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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:
From 2014-08-05 to 2014-08-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability 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 for reliability and assessed as valid. The study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
(since the test item is poorly water soluble, the standard method for the preparation of aqueous media was modified. The test was performed with a saturated solution of the test item)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
anilino(phenylimino)methanaminium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
EC Number:
941-151-0
Molecular formula:
C31H28N6SO3
IUPAC Name:
anilino(phenylimino)methanaminium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Yellow MG-DPG
- Substance type: organic salt
- Physical state: powder
- Stability under test conditions: stable
- Storage condition of test material: ????
- Other: solubility = 140 mg/L

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method of preparation: Saturation of the experimental solution:
100 mg of test item was dispersed in 1 liters test medium
Stirring for 24 hours.
Filtration through a PTFE of 0.22 μm to remove undissolved test item
Obtention of a 100% v/v saturated solution.
Series of dilution to give further test concentration for the range finding study and the main test.

- Application: daphnies were placed in test tube containing 10 mL of the saturated solution test

- Controls: control group maintained under identical conditions but not exposed to the test item
- Vehicle: none
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house subcontracting laboratory cultures
- Age at study initiation: less than 24 hours old
- Method of breeding:
Breeding medium: Adult Daphnia were maintained in a synthetic medium as defined by the standard NF EN ISO 6341
Temperature: 18°C
Continuous lightning (intensity of 1000 lux on the containers surface)
No aeration
Containers: 3 litre glass beaker
Breeding charge: around 50 spawners per glass beaker
Breeding medium renewal frequency: twice per week
Spawners renewal frequency: around every 3 weeks
Test medium acclimatation of the spawners: no period of acclimatation

- Feeding during test: no

ACCLIMATION
- Acclimation period: no

QUARANTINE (wild caught)
- Duration:no quarantine

Study design

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

Test conditions

Hardness:
225 mg/L +/- 50 mg/L as CaCO3
Test temperature:
18°C to 22°C
Nominal and measured concentrations:
Nominal test concentration, in % v/v saturated solution :
a - control
b- 18 % v/v
c- 27 % v/v
d- 40 % v/v
e- 60 % v/v
f- 100 % v/v

Details on test conditions:
TEST SYSTEM
- Test vessel: glass test tube of 10 mL
- Type : closed
- Material, size, headspace, fill volume: 10 mL glass test tube
- Aeration: no
- Renewal rate of test solution: no renewal
- No. of organisms per vessel: 5 organisms
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: medium prepared according to the standard NF EN ISO 6341 (see table 2 for composition).

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continous lighting
- Light intensity: no light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- immobilisation of the daphnies

TEST CONCENTRATIONS
- Spacing factor for test concentrations: mean of √2.4
- Range finding study: yes
- Test concentrations: 18, 27, 40, 60 and 100 % v/v saturated solution
- Results used to determine the conditions for the definitive study: cumulative immobilization data from the range-finding study
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr207)

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
ca. 27 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: (95% CL: 84.4 - > 100 mg/l)
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance valid? yes. EC50 - 24 hr = 1.1 mg/L (2014/08/11)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the experimental conditions:
* 48h - EC50 > 100 mg/L
* 48h - NOEC = 27 mg/L
* 48h - LOEC > 100 mg/L
Executive summary:

Introduction

A study was performed to assess the acute toxicity of the test item to Daphnia magna.The method followed was designed to be compatible with OECD Guidelines. for Testing of Chemicals (April 2004) No 202,"Daphnia sp., Acute Immobilisation Test", referenced as method C.2 of Council Regulation (EC) No. 440/2008.

 

Methods

 

Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at concentrations of 1.0, 3.5, 10, 35 and 100% v/v saturated solution for 48 hours at a temperature of 20°C to 21°C under static test conditions.

The test item solutions were prepared by stirring an excess of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 µm Gelman Acrocap filter) to produce a 100% v/v saturated solution of the test item. This saturated solution was then further diluted as necessary, to provide the remaining test groups at 18, 27, 40, 60 and 100 mg/L. The number of immobilized Daphnia were recorded after 24 and 48 hours.

 

Results

 

Exposure of Daphnia magna to the test item gave the following results based on the geometric mean measured test concentrations:

-         EC50 – 48 hr > 100 mg/L (IC95%84.4 - > 100)

-         NOEC = 27 mg/l

-         LOEC > 100 mg/l