Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from peer - reviewed journals

Qualifier:

according to guideline

Guideline:

other: TLM was determined according to the procedure in JIS K0102 (Japenese Industrial Standards Committee, 1971)

Principles of method if other than guideline:

Short term toxicity study to Oryzias latipes was carried out for 48 hrs.

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

Details on sampling
Concentrations: 3,000 mg/l
Sampling method: No data available
Sample storage conditions before analysis: No data available

Vehicle:

not specified

Details on test solutions:

no data

Test organisms (species):

Oryzias latipes

Details on test organisms:

Common name: Himedaka
Strain: No data available
Source: No data available
Age at study initiation (mean and range, SD): Age of fish was not mentioned in paper, but fishes of same age were chosen for study.
Length at study initiation (length definition, mean, range and SD): 2 cm long
Weight at study initiation (mean and range, SD): 0.2 gm
Method of breeding: No data available
Feeding during test: No data available
Food type: No data available
Amount: No data available
Frequency: No data available

ACCLIMATION
Acclimation period: 10 days
Acclimation conditions (same as test or not): Test fishes were acclimatized in the tap water for 10 days before the start of the experiment.
Type and amount of food: No data available
Feeding frequency: No data available
Health during acclimation (any mortality observed): No data available

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 deg C

pH:

7

Nominal and measured concentrations:

nominal concentration

Details on test conditions:

Test vessel: Tank
Type (delete if not applicable): No data available
Material, size, headspace, fill volume: No data available
Aeration: Aeration in the tank was provided with bubbler.
Type of flow-through (e.g. peristaltic or proportional diluter): No data available
Renewal rate of test solution (frequency/flow rate): No data available
No. of organisms per vessel: 10 fishes
No. of vessels per concentration (replicates): Triplicates
No. of vessels per control (replicates): No data available
No. of vessels per vehicle control (replicates): No data available
Biomass loading rate: No data available

TEST MEDIUM / WATER PARAMETERS
Source/preparation of dilution water: No data available
Total organic carbon: No data available
Particulate matter: No data available
Metals: No data available
Pesticides: No data available
Chlorine: No data available
Alkalinity: No data available
Ca/mg ratio: No data available
Conductivity: No data available
Culture medium different from test medium: No data available Intervals of water quality measurement: No data available

OTHER TEST CONDITIONS
Adjustment of pH: No data available
Photoperiod: No data available
Light intensity: No data available
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Survival rate (in %) of fish was determined and Median Tolerance Limit (TLm) was also calculated by counting the number of survival fish after 24 and 48 hrs.

TEST CONCENTRATIONS
Spacing factor for test concentrations: No data available
Justification for using less concentrations than requested by guideline: No data available
Range finding study: No data available
Test concentrations: 3,000 mg/l (Nominal concentration)
Results used to determine the conditions for the definitive study: No data available

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

3 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 100% survival rate of fishes. The values were mean of three trials.

Sublethal observations / clinical signs:

Table 1: Median tolerance limit test of Food dyes

 

Food dyes (3000mg/l)	Survival rate of fishes (%)*
Amaranth	100

 

The values were mean of three trials

* - 10 fish of Himedaka were used to test and the number of fish alive was counted after 48 hours.

Validity criteria fulfilled:

not specified

Conclusions:

Different food dyes were subjected to median tolerance limit (TLm) test by use of Himedaka (Oryzias Latipes) for the comparison of the toxicity.
Survival rate of 10 fishes determined after 48 hours.
100% survival rate was determined after 48 hours exposure of fishes to Amaranth
Based on these observations, the test chemical can be considered non-toxic to fishes.

Executive summary:

Different food dyes were subjected to median tolerance limit (TLm) test by use of Himedaka (Oryzias Latipes) for the comparison of the toxicity. Himedaka(Oryzias Latipes) was used.The same age fish (about 2 cm long, weight ca 0.2 g) were chosen and acclimated for 10 days in the tap water before experiment. One liter of deionized water was placed in a 2 liter tank.The food dyes were obtained from National Institute of Hygienic Sciences, Japan.

Survival rate test:

In one liter of pH 7.0 containing 3000mg/l of dye solution, 10 fishes were kept in the tank without direct sunlight for 48 hours. Water temperature was 20C. Aeration was performed with bubbler.  TLm test: TLm was determined according to the procedure in JIS K0102 (Japanese Industrial Standards Committee, 1971). Amaranth was tested at 4 – 6 steps of concentration utilizing ten fish per one group and the number of survivals were counted after 24 and 48 hours. The values were mean of 3 trials.  

100% survival rate was determined after 48 hours exposure of fishes to Amaranth. Based on these observations, the test chemical can be considered non-toxic to fishes.

Description of key information

Different food dyes were subjected to median tolerance limit (TLm) test by use of Himedaka (Oryzias Latipes) for the comparison of the toxicity. Himedaka(Oryzias Latipes) was used.The same age fish (about 2 cm long, weight ca 0.2 g) were chosen and acclimated for 10 days in the tap water before experiment. One liter of deionized water was placed in a 2 liter tank.The food dyes were obtained from National Institute of Hygienic Sciences, Japan. Survival rate test: In one liter of pH 7.0 containing 3000mg/l of dye solution, 10 fishes were kept in the tank without direct sunlight for 48 hours. Water temperature was 20C. Aeration was performed with bubbler.  TLm test: TLm was determined according to the procedure in JIS K0102 (Japanese Industrial Standards Committee, 1971). Amaranth was tested at 4 – 6 steps of concentration utilizing ten fish per one group and the number of survivals were counted after 24 and 48 hours. The values were mean of 3 trials. 100% survival rate was determined after 48 hours exposure of fishes to Amaranth. Based on these observations, the test chemical can be considered non-toxic to fishes.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3 000 mg/L

Additional information

From the available experimental data for the target chemical, the information is summarized as below:

In the first study from The Journal of Toxicological Sciences Different food dyes were subjected to median tolerance limit (TLm) test by use of Himedaka (Oryzias Latipes) for the comparison of the toxicity. Himedaka(Oryzias Latipes) was used.The same age fish (about 2 cm long, weight ca 0.2 g) were chosen and acclimated for 10 days in the tap water before experiment. One liter of deionized water was placed in a 2 liter tank.The food dyes were obtained from National Institute of Hygienic Sciences, Japan.

Survival rate test:

In one liter of pH 7.0 containing 3000mg/l of dye solution, 10 fishes were kept in the tank without direct sunlight for 48 hours. Water temperature was 20C. Aeration was performed with bubbler.  TLm test: TLm was determined according to the procedure in JIS K0102 (Japanese Industrial Standards Committee, 1971). Amaranth was tested at 4 – 6 steps of concentration utilizing ten fish per one group and the number of survivals were counted after 24 and 48 hours. The values were mean of 3 trials. 100% survival rate was determined after 48 hours exposure of fishes to Amaranth. Based on these observations, the test chemical can be considered non-toxic to fishes.

Similarly in the second estimated data from ecotox, The acute toxicity of Amaranth dye to fishes was estimated using ECOSAR v 1.11. The estimated LC50 values for fish after 96 hours of exposure with chemical 2,7-Naphthalenedisulfonic acid, 3- hydroxy-4-[2-(4-sulfo-1-naphthalenyl)diazenyl]-, sodium salt (1 :...; Amaranth dye; trisodium 3-hydroxy-4- [(4-sulfonato-1-naphthyl) diazenyl]naphthalene-2,7-disulfonate was 950.627 mg/l. Based on the estimated data, 2,7-Naphthalenedisulfonic acid, 3- hydroxy-4-[2-(4-sulfo-1-naphthalenyl)diazenyl]-, sodium salt (1 :...; Amaranth dye; trisodium 3-hydroxy-4-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-2,7-disulfonate was consider as nontoxic and can be consider to be not classified as per the CLP classification criteria.