Sepisol Fast Violet 2B

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

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 (NF EN ISO 6341), which describes a procedure designed to evaluate this endpoint. The results were reviewed for reliability and assessed as valid. Howerver the study was not conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.

IUPAC Name:

Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.

Details on test material:

- Name of test material (as cited in study report): Sepisol Fast Violet 2B
- Lot/batch No.: 423393
- Substance type: organocopper
- Physical state and appearance: violet dark powder
- Stability under test conditions: stable
- Storage condition of test material: at ambient temperature

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 and corresponding pH of 2,8 (with pure water)

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

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

Room temperature

pH:

7.3 à 7.9 from T0 to T48h

Dissolved oxygen:

7.6 mg/L to 8.3mg/L at T0
7.1 mg/L to 7.7 mg/L at T48H

Nominal and measured concentrations:

Nominal concentration:
1.8 - 1.1 - 0.62 - 0.37 - 0.22 - 0.13 - 0.074 - 0.044 - 0.026 - 0.015 - 0.009 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Erlenmeyer
- Type of flow-through : static
- No. of organisms per vessel: 5
- No. of vessels per concentration : 4
- No. of vessels per control (replicates): 4

TEST CONCENTRATIONS
- Range finding study: 1.8 - 0.7 - 0.2 - 0.07 - 0.02 - 0.007 - 0.02 mg/L
- Test concentrations: 1.8 - 1.1 - 0.62 - 0.37 - 0.22 - 0.13 - 0.074 - 0.044 - 0.026 - 0.015 - 0.009 mg/L

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.37 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI : 0.29-0.49

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.044 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI: 0.031-0.061

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.015 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: K2Cr2O7
- 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)	1.8	1.1	0.62	0.37	0.22	0.13	0.074	0.044	0.026	0.015	0.009	Control
I	0	0	2	3	2	4	4	5	5	5	5	5
II	0	3	2	3	2	4	4	5	5	5	5	5
III	0	0	1	3	5	4	5	5	5	5	5	5
IV	0	1	1	4	4	4	5	5	5	5	5	5
Total moving	0	4	6	13	13	16	18	20	20	20	20	20
Immobili-zation rate %	100%	80%	70%	35%	35%	20%	10%	0%	0%	0%	0%	0%

analytic assay: 2469

dissolved 02 at 1.8 mg/L: 7.3 mg/L 

 

T = 48 hours
Concen- tration (mg/L)	1.8	1.1	0.62	0.37	0.22	0.13	0.074	0.044	0.026	0.015	0.009	Control
I	0	0	0	2	1	1	1	1	4	3	5	5
II	0	0	1	0	2	0	1	2	2	4	5	5
III	0	0	0	1	0	2	1	2	2	4	5	5
IV	0	0	0	0	1	2	3	2	2	5	5	5
Total moving	0	0	1	3	4	5	6	7	10	16	20	20
Immobili-zation rate %	100%	100%	95%	85%	80%	75%	70%	65%	50%	20%	0%	0%

analytical assay: 2469

dissolvedd 02 at 1.1 mg/L: 7.1 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the experimental conditions:
24-h EC50=0.37 mg/L (IC 95% : 0.29; 0.49)
48-h EC50=0.044 mg/L. (IC 95% : 0.031; 0.061)
48-h NOEC= 0.015 mg/mL

Executive summary:

The short-term toxicity (48 hours) on invertebrate (Daphnia magna) of the test item Sepisol Fast Violet 2B 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 (2 mg/mL) of the test substance was prepared in distilled 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: 1.8 - 0.7 - 0.2 - 0.07 - 0.02 - 0.007 mg/L

Test Levels: Test concentrations included control, 1.8 - 1.1 - 0.62 - 0.37 - 0.22 - 0.13 - 0.074 - 0.044 - 0.026 - 0.015 - 0.009 mg/L. Twenty daphnia were used per test group. 4 replicates were performed.

 

Conclusion:

 24-h EC₅₀=0.37 mg/L (IC 95%: 0.29 -0.49)

 48-h EC₅₀=0.044 mg/L (IC 95%: 0.031 -0.061)

48-h NOEC= 0.015 mg/mL