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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: read across from similar substance
Adequacy of study:
key study
Study period:
07/06/2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
other: Real Decreto 363/1995 (BOE núm. 133 de Junio de 1995)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)
EC Number:
265-016-4
EC Name:
7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)
Cas Number:
64683-40-5
Molecular formula:
C22H17N5O7S2.2C6H15NO3
IUPAC Name:
7-amino-4-hydroxy-3-({4-[(4-sulfophenyl)diazenyl]phenyl}diazenyl)naphthalene-2-sulfonic acid - 2,2',2''-nitrilotriethanol (1:2)

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution has been prepared with a concentration of 2.857 g/L of the test material. Therefore, 2.857 g of the test material have been dissolved in 1000 mL of water in a volumetric flask, Class A 1000 mL by stirring and resulting on a stock solution of 1000 mg/L. Because the test material contains 35% of active ingredient, the stock solution is of a concentration of 1000 mg/L of active material.
The different solutions used in the test have been prepared from this stock solution of 1000 mg/L active material.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
(Teleostei, Cyprinidae) (Hamilton-Buchanan) (pez cebra)
Procedencia: P & S, S.L
- size (cm): 2.86 ± 0,18
- weight (g): 0.29 ± 0,12
- Maintenance conditions:
o Temperature: 22 ºC ± 2
o Photoperiod: 12 hours of ligth / 12 hours of darkness
o Concentration of dissolved oxigen:> 60%
o Feeding:
· Feed type: Commercial flakes for fish feeding
· Frequency of feeding: 3 times/week, until 24 hours before the start of the test
· Acclimatization: minimum 12 days
· Mortality: 0%

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
120 mg CaCO3/L
Test temperature:
22 ºC ± 2
pH:
8,11
Dissolved oxygen:
> 70%
Nominal and measured concentrations:
nominal: 0,1 mg/L, 1 mg/L, 10 mg/L y 100 mg/L active material, plus one control (only water)
measured: 0,10 mg/L, 1,00 mg/L, 10,00 mg/L y 100,04 mg/L active material
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Number of died fishes during the test

 conc (mg/L)
   0h  24h  48h  72h  96h
 control  0  0  0  0  0
 0.1  0  0  0  0  0
 1  0  0  0  0  0
 10  0  0  0  0  0
 100  0  0  0  0  0

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test material does not produces any mortality in Brachydario rerio at the concentration of 100 mg/L of active material.