Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-09 - 2002-08-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)
Remarks:
2000-04-26

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
In an attempt to determine a dosing method that would achieve near nominal test concentrations a preliminary dosing trial with chemical analysis was performed at a test concentration of 100 mg/L using dynamic, continuous flow test conditions. Analysis of the 100 mg/L test concentration at 0 and 24 hours gave measured test concentrations of 96% and 111% of nominal respectively. Therefore dynamic, continuous flow test conditions were shown to be appropriate for the preparation of the test media for the definitive test.

The concentration and stability of the test material in the test preparations were verified by chemical analysis at 0, 24, 48, 72 and 96 hours.

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, UK
- Length at study end (length definition, mean, range and SD): 4.8 cm (sd = 0.3)
- Weight at study end (mean and range, SD): 1.51 g (sd = 0.34)

ACCLIMATION
- Acclimation period: 13 days
- Acclimation conditions: Same as test conditions
- Type and amount of food during acclimation: fed commercial trout pellets

FEEDING DURING TEST
No food during the test (supply was stopped about 48 hours before the test)

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
119 mg/L as CaCO3
Test temperature:
14 °C
Conductivity:
427 µS
Nominal and measured concentrations:
Range-finding: 100 mg/L
Definitive test: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 20L vessel
- Type: closed
- Aeration: The test vessels received no auxiliary aeration; the diluent supply only was aerated.
- Type of flow-through: peristaltic pump
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test water used for both the range-finding and definitive tests was laboratory tap water dechlorinated by passage through an activated carbon filter and partly softened giving water with a total hardness of approximately 100 mg/L as CaCO3. After dechlorination and softening the water was then passed through a series of computer controlled plate heat exchangers to achieve the required temperature.
- Total organic carbon: 1.8 mg C/L
- Particulate matter: 0.3 mg/L
- Alkalinity: 92.4 mg/L as CaCO3

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours dark; 20 minute dawn and dusk transition periods

TEST CONCENTRATIONS
Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality and no sub-lethal effects observed during the range-finding test at 100 mg/L.

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There were no mortalities in 30 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. There were also no sub-lethal effects.

Analysis of the test preparations at 0h showed measured test concentrations to range from 90 to 135% of nominal and at 24, 48, 72 and 96 hours measured test concentrations ranged from 100 to 115% of nominal. It was therefore considered justifiable to estimate the LC50 values in terms of nominal test concentrations only.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave 96-hour LC50 of greater than 100 mg/L. Correspondingly, the NOEC was 100 mg/L
Executive summary:

The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated following the OECD TG 203 and under GLP conditions. The 96-hour LC50 was greater than 100 mg/L. Correspondingly, the NOEC was 100 mg/L.