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Diss Factsheets

Ecotoxicological information

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
no
Remarks:
Not GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate
EC Number:
304-762-8
EC Name:
Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate
Cas Number:
94279-16-0
Molecular formula:
C40H24N10Na4O19S4
IUPAC Name:
tetrasodium 4-[(1E)-2-{2,6-dihydroxy-3,5-bis[(1E)-2-{4-[(4-nitro-2-sulfonatophenyl)amino]phenyl}diazen-1-yl]phenyl}diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia Magna, Strauss (Cladocera, Crustacea)
TEST ORGANISM
- Strain:Daphnia Magna, Strauss (Cladocera, Crustacea)
- Source: Stirling University, UK
- Age at study initiation (mean and range, SD): <= 24h lifetime

ACCLIMATION
- Food type: Chlorella (freshwater algae) and marine algae extract
- Frequency: 3 times/week
-Temperature: 18-22°C
- Photoperiod: 16 light/8 darkness
- without areation
- Health during acclimation (any mortality observed): no

TEST period
-Temperature: 20 +/- 2°C
-Photoperiod: darkness

Study design

Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

pH:
7.73-7.95
Dissolved oxygen:
7.92-8.17 mg/l
Salinity:
CaCl2 2H2O= 11.76 mg/l
MgSO4 7H2O = 4.93 mg/l
NaHCO3= 2.59 mg/l
KCl= 0.23 mg/l

25 ml of each solution were added to 1000 ml deionised water
Nominal and measured concentrations:
0, 0.1, 1, 10 and 100 and 1000 mg/l of active ingredient (dye)
Details on test conditions:
TEST SYSTEM
- Test vessel: tubes of 40 ml sealed with parafilm
- Type (delete if not applicable): closed
- Aeration: no areation
- No. of organisms per vessel: 5 (for a total of 20)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control vehicle (replicates): 4

Reference substance (positive control):
yes
Remarks:
K2Cr2O7

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 31.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 17.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Results with reference substance (positive control):
- EC50/LC50: 24h, 0.86 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance was tested for acute toxicity on Daphnia (Immobilisation) following OECD 202. The tested sample under the experimental conditions showed an EC50,48h = 17.8 mg/l
Executive summary:

The substance was tested for acute toxicity on Daphnia (Immobilisation) following OECD 202. The test concentraions were 0.1, 1, 10, 100 and 1000 mg/l of dye for a total exposure of 48h. Vehicle and positive controls were also performed fulfilling validity criteria for the test. The tested sample under the experimental conditions showed an EC50,48h = 31.6 mg/l.

The substance showed toxic effects to daphnia and needs to be classified under Regulation 1272/2008 (CLP) as Aq. Chronic 3, H412.