Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no analytical verification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
231-494-8
EC Name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7585-41-3
Molecular formula:
C18H13ClN2O6S.Ba
IUPAC Name:
barium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1.00 g test substance were added to 10 L test water and the mixture was homogenized with an ultra-turrax stirrer. Since the test substance was sparingly soluble in water, the test concentration was prepared 1 day before the test organisms were introduced into the test vessel (study start) and stirred during this time, to ensure that saturated concentration was used.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: breed in testing facility
- Age at study initiation: about 7 months
- Length at study initiation: 3.6 (3.4 - 3.7) cm
- Weight at study initiation: 0.54 (0.43 - 0.63) g
- Food type: Standard feed (TETRA MIN), on workdays generally additionally live artemia
- Amount: ad libitum

ACCLIMATION
- Conditions equivalent to housing
- Health during acclimation (any mortality observed): 0 % mortality during the last 7 days prior to test initiation

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
- Total hardness: about 2.5 mM (about 250 mg/L CaCO3)
- Acid capacity: about 5.5 mM
Test temperature:
22 - 23 °C
pH:
8.1 - 8.2
Dissolved oxygen:
8.4 - 8.5 mg/L
Nominal and measured concentrations:
The following nominal concentration were tested: 0, 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel type: open
- Material, size, headspace, fill volume: all-glass aquaria, 30 x 22 x 24 cm, 10 L fill volume (water depth about 17 cm)
- Aeration: slight
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: ca. 0.5 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Municipal water of the city of Frankenthal, not chlorinated, char coal filtered
- Ca/Mg ratio: 9:1
- Intervals of water quality measurement: after 1, 24, 48, 72 and 96 hours

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light : 8 hours dark

EFFECT PARAMETERS MEASURED: mortality and symptoms

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: no effects observed up to the limit of water solubility.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
With high probability acutely not toxic to fish.