Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

January from 21st to 25th, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

The read across approach is detailed into the document attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted 17 July, 1992

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Poecilia reticulata

Details on test organisms:

TEST ORGANISM
- Breeding: parental and young fish population was held in two 250 I glass aquaria.
- Length at study initiation: length of 1-3 cm
- lllumination: 16 h photoperiod a day, supplied by overhead white f luorescent tubes.
- Feed: Sera micropan, Sera vipan (Sera apanristic GmbH, D-52525 Heinsberg, Germany) daily. The fish were last fed 24 h before the start of the definitive test.
- Aquaria: every month, one third of the total volume of the aquaria was replaced by fresh tap water.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

21 ± 1 °C

pH:

Range: 8.1 - 8.7

Dissolved oxygen:

Range: 6.7 - 7.0 mg/l

Nominal and measured concentrations:

Nominal test concentration of 100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: 1 l aquaria, all-glass; the bottom of the aquaria was covered with gravel (<1.5 cm).
- Aeration: continuously aerated and filtered tap water from Schlieren.
- No. of organisms per vessel:7 f ish per test concentration.
- No. of vessels per concentration: 1 replicate
- No. of vessels per control: 1 replicate.

TEST MEDIUM / WATER PARAMETERS
Chemical composition of the tap water supplying the laboratory:
- pH: 7.1-7.4 (min-max)
- Conductivity (20'C): µS/cm 510-585 (min-max)
- TotalHardness: 17.7-31.9 °F (min-max)
- Rest - Hardness: 2.4-4.1 °F (min-max)
- CO3 - Hardness: 15.3-27.8 °F (min-max)
- CO3 - Hardness after Heyer: 15.2-26.9 °F (min-max)
- KMnO4-consumption: 1.0-1.3 mg/L (min-max)
- Sulfate: 17.5-21.0 mg/L (min-max)
- Phosphate as PO,-P: 0.002-0.038 mg/L (min-max)
- Chloride: 7.5-12.0 mg/L (min-max)
- Nitrate: 7.0-12.0 mg/L (min-max)
- Nitrite: <0.002- <0.002 mg/L (min-max)
- Ammonium: < 0.01- < 0.01 mg/L (min-max)
- Colony counts: at 20°C 0-0 (min-max); at 30°C 0-5 (min-max)
- E. Coli: per 100 mL 0-0 (min-max)

OBSERVATION
Observations of the fish were made atTer 2, 24, 48, 72 and 96 h of exposure. Mortality of the fish was recorded at the same time intervals.
Dead fish were removed immediately from the test medium and weight and length recorded.

MEASUREMENTS
- pH: misurated prior to the addition of fish to the test medium and after 2, 24, 48, 72 and 96 h of exposure.
- Dissolved oxygen: misurated prior to the addition of fish to the test medium and after 2, 24, 48, 72 and 96 h of exposure.
- Temperature: misurated prior to the addition of fish to the test medium and after 2, 24, 48, 72 and 96 h of exposure.

PRE-TEST
At least 1 h before the test the test vessels were filled with the medium to allow equilibration of pH, oxygen and temperature.
The nominal test concentration of 100 mg/l was prepared by dilution of a stock solution or, in case of poorly soluble compounds, by adding the test substance direclly to the test medium.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

At the nominal concentration of 100 mg/l none of a total of seven fish died after 96 h of exposure. No mortality was also observed in the blank control.
Other toxic effects than monality, e.g. loss of coordination, hypo- or hyperaclivity and swimming on the back, were not observed.

Validity criteria fulfilled:

yes

Conclusions:

LD50 (96h) > 100 mg/l (nominal)

Executive summary:

The acute lethal toxicity of test item to Poecilia reticulata (Guppy) was investigated under static exposure conditions over a period of 96 h. The only applied nominal test concentration was 100 mg/l. No chemical analysis of the test substance concentration was conducted. At the nominal concentration of 100 mg/l none of total of seven fish died after 96 h of exposure. No mortality was also observed in the blank control. Other toxic effects than mortality, e.g. loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed. The no-observed-effect concentration (NOEC) was ≥ 100 mg/. 100 % mortality (LC100) could not be detected. Based on the binominal theory, the absence of mortality provides at least 99 % confidence that the LC50 is greater than the applied nominal test concentration of 100 mg/l.

Conclusion

LD50 (96h) > 100 mg/l (nominal)

Description of key information

Not harmful/toxic to fish for short-term exposure (LD50 (96h) > 100 mg/l, nominal).

Additional information

Only an old non-GLP experiment is available on Direct Orange 118. The test was conducted on rainbow trout. Only a brief sheet of results is available, thus details about test method, procedures and test conditions are lacking. Therefore, a reliability cannot be assigned. The LC0 after 48 hours was indicated to be 800 ppm wt/vol; the LC50 value was indicated to be 1200 ppm wt/vol; the LC100 was indicated to be 2000 ppm wt/vol (Huntingdon Research Centre, 1975).

In order to confirm the short-term toxicity potential of Direct Oragne 118 to fish, available data on structural analogous Similar Substance 01 was also taken into account. The read across approach can be considered as reliable and suitable for the purpose; details are available in IUCLID section 13.

The acute lethal toxicity of test item to guppy was investigated under static exposure conditions over a period of 96 h. The only applied nominal test concentration was 100 mg/l. None of total of seven fish died after 96 h of exposure; no mortality was seen in the blank control. Other toxic effects than mortality, e.g. loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed (Häner, 2002)

REFERENCE

Huntingdon Research Centre, 1975. The acute toxicity of dyestuffs and auxiliary chemicals to rainbow trout (Salmo gairdneri). Date: October, 1975. Data owner: Archroma.