Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-11-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The reliabitity is rated 2 because the study followed the standard guidelines of reference (OECD 203 and OECD 126- limit test), 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OCDE Guideline 126

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate

EC Number:

700-615-0

Molecular formula:

BIS: C82H74N14CuS2O6 TRIS: C107H103N17CuS3O9 TETRA: C132H132N20CuS4O12

IUPAC Name:

Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate

Details on test material:

- Name of test material (as cited in study report): Sepisol Fast Violet 3B
- Substance type: Organocopper salt
- Physical state: Dark violet powder
- Lot/batch No.: 028942
- Expiration date of the lot/batch: 2013-05-24

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

- Concentrations: 0.1 mg/L
- Sample storage conditions before analysis: Dilution of 2.0 mg of the test substance in 1L of the test medium, followed by 20 to 24 h of mixing

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Brachedanio rerio
- Source: fish farming from a laboratory provider.
- Length at study initiation (length definition, mean, range and SD): 26.9 mm +/- 2.0 mm

Study design

Test type:

static

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg/L +/- 25 mg (CaCO3)

Test temperature:

23 +/- 1°C

pH:

7.8 +/- 0.2

Dissolved oxygen:

> 7 mg/L

Nominal and measured concentrations:

tested concentration : 0.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquarium
- Material, size, headspace, fill volume: 10 liters of tested volume/ aquarium
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): non renewel - Static mode
- No. of organisms per vessel: 10 fish/aquarium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:Preparation of the test medium according the norm EN ISO 6341
- Ca/mg ratio: 4/1 +/- 0.5

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light / 8h dark
- Light intensity: 1000 lux at the vessels surface

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none, one testing dose
- Justification for using less concentrations than requested by guideline: application of the threshold approach
- Test concentrations: 0.1 mg/L
- Results used to determine the conditions for the definitive study: no need to perform the definitive study

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

no mortality and no abnormal behavior were observed after a 96h exposure period in the test group at the threshold concentration of 0.1 mg/L.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50-24h : 213 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

	TO		T +24h		T +48h		T +72h		T +96h
Concentration mg/L	0.1	control	0.1	control	0.1	control	0.1	control	0.1	control
pH	7.8	7.6	8.0	7.8	7.9	7.7	8.0	7.8	7.9	7.8
Dissolved O2 (% of the air saturation)	97.2	99.5	93.0	92.5	89.1	88.9	89.1	88.8	87.8	88.0
Death fish	0/10	0/10	0/10	0/10	0/10	0/10	0/10	0/10	0/10	0/10

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

After short term exposure, the test item Sepisol Fast Violet 3B is not toxic at the threshold concentration of 0.1 mg/L. Thus, the fish is not the most sensitive group of test organism.

Executive summary:

The threshold approach for acute fish toxicity testing according the OECD guideline n°126 was used to performed the fish acute toxicity test according the OECD guideline n°203.

Based on reliable algae and acute daphnia toxicity data (according the OECD guidelines n°201 and 202 respectively), a threshold concentration of 0.1 mg/L was selected to performed the limit test on fish.

The threshold concentration was equal to the lowest concentration obtained, that is to say: ErC50 – 72 h (algae) = 0.098 mg/L.

 

After an exposure period of 96h of 10 fish, no mortality and no abnormal behavior were observed.

All validity criteria were fulfilled.

Thus, the fish is not the most sensitive group of test organism, and no full study has been perfomed.