Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate

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

Study period:

December from 4th to 8th, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The study described was conducted in accordance with SN EN 45001. No analytical determinations were conducted.

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)

Version / remarks:

adopted 31 July, 1992, published 29 December 1992

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Poecilia reticulata

Details on test organisms:

TEST ORGANISM
- Common name: Guppy.
- Length at study initiation: 1 - 3 cm
- Breeding: parental and young fish population was held in two 250 l glass aquaria. Illumination 14h a day and temperature of 23 ± 2 °C. The medium was continuously aerated and filtered tap water from Schlieren. The bottom of the aquaria was covered with gravel (<1.5 cm). Every month, one third of the total volume of the aquaria was replaced by fresh tap water.
- Feeding during test: fish were last fed 24 h before the start of the definitive test.
- Food type: sera micropan, Sera vipan (Sera apanristic GmbH, D-52525 Heinsberg, Germany) daily.
- Health during acclimation: during 7 days before the definitive test, mortality in the batch of which fish were used for the test was less than 5 %.

ACCLIMATION
- Acclimation period: to start the test fish were transferred into the test vessels about 1 h after formation of the test media.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

21 ± 1 °C

pH:

Control: 8.6 - 8.9
Test vessels: 7.5 - 8.8

Dissolved oxygen:

Control: 7.4 - 7.9 mg/l
Test vessels: 7.3 - 7.8 mg/l

Nominal and measured concentrations:

100 mg/l nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: 1 l aquaria, all-glass.
- Aeration: aerated.
- No. of organisms: 7 fish per test concentration.

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: tap water from Schlieren. At least 1 h before the test the test vessels were filled with the medium to allow equilibration of pH, oxygen and temperature.
- pH: 7.1 - 7.4
- Conductivitv (20 "C): 510 - 585 µS/cm
- CO3 Hardness: 15.3 - 27.8 °F
- CO3 Hardness after Heyer: 15.2 - 26.9 °F
- Rest Hardness: 2.4 - 4.1 °F
- Total Hardness: 17.7 - 31.9 °F
- KMnO4-consumotion: 1.0 - 1.3 mg/l
- E. Coli (at 44 °C): 0 % ml
- Colony count: 0 % per ml at 20 "C; 0- 5 % per ml at 30 °C.
- Chloride: 7.5 - 12.0 mg/l
- Sulfate: 17.5 - 21.0 mg/l
- Phosphate as PO4-P: <0.002 - 0.038 mg/l
- Ammonia as NH4-N: <0.01 mg/l
- Nitrite as NO2-N: <0.002 mg/l
- Nitrate as NO3-N: 7.0 - 12.0 mg/l

OTHER TEST CONDITIONS
- Adjustment of pH: none.
- Photoperiod: 16 h photoperiod a day, supplied by overhead white fluorescent tubes.

EFFECT PARAMETERS MEASURED
Fish were considered to be dead when they showed no reaction after touching the caudal fin or no visible breathing movements.
Based on the binominal theory, the absence of mortality of a total of seven fish provides at least 99 % confidence that the LC50 is greater than the applied nominal test concentration of 100 mg/|.

MEASUREMENTS
- Oxygen, pH, temperature: prior to the addition of fish to the test medium and after 2, 24, 48, 72 and 96 h of exposure.
- Observations: observations of the fish were made after 2, 24, 48, 72 and 96 h of exposure. Moftality of the fish was recorded at the same time intervals. Dead fish were removed immediately from the test medium and weight and length recorded.

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. 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 higer than 100 mg/l.

No mortality was also observed in the blank control.

Sublethal observations / clinical signs:

Data of surviving fish after termination of the test.

Nominal concentration (mg/l)
100	length (mm)	22	21	20	23	24	19	13
	weight (mg)	88	68	79	98	101	43	32

Validity criteria fulfilled:

not specified

Remarks:

no chemical analysis of the test substance concentration was conducted

Conclusions:

LC50 (96h) > 100 mg/l (nominal)

Executive summary:

The acute lethal toxicity of the test substance to Poecilia reticulata (Guppy) was investigated under static exposure conditions over a period of 96 hours, following the OECD guideline 203. 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 a total of seven fish died after 96 hours 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 higher than 100 mg/l.

Conclusion

LC50 (96h) > 100 mg/l (nominal)

Description of key information

LC50 (96h) > 100 mg/l (nominal)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The acute lethal toxicity of the test substance to fish was investigated under static exposure conditions over a period of 96 hours, following the OECD guideline 203. The only applied nominal test concentration was 100 mg/l. No mortality was also observed in the blank control. At the nominal concentration of 100 mg/l none of a total of seven fish died after 96 hours of exposure; other toxic effects than mortality, e.g. loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed, thus the No-Observed-Effect Concentration (NOEC) resulted to be higher than 100 mg/l.

Although no chemical analysis was conducted, the test item is expected to be stable under the tested conditions and over the exposure period: Acid Orange 067 does not undergo to a rapid biotic neither abiotic transformation processes, which may impact the stability during the test.

Data regarding an old test are also available and indicate a LC50 value at 48 hours of 100 mg/l. There are no details on testing method and procedures followed; only the sheet of results is available (reference into CSR).