Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-05-16 to 1990-08-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed under the appropriate guideline during that time. The EC-50 results reported are referring to a testing time of 24 hours, whereas the new guideline requests to report data after 48 hours of exposure of daphnia to the test item. ECHA's endpoint specific guidance, chapter R.7B 8p49) says "...Invertebrates: ...standard testing data might be substituted by... a 24 hour EC50 value from short-term toxicity testing on Daphnia sp. according to OECD 202, but this should only be used in conjunction with other data (e.g. on time-dependence of toxicity) as part of a Weight of Evidence approach." Considering the overall quality of the study and consistency of the data obtained, and since the results from the test item at 24 hours can be compared with 24-hours toxicity data from the positive control substance, the study is considered as a Klimisch-2 study with acceptable restrictions, which eventually can qualify the study as a key study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted April 4, 1984

Deviations:

yes

Remarks:

During that time OECD 202 requested to report EC50 after 24 hours, instead of EC50 48 hours as requested in the new version of OECD 202.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

adopted September 19, 1984

Deviations:

yes

Remarks:

EC50 after 24 hours is being reported

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

EC Number:

407-230-4

EC Name:

Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)

Cas Number:

126637-70-5

Molecular formula:

Hill formula: C32 H16 Cu2 Li2 N6 Na2 O16 S4 CAS formula: C32 H16 Cu2 N6 O16 S4. 2Li 2Na

IUPAC Name:

dicopper(2+) dilithium(1+) disodium 4,4'-bis[2-(8-amino-1-oxido-3,6-disulfonatonaphthalen-2-yl)diazen-1-yl]-[1,1'-biphenyl]-3,3'-bis(olate)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

according to guideline

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Remarks on exposure duration:

appropriate testing time for the OCED 202 version at that time

Post exposure observation period:

not applicable

Test conditions

Hardness:

11.8 °DH

Test temperature:

18 - 22 °C

pH:

DSW: pH 8.2 1/- 0.2 after aeration
test batches: pH 8.2 - 8.9

Dissolved oxygen:

9.1 - 11.5 mg/l

Salinity:

Not being reported as such, however the detailed mineral composition of the used so-called "Dutch standard water" (DSW) is given in the original study report.

Nominal and measured concentrations:

Measured concentration varied between 93 and 106 % of the nominal concentrations of the test item (see study on acute fish toxicity conducted in parallel by Boger 1990).

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 ml , all-glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: all-glass, 250 ml, 150 ml, 100 ml
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-thru design applied
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 10 per 100 ml medium
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not reported

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

289 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

including mortality

Remarks on result:

other: 95% CL: 215 - 530 mg/l

Effect concentrations 2

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

including mortality

Reported statistics and error estimates:

The EC5O-value at 24 of exposure was calculated from the probits of the percentages of affected daphnia and the logarithms of the corresponding nominal concentrations using the maximum likelihood estimation method (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 24h-EC50 of the substance was 289 mg/l with 95% confidence interval ranging from 215 to 530 mg/l. The No Observed Effect Concentration for the registered substance with respect to mobility of Daphnia magna was found to be 18 mg/l after 24 hours of exposure.