Coupling reaction products of 3,3’-dichlorobiphenyl-4,4’-bis(diazonium) dichloride with N-(2,4-dialkylphenyl)-3-oxobutanamide and potassium 4-[(3-oxobutanoyl)amino]substituted benzene and their basic aluminium and earth alkali metal salts

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 December 2007 - 6 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Fish, Acute Toxicity Test stipulated in the "Testing Methods for New Chemical Substances" (November 21, 2003; No. 1121002, MHLW; November 13, 2003, No. 2, METI; No. 031121002, MOE, Japan)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): S-500
- Substance type: yellow powder
- Physical state: solid
- Lot/batch No.: MF1456-2345
- Stability under test conditions: stable (confirmed by IR)
- Storage condition of test material: dark storage place at room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control and 100 mg/l (nominal)
- Sampling method: Equal volume for analysis was taken out from the middle layer of the test solution for each vessel and mixed. This was done at the start of exposure, before and after the renewal and the end of exposure.
- Sample storage conditions before analysis: not applicable

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: mixing and stirring by magnetic stirrer for 48 h.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): suspension with floating material

Test organisms

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Medaka
- Strain: not indicated
- Source: Kurume Laboratory, Fukuoka, Japan
- Age at study initiation (mean and range, SD): 4 months of age
- Length at study initiation (length definition, mean, range and SD): 2.3 +/- 1.2 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 35 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: feed mixture for carp (2C)
- Health during acclimation (any mortality observed): no mortality during the 7 days before the start of the test

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No.

Test conditions

Hardness:

37 mg CaCO3/l

Test temperature:

23.7 - 24.2 °C

pH:

7.8 - 8.0

Dissolved oxygen:

8.0 - 8.2 mg O2/l

Nominal and measured concentrations:

Nominal 100 mg/l:
peak 1 not detected (< 0.000071 mg/l),
peak 2 not detected (<0.00031 mg/l),
peak 3 not detected at the start of the test and before/after renewal (<0.0024 mg/l), but 0.0034 mg/l at end of test
peak 4 not detected (<0.0045 mg/l)
Test item (i.e. sum of 4 peaks) not detected (<0.0073 mg/l).

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed with lid
- Material, size, headspace, fill volume: 3 L glass tank (16 cm diameter, 17 cm depth). Fill volume: 2.5 L.
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): after 48 h
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: <0.1 mg/l
- Particulate matter: <1 mg/l
- Pesticides: <0.0001 mg/l each
- Chlorine: <0.02 mg/l
- Alkalinity: 29 mg/l
- Ca/mg ratio: 10.3 / 2.8
- Conductivity: 15.5 mS/m
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: artificial light of white fluorescent lamp

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50 and LL50

Reference substance (positive control):

yes

Remarks:

copper sulphate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: effect concentration > solubility of test item in dilution water

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none observed
- Observations on body length and weight: body length 2.6-2.8 cm and body weight 0.13 - 0.18 g.
- Mortality of control: no mortality
- Effect concentrations exceeding solubility of substance in test medium: no effects observed above the water solubility of the test substance.

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Mortality: yes
- LC50: 96-h LC50 0.54 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study was conducted as a limit test in order to confirm the effect of the test item on the test organisms at around the solubility of the test item in dilution water. As a result, the concentration of the test item in the test solution during the exposure was below the determination limit (<0.0073 mg/L), therefore, results based on the quantified concentration of the test item could not be evaluated. it was concluded that the test item did not have an acute effect on the test organisms at around the solubility of the test item in dilution water because no adverse effect for test organisms was observed in above conditions. In addition, as the environmental conditions were also within the suitable range, it was evaluated that the study complied with the test guidelines.