Sodium 2-[[4-(cyclohexylamino)-9,10-dihydro-9,10-dioxo-1-anthryl]amino]-5-ethoxybenzenesulphonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

January 22nd to March 22d, 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: laboratory culture originating from a strain supplied by I.R.CH.A., France.
- Breeding: testing laboratoyr, cultures maintained at 21°C in polypropylene vessels containing two litres of dechlorinated and aged tap water. Culture conditions ensure that reproduction is by part
henogenesis.
- Age of parental stock: gravid adults were isolated 24 hours prior to initiation of the test. Young daphnids produced overnight were used for testing.
- Feed: cultures were fed daily with a suspension of mixed algae (predominantly Chlorella spp.).

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

Start: 21 °C
End: 21 °C

pH:

Start: 7.4
End: 7.2

Dissolved oxygen:

Start: 8.7 mg O2/l
Start: 8.1 mg O2/l

Nominal and measured concentrations:

5.0, 9.0, 16, 28, 50, 90, 160, 280 and 500 mg active ingredient/l

Details on test conditions:

TEST SYSTEM
- Daphnia loading: according to test protocol.

TEST MEDIUM / WATER PARAMETERS
- Water quality characteristics: according to test protocol.

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

140 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Details on results:

EC0 (48h): 16 mg a.i./l (nominal)
EC100 (48h): 500 mg a.i./l (nominal)

Results with reference substance (positive control):

EC50 (24h): 1.5 mg/l

Cumulative immobilisation of daphnids (%) test item

Concentration (mg a.i./l)	24 hrs	48 hrs
Control	0	0
Test item 5.0	0	0
Test item 9.0	0	0
Test item 16	0	0
Test item 28	5	5
Test item 50	5	15
Test item 90	10	20
Test item 160	20	60
Test item 280	30	70
Test item 500	60	100

Immobilisation rate of daphnids (%) reference substance

Concentration (mg a.i./l)	24 hrs	48 hrs
Control	0	0
Reference substance 0.10	0	0
Reference substance 0.18	0	0
Reference substance 0.32	0	0
Reference substance 0.56	5	5
Reference substance 1.0	5	15
Reference substance 1.8	10	20
Reference substance 3.2	20	60
Reference substance 5.6	30	70
Reference substance 10	60	100

Conclusions:

EC50 (48h): 140 mg a.i./l (nominal)

Executive summary:

The acute toxicity of substance to Daphnia magna was investigated under static exposure conditions over a period of 48 hours, according to OECD guideline 202. The following concentrations were tested: 5.0, 9.0, 16, 28, 50, 90, 160, 280 and 500 mg active ingredient/l.

Potassium dichromate was also tested as reference substance.

The maximum concentration causing no immobilization after 48 hours was 16 mg a.i./l (nominal); on the contrary, at the concentration of 500 mg a.i./l all the test organisms resulted to be immobilized. The EC50 at 48 hours was determined to be 140 mg a.i./l.

Conclusion

EC50 (48h): 140 mg a.i./l (nominal)

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

From April 06th to September 27th, 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

part I, adopted 1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

September 19, 1984

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Test item was dissolved in the test medium at a concentration of 100 mg/100 ml (stock solution). Thereafter, series of sequential dilutions with the test medium were prepared to obtain the final test concentrations of the test article.

Test organisms (species):

Daphnia magna

Details on test organisms:

Animals were bred in the testing laboratory, under standardized conditions.
For the test, animals with an age of less than 24 hours were used.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Test temperature:

21.5 °C

pH:

Start: 8.4
End: 8.3

Dissolved oxygen:

Start: 8.6 mg/l
End: 9.0 mg/l

Nominal and measured concentrations:

Nominal 0, 1, 10 and 100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 ml beakers.
- Volume: beakers contain 20 ml of test medium.
- No. of organisms per vessel: 10 animals.
- No. of vessels per concentration: 2 replicates.
- No. of vessels per control: 2 replicates.

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: bidistilled water.
- Test medium: according to the Directive EEC.
- CaCl2 × 2H2O: 294 mg/l
- MgSO4 × 7H2O: 123 mg/l
- NaHCO3: 65 mg/l
- KCl: 5.8 mg/l.

OTHER TEST CONDITIONS
- Adjustment of pH:pH of reconstituted water was adjusted to 7.9 ± 0.3.
- Photoperiod: 16 hours of illumination.
- Light intensity: 1000 Lux.

EFFECT PARAMETERS MEASURED
Test evaluations were done according to the OECD guideline 202 by visual control of the mobility of the daphnids after 24 hours. Based on the data, an estimate of the EC0, 50 and 100 was given.

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No deaths occurred over the exposure period of 24 hours. EC0 (24h): 100 mg/l

Appearance of the test medium: blue solution.

Influence of test item on the immobilization of Daphnia magna, after 24 hours of exposure

Concentration (mg/l)	N. of daphnids	N. of responses	% of responses
Control	10	1	10
Control	10	0	0
Test item 1	10	0	0
Test item 1	10	0	0
Test item 10	10	0	0
Test item 10	10	0	0
Test item 100	10	0	0
Test item 100	10	0	0

Conclusions:

EC50 (24h) > 100 mg/l (nominal)

Executive summary:

The acute toxicity of the test substance to Daphnia magna was investigated over a period of 24 hours, following the OECD guideline 202, part I (1984). The nominal test concentrations applied were 0, 1, 10 and 100 mg/l; all tests were run in duplicate. No chemical analysis of the test substance concentration was conducted. No deaths occurred at the nominal concentration of 100 mg/l; 10 % of mortality was observed in one of the two blank controls. The EC0 was identified to be 100 mg/l. Test medium appeared to be blue solution.

Conclusion

EC50 (24h) > 100 mg/l (nominal)

Description of key information

EC50 (48h) > 100 mg/l

Additional information

There are no data about the short-term toxicity potential of Acid Blue 280 to aquatic invertebrates; therefore, available data on structural analogues Similar Substance 01 and Similar Substance 02 has been taken into consideration. The read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).

As both studies were reliable, the assessment was based on a weight of evidence approach.

The acute toxicity of the Similar Substance 01 to Daphnia magna was investigated over a period of 24 hours, following OECD guideline 202, part I (1984). The nominal test concentrations applied were 0, 1, 10 and 100 mg/l; all tests were run in duplicate. No chemical analysis of the test substance concentration was conducted. No deaths occurred at the nominal concentration of 100 mg/l; 10 % of mortality was observed in one of the two blank controls. The EC0 was identified to be 100 mg/l. Test medium appeared to be a blue solution.

The acute toxicity of Similar Substance 02 to Daphnia magna was investigated under static exposure conditions over a period of 48 hours, according to OECD guideline 202. The following concentrations were tested: 5.0, 9.0, 16, 28, 50, 90, 160, 280 and 500 mg active ingredient/l. The maximum concentration causing no immobilization after 48 hours was 16 mg a.i./l (nominal); on the contrary, at the concentration of 500 mg a.i./l all the test organisms resulted to be immobilized. The EC50 at 48 hours was determined to be 140 mg a.i./l.