Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(o-nitrophenyl)azo]-p-cresol
EC Number:
215-863-0
EC Name:
2-[(o-nitrophenyl)azo]-p-cresol
Cas Number:
1435-71-8
Molecular formula:
C13H11N3O3
IUPAC Name:
4-methyl-2-[(2-nitrophenyl)diazenyl]phenol
Details on test material:
- Name of test material (as cited in study report): TKA 40136, Monoazo 3113
- Physical state: Red-brownish solid
- Analytical purity: > 95%
- Lot/batch No.: Pa 369
- Storage condition of test material: At room temperature in the dark
- Expiry date: 1997-11-1

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling: During the final test duplicate samples were taken from 0 mg/L, 10 mg/L and the acetone-control for analysis. Sampling frequency: At t= 0 h and at t= 24 h (10 ml from the approx. centre of the test vessels).
- Storage: The samples were stored in a deep-freeze.

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Acetone was used as a presolvent to prepare stock solutions.
- Chemical name of vehicle: Acetone
- Concentration of vehicle in test medium: 0.117 mL/L
- Evidence of undissolved material: Yes

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, The Netherlands
- Length at study initiation: Range-finding test: 2.91 ± 0.26 cm, final study: 2.75 ± 0.34 cm
- Weight at study initiation: Range-finding test: 0.74 ± 0.17 g , final study: 0.76 ± 0.21 g
- Feeding during test: No feeding 24 hours prior to the test and during the total test period.

ACCLIMATION
- Acclimation period: At least 12 days
- Type of food: Daily feeding with Trouvit and Artemia
- Mortality: < 5%

Study design

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

Test conditions

Hardness:
250 mg/L CaCO3
Test temperature:
20.2-20.6 °C
pH:
8.1
Dissolved oxygen:
7.1-9.6 mg/L
Nominal and measured concentrations:
Nominal: 10 mg/L
Measured:
Spectrophotometric method: 0.58-8.7 mg/L
HPLC method: 1.3-6.3 mg/L

Details on test conditions:
TEST SYSTEM
- Test vessel: 8 liter glass vessels
- Renewal rate of test solution: Every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- No. of vessels per vehicle control: 1
- Biomass loading rate: 0.89 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Photoperiod: 16h daily

EFFECT PARAMETERS MEASURED: Mortality

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1, 1.0 and 10 mg/L
- Results used to determine the conditions for the definitive study: No mortality observed in the highest concentration
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: 0
- Any observations that might cause a difference between measured and nominal values: Precipitation led to a significant decrease of the desired concentration.
- Effect concentrations exceeding solubility of substance in test medium: Yes
Results with reference substance (positive control):
- LC50 = 0.26 mg/L

Applicant's summary and conclusion

Conclusions:
The measured concentrations were clearly lower than the nominal concentration and the LC50 value exceeds the water solubility of the tested substance.