Reaction products of 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, coupled twice with diazotized 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

16. to 23 October 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

not specified

Details on sampling:

- Concentrations: 0, 1, 10, 100, 500 mg/L

Vehicle:

yes

Details on test solutions:

TS was diluted in water by ultra sonification and distributed evenly in the tank by means of a glass stirrer.

Test organisms (species):

Leuciscus idus melanotus

Details on test organisms:

TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus idus melanotus
- Source: Paul Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 5.5 to 6.5 cm; mean: 6 cm; SD: 0.37
- Weight at study initiation (mean and range, SD): 1.7 to 2.5 g; mean: 2.1 g; SD: 0.27; n=10
- Feeding during test: none


ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions:
- Dilution water (ISO/DIS 7346/1)
- 20 °C
- pH 8.32 to 8.4
- Type and amount of food: Tetra Min, Tetra Werke, Melle
- Feeding frequency: twice/day

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

96 hours

Hardness:

total: 9.5 °d
carbonate: 6.4 °d

Test temperature:

19 to 21 °C

pH:

7.9 to 8.4

Dissolved oxygen:

8.2 to 8.9 mg/L

Salinity:

NA

Nominal and measured concentrations:

nominal: 0, 1, 10, 100, 500 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass; 40x25x30 cm³; 20 liter water
- Aeration: 100 mL/min
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): at least one
- No. of vessels per control (replicates): at least one
- No. of vessels per vehicle control (replicates): NA


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionized tap water (Christ-Ministil Ion-Exchanger cartridge) conductance value < 5 µS/cm enriched with:
192 mg/L NaHCO3
120 mg/L CaSO4 x 2H2O
120 mg/L MgSO4
8 mg/L KCl
- Conductivity: < 5 µS/cm
- Intervals of water quality measurement: directly prior TS, after 2, 24, 48, 72, 96 hours


OTHER TEST CONDITIONS
- Photoperiod: 12/12 h
- Light intensity: ca. 700 Lux


EFFECT PARAMETERS MEASURED
Mortality, behavior, macroscopic abnormities

Reference substance (positive control):

not required

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

100 - 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: 500 mg/L deaths between 23 and 95 hours; swimming at water surface; supine position; no effects at 1 to 100 mg/L
- Necropsy:dead animals: blue discoloration of fins and mouth; brown-green discoloration of bile
100 mg/L: test substance deposition in GI-tract; white crystals in gall-bladder
no effects at 1 to 10 mg/L
- Mortality: 48 h: 1/10 at 500 mg/L; 96 h: 10/10 at 500 mg/L
- Mortality of control: no effects
- Other adverse effects control: no effects
- Abnormal responses: no effects
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
- Other: due to the staining nature of the TS, the water was dark-blue discolored

Results with reference substance (positive control):

NA

Reported statistics and error estimates:

NA

Validity criteria fulfilled:

yes

Conclusions:

The LC0 and LC100 after 48 and 96 hours is between 100 and 500 mg/L. Hence, its concluded that 96 h LC50 of the test substance to fish is >100 mg/l.

Executive summary:

In an 96 h acute fish toxicity test, the test substance was assessed by following method comparable to today’s standard testing procedure published by the OECD within Guideline for Testing of Chemicals 203: Fish, Acute Toxicity Test, adopted by the Council on 17thJuly 1992. The fish were exposed to the test substance at 0, 1, 10, 100, 500 mg/L concentrations and observed till 96 h for mortality.

The LC0 and LC100 after 48 and 96 hours is between 100 and 500 mg/L. Hence, its concluded that 96 h LC50 of the test substance to fish is >100 mg/l.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18. to 25 April 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

not specified

Details on sampling:

- Concentrations: 0, 1, 10, 100, 500 mg/L

Vehicle:

yes

Details on test solutions:

The test substance was diluted in water by ultra sonification and distributed evenly in the tank by means of a glass stirrer.

Test organisms (species):

Leuciscus idus melanotus

Details on test organisms:

TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus idus melanotus
- Source: Paul Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 5.4 to 6.3 cm; mean: 5.9 cm; SD: 0.35
- Weight at study initiation (mean and range, SD): 1.4 to 2.6 g; mean: 1.8 g; SD: 0.37; n=10
- Type of food: Tetra Min, Tetra Werke, Melle


ACCLIMATION
- Acclimation period: at least 14 days at 20 °C
- Type of food: Tetra Min, Tetra Werke, Melle
- Feeding frequency: twice/day

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

NA

Hardness:

total: 9.5 °d
carbonate: 6.4 °d (1.14 mmol/L)

Test temperature:

19 to 21 °C

pH:

8.2

Dissolved oxygen:

above 7 mg/L

Nominal and measured concentrations:

nominal: 0, 1, 10, 100, 500 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass; 40x25x30 cm³; 20 liter water
- Aeration: 100 mL/min
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): at least one
- No. of vessels per control (replicates): at least one
- No. of vessels per vehicle control (replicates): NA


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionized tap water (Christ-Ministil Ion-Exchanger cartridge) conductance value < 5 µS/cm enriched with:
192 mg/L NaHCO3
120 mg/L CaSO4 x 2H2O
120 mg/L MgSO4
8 mg/L KCl
- pH: 8.0 to 8.4
- Oxygen: 7.6 to 8.3 mg/L
- Conductivity: <5 µS/cm
- Intervals of water quality measurement: directly prior TS, after 2, 24, 48, 72, 96 hours


OTHER TEST CONDITIONS
- Photoperiod: 12/12 h
- Light intensity: ca. 700 Lux


EFFECT PARAMETERS MEASURED
Mortality, behavior, macroscopic abnormities

Reference substance (positive control):

not required

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

100 - 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

100 - 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: 500 mg/L deaths at 46 hours; swimming at water surface; reduced gill movements; no effects at 1 to 100 mg/L
- Necropsy:500 mg/L: blue discoloration of fins and gills and the upper part of the vitreous body
no effects at 1 to 100 mg/L
- Mortality: 48 h: 10/10 at 500 mg/L; 96 h: 10/10 at 500 mg/L
- Mortality of control: no effects
- Other adverse effects control: no effects
- Abnormal responses: no effects
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
- Other: due to the staining nature of the TS, the water was dark-blue discolored

Validity criteria fulfilled:

yes

Conclusions:

The LC0 and LC100 after 48 and 96 hours is between 100 and 500 mg/L. Hence, its concluded that 96 h LC50 of the test substance to fish is >100 mg/l.

Executive summary:

In an 96 h acute fish toxicity test, the test substance was assessed by following method comparable to today’s standard testing procedure published by the OECD within Guideline for Testing of Chemicals 203: Fish, Acute Toxicity Test, adopted by the Council on 17th July 1992. The fish were exposed to the test substance at 0, 1, 10, 100, 500 mg/L concentrations and observed till 96 h for mortality.

The LC0 and LC100 after 48 and 96 hours is between 100 and 500 mg/L. Hence, its concluded that 96 h LC50 of the test substance to fish is >100 mg/l.

Description of key information

The LC50 of the test substance to freshwater fish is >100 mg/l. Hence, the substance is not toxic to aquatic vertebrates.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

In a publication from Ministry of the Environment Government of Japan, 96 h acute toxicity test with test substance was assessed according to OECD Guideline 203 and in compliance with GLP. Fish, Oryzias latipes, were exposed to single concentration of the test substance at 100 mg/L and observed for 96h. No mortality was observed. The LC50 of the test item to fish after 96 hours is determined to be >100 mg/L.

 

Two other supporting studies which were performed following OECD Guideline 203 showed LC50 value of >500 mg/L.

 

Reactive Black 5 rapidly degrades to its oxy-form in water. It is therefore reasonable to test this main metabolite in aquatic toxicity tests. Data from a read-across substance generated by following a OECD 203 guideline in compliance to GLP is taken into consideration here to analyze the toxicity of the test substance. The LC50 of the read-across substance in freshwater fish after 96 hours was also noted to be above 500 mg/L

 

Taking data from above mentioned studies into account and also data from the read across substance, the LC50 of the test substance to freshwater fish is >100 mg/l. Hence, the substance is not toxic to aquatic vertebrates.