74

0.58

0.44

Control

I

3

4

3

4

4

4

5

5

II

2

3

5

4

4

5

5

5

III

2

3

3

3

4

4

5

5

IV

2

2

3

4

4

5

5

5

Total moving

9

12

14

15

16

18

20

20

Immobilisation rate (%)

55%

40%

30%

25%

20%

10%

0%

0%

 

Analytic serial number: 3071

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the experimental conditions:
* 24h - EC50 > 2 mg/L
* 48h - EC50 = 1.8 mg/L
* 48h - NOEC = 0.44 mg/L
Executive summary:

The short-term toxicity (48h) on invertebrate (Daphnia magna) of the test item Sepisol Fast RED SN was assessed by determining the nominal effective concentration (EC50) at which 50% of the Daphnia are immobilized. The method followed the OECD guideline 202 under static condition.

EC0 and EC50 values and associated confidence limits were calculated using a Log-Probit statistical model (software Toxcalc).

The test substance was prepared in distilled water to obtain a stock solution of 2 mg/L. No solvents were used to facilitate the dispersion of the test item. Immobilisation and viable abnormalities were recorded at 24h and 48h as well as pH and dissolved oxygen.

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

A preliminary assay was performed at the following concentrations: 100 - 35 - 10 - 3.5 - 1 - 0.35 - 0.1 and 0.035 %

The main assay was performed at the following test concentrations: 2 - 1.6 - 1.2 - 1 - 0.74 - 0.58 and 0.44 mg/L + a control, in quadruplicate, with 20 daphnia per test and control groups.

Conclusion:

* 24h - EC50 = > 2 mg/L

* 48h - EC50 = 1.8 mg/L (CI 95% : 1.4 - > 2 mg/L)

* 48h - EC0 = 0.44 mg/L

Categories Display