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 aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13. Nov. 1991 to 05. Mar 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: UBA-Recommendation §4 Abs 1 Nr 6

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 320, 560, 1000 mg/L
- Sampling times: begin and end of the study from each test vessel
- Sample size: ca. 10 mL
- Sample storage conditions before analysis: NA

Vehicle:

no

Details on test solutions:

The test substance was directly weighed into the test vessels and homeneneously diluted with dilution water adjusted to pH 6 to prevent the disintegration of the TS to the oxy-dye (Oxyfarbstoff) by means of an ultra sonic sound.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Species: Daphnia magna STRAUS
- Source: Hoechst AG Kastengrund
- Method of breeding: in a 100 mL beaker glass (90 mm x 50 mm) filled with 70 mL dilution water (modified freshwater according to Elendt). One Daphnia was inocculated into each vessel. Animals were used for breeding until 42 days of age. Reproduction rate and health status was recorded once on weekdays.
- Food type: Scenedesmus subspicatus
- Amount: depending on age (0.3 to 1.6 mg/L CSB)
- Frequency: trice per week

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

NA

Hardness:

measured once a week in the dilution water

Test temperature:

control: 21 to 21.9 °C
test groups: 20.9 to 21.9 °C

pH:

dilution water adjusted to pH 6
measured values:
control: 6 to 7.1
test groups: 5.9 to 7.2

Dissolved oxygen:

control: 8.5 to 9.1 mg/L
test groups: 8.3 to 8.9 mg/L

Nominal and measured concentrations:

Nominal: 0, 320, 560, 1000 mg/L
Measured:
Control: nothing detected
320 mg/L: 0 h: Day1: 323 mg/L Day 2: 295 mg/L
24 h: Day 1: 300 mg/L Day 2: 273 mg/L
560 mg/L: 0 h: Day 1: 537 mg/L Day 2: 610 mg/L
24 h: Day 1: 511 mg/L Day 2: 521 mg/L
1000 mg/L: 0 h: Day 1: 1035 mg/L Day 2: 864 mg/L
24 h: Day 1: 963 mg/L Day 2: 1027 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: 250 mL beeker glass
- Material, size, headspace, fill volume: glass, 110 mm x 70 mm, filled with 200 mL test water
- Aeration: dilution water was saturated with oxygen prior to study start
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): NA


TEST MEDIUM / WATER PARAMETERS (see attachment)
- Source/preparation of dilution water: modified freshwater according to Elendt
- Intervals of water quality measurement: after addition of TS and at study end


OTHER TEST CONDITIONS
- Adjustment of pH: 6
- Photoperiod: 12/12
- Light intensity: illumination with fluorescent lamp


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility rate

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca 1.8
- Range finding study: yes

Reference substance (positive control):

not required

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

560 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

748 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

1 000 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Details on results:

In a test vessel of the 320 mg/L group, a 100 % immobilisation rate was observed. Because in the second test vessel of this group and in the 560 mg/L groups no immobility appeared, this effect was not considered in the result.

Validity criteria fulfilled:

yes

Conclusions:

The EC50 of the test item in Daphnia magna after 48 hours is determined to be 748 mg/L

Executive summary:

In a GLP-compliant 48 h acute toxicity test, the test substance was assessed according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test); and EU Method C.2 (Acute Toxicity for Daphnia).

Daphnia magna were exposed to the test substance at concentrations of 320, 560 and 1000 mg/l and observed at 24 and 48 h for mobility.

The EC50 of the test item in Daphnia magna after 48 hours is determined to be 748 mg/L

Description of key information

The EC50 of the test substance is >100 mg/l. Hence, the test substance is not toxic to aquatic invertebrates as tested on Daphnia magna.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

In a GLP-compliant 48 h acute toxicity test, the test substance was assessed according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test); and EU Method C.2 (Acute Toxicity for Daphnia). Daphnia magna were exposed to the test substance at concentrations of 320, 560 and 1000 mg/l and observed at 24 and 48 h for mobility. The EC50 of the test item in Daphnia magna after 48 hours is determined to be 748 mg/L.

In a publication from Ministry of the Environment Government of Japan, 48 h acute toxicity test with test substance was assessed according to OECD Guideline 202. Daphnia magna were exposed to the test substance at concentrations of 1,000, 316, 100, 31.6, 10.0, 3.16, 1.00 mg/L and observed at 24 and 48 h for mobility. The EC50 of the test item in Daphnia magna after 48 hours is determined to be >1000 mg/L.

In other support studies which were performed following a method similar to according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) EC50 value of 72.9 mg/L, and 750 mg/L were observed.

 

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 202 guideline in compliance to GLP is taken into consideration here to analyze the toxicity of the test substance. The EC50 of the read across substance in Daphnia magna after 48 hours was noted to be above 128 mg/L

 

Taking data from above mentioned key and supporting studies into account and also the data from the read-across substance, the EC50 of the test substance to Daphnia magna is >100 mg/l. Hence, not toxic to aquatic invertebrates Daphnia magna.