Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental test result performed using standard OECD test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
This study was designed to assess the toxic effects of the test compound on the Zebra Fish (Danio rerio).Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
222-656-9
EC Name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
3567-66-6
Molecular formula:
C16H13N3O7S2.2Na
IUPAC Name:
disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate- Molecular formula (if other than submission substance): C16-H13-N3-O7-S2.2Na- Molecular weight (if other than submission substance): 467.3889 g/mol- Substance type: Organic - Physical state: Reddish brown powder- Analytical purity: 93.54% (Pure dye content)- Lot/batch No.: FG/15-16/2641- Expiration date of the lot/batch: December, 2023-Storage Conditions-•Ambient Temp (23 to 27 °C)

Sampling and analysis

Analytical monitoring:
yes

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM- Common name:Zebra Fish - Strain:Danio rerio - Source:Unique Aqua Fish Corner- Age at study initiation (mean and range, SD): No data available.- Length at study initiation (length definition, mean, range and SD):3.23 cm - Weight at study initiation (mean and range, SD):0.203 g (approx.)0.322 g- Feeding during test: No - Food type:Standard brand feed,- Frequency: once dailyACCLIMATION- Acclimation period: 6 days - Acclimation conditions (same as test or not):yes - Type and amount of food:Standard brand feed,- Feeding frequency:once daily up to sixth day of acclimatization- Health during acclimation (any mortality observed): No

Study design

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

Test conditions

Hardness:
147.5
Test temperature:
25°C
pH:
7.01
Dissolved oxygen:
7.06 mg/L
Salinity:
No data available.
Nominal and measured concentrations:
100 mg/L.
Details on test conditions:
TEST SYSTEM- Test vessel: The test vessels used were all plastic aquaria having the water capacity of 5liters.- Type (delete if not applicable): open / closed- Material, size, headspace, fill volume:- Aeration:Aeration in test vessels was provided 1 day before the start of experiment- Type of flow-through (e.g. peristaltic or proportional diluter):- Renewal rate of test solution (frequency/flow rate):- No. of organisms per vessel: 4- No. of vessels per concentration (replicates):2- No. of vessels per control (replicates):1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: The fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration.OTHER TEST CONDITIONS- Adjustment of pH:- Photoperiod: 12 hours light and 12 hours darkness- Light intensity:
Reference substance (positive control):
not specified

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortality and symptoms

 

NominalConcentration

(mg/l)

Number of fish

Mortality (cumulated) after

3 h

6 h

24h

48h

72h

96h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

0 (control)

4

4

-

-

-

-

-

-

-

-

-

-

-

-

100

4

4

-

-

-

-

-

-

-

-

-

-

-

-

 

Visible Symptoms

NominalConcentration

(mg/l)

Number of fish

Symptoms after

3 h

6 h

24h

48h

72h

96h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

0 (control)

4

4

-

-

-

-

-

-

-

-

-

-

-

-

100

4

4

-

-

-

-

-

-

-

-

-

-

-

-

 

Explanation of symptoms:

A:apathy

N:Narcotic-like state

C:Swimming near water surface

M: Slow movements compared to control

NS:No abnormal symptoms 

S:Surfacing behaviour

L:Loss of equilibrium

SM:Shimming movement

H1:Hyperactivity

H2:Hypo activity

B:Bending behavior

F:Fin rot

IS:Invert Swimming

SB:Swimming behaviour

RF:Respiratory Function

P:Pigmentation

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for CAS No. 3567-66-6 on Zebra Fish were found to be>100mg/L.
Executive summary:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for __________. The nominal concentration selected for the experiment were ____________ and Zebra fish were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L.