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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
18.04.2011 to 23.04.2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study conducted as a limit test

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1)
EC Number:
700-567-0
Cas Number:
1231728-34-9
Molecular formula:
C18H34O4Sn
IUPAC Name:
Hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1)
Test material form:
liquid: viscous

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The dilution water (control) and the test substance preparation of nominal 100 mg/L dilution water were determined by DOC analysis. For this purpose the samples were filtered through a cellulose nitrate membrane filter. 10 mL (5 mL for TIC analysis) filtrate of the test substance preparation and the control were filled into the measuring vessel and firmly closed. Then, they were placed in the sampling unit and measured automatically as triplicate determination with the TC and TIC analyser.

Test solutions

Vehicle:
no
Details on test solutions:
1050 mg/L were added to 10.5 L dilution water (=100 mg/L) and stirred for 24 h. Afterwards the test substance preparation was filtered through a filter paper.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: Hamilton-Buchanan
- Source: Raiffeisenmarkt, 47906 Kempen (Germany)
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): 2 +/- 1 cm
- Weight at study initiation (mean and range, SD): not reported
- Method of breeding: The zebra fish were held in glass tanks of 300 L, sealed with silicone. Illumination was run automatically in a 12/12 hours light/dark cxcle. Oxygen was supplied by compressed oil free air so that oxygen saturation was at least 80% of the air saturation level. Temperature was adjusted to 21-25°C. Feeding with Tetra Min took place five times a week.
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): yes
- Type and amount of food: the fish were fed with Tetra Min (amount not reported)
- Feeding frequency: five times a week
- Health during acclimation (any mortality observed): Following a 48-h acclimatisation period after delivery of the fish, mortalities were recorded and the following criteria applied
- mortalities >10% of population in seven days: rejection of entire batch
- mortalities between 5 and 10% of population in seven days: acclimatisation continued for seven additioal days
- mortalities <5% of population: acceptance of batch

Study design

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

Test conditions

Hardness:
1.881 mmol/L (dilution water)
Test temperature:
control: 21.5-22.7°C during the test
test sample: 21.4-22.4°C during the test
pH:
control: 8.06-8.42 during the test
test sample: 7.74-8.22 during the test
Dissolved oxygen:
control: 80-90% during the test
test sample: 83-89% during the test
Nominal and measured concentrations:
100 mg/L nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): not reported
- Material, size, headspace, fill volume: glass/15 L/-/-
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): no vehicle used
- Biomass loading rate: <=1.0 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Holding and dilution water were prepared by mixing demineralised water with de-chlorinated tap water from municipal source in a ratio of 3:2 and sulfuric acid
- Alkalinity: 1.076 mmol/L
- Ca/Mg ratio: 4:1
- Conductivity: 375 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: once a year sodium, potassium and alkalinity were determined

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 h light/dark cycle
- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms of toxicity
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
behaviour

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance preparation of nominal 100 mg/L induced neither mortality nor symptoms of toxicity in Danio rerio (96 h NOEC >=100 mg/L; 96 h LC50>100 mg/L nominal).
Executive summary:

The toxicity of hexanoic acid, 3,5,5 -trimethyl-, tin (2 +) salt (2.!) was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test) and EU Method C.1 (Acute Toxicity for Fish). In this limit test, fish (Danio rerio) were exposed to a nominal test substance concentration of 100 mg/L over a period of 96 h under static conditions. As the test substance was poorly water soluble a water accommodated fraction was prepared (dissolving of test substance in dilution water, stirring for 24 h, filtration). DOC analysis showed that no loss of substance occurred during the exposure period (DOC recovery: 106 -126% after 24, 48, 72, and 96 h). At the concentration tested neither mortality nor symptoms of toxicity were observed (96 h NOEC>=100 mg/L; 96 h LC50>100 mg/L nominal).

The study is regared as reliable with restrictions (only one concentration was tested) and satiesfies the requirements of the guideline.

Synopsis

Test organism/length: Danio rerio/2 +/-1 cm

Test type: static

96 h NOEC: >=100 mg/L

96 h LC50>100 mg/L (values refer to nominal concentrations)

Endpoint(s) affected: mortality, symptoms of toxicity