Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 June - 29 June 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP, test substance present throughout test

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
other: ISO 7346-1
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 9580
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 99%
- Expiration date of the lot/batch: 31 Dec 2007
- Stability under test conditions: Not completely soluble in test medium at a loading rate of 100 mg/L. Reacts slowly with oxygen, e.g. in the presence of moisture, resulting in acid fluorides, carboxylic acids and HF. Exposure to air was kept at a minimum during the preparation procedures, since the test substance was indicated to be volatile.
- Storage condition of test material: At room temperature in the dark under nitrogen

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Exposure to air was kept at a minimum during the preparation procedures, since MV 31 was indicated to be volatile. An aqueous mixture was prepared by direct addition to the test vessels at a loading rate of 100 mg/L and then stirred for 15 minutes. After stirring, the mixture was observed to be colourless with small test substance droplets on the bottom of the vessel. The mixture was tested as such together with a control.

- Controls: Blank only
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Small droplets of MV 31 were observed on the bottom of the test chambers. Test solutions were used as such.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Hubrecht lab, Utrecht, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.8 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.43 ± 0.10 g
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): Temperature of culture medium was: 23.5 °C. Fish were acclimatized to 21.9 °C before the start of the test
- Type and amount of food: pelleted fish food (Nutra 3.0 T, TROUW NUTRITION, Putten, The Netherlands)
- Feeding frequency: Daily until 24 hours before the test is started
- Health during acclimation (any mortality observed): <5%

Study design

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

Test conditions

Hardness:
180 mg CaCO3 per litre
Test temperature:
21.4 - 22.1 °C
pH:
7.4 - 8.0
Dissolved oxygen:
6.2 - 9.2
Salinity:
N/A
Nominal and measured concentrations:
Nominal concentrations only: 0 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Air-tight 10 L all-glass containers.
- Material, size, headspace, fill volume: 9.5 L test solution, ca. 0.5 L headspace.
- Aeration: none
- No. of organisms per vessel: seven
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.32 g fish / litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, formulated using tap-water purified by reverse osmosis.
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours daily
- Light intensity: Not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, severe distress, examined at 2, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish.
Reference substance (positive control):
yes
Remarks:
pentachlorophenol, within one week of test.

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
Remarks on result:
other: no mortality or other clinical effects were observed during test period.
Details on results:
- Behavioural abnormalities: None noted
- Observations on body length and weight: Endpoints not specified
- Other biological observations: None noted
- Mortality of control: None
- Other adverse effects control: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Undissolved MV 31 seen in test solutions
Results with reference substance (positive control):
The LC50 for pentachlorophenol was 0.22 mg/L in a test conducted within one week of the MV 31 test. The pentachlorophenol historical LC50 range for this laboratory is 0.10 - 0.46 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
no mortality in controls, constant conditions maintained as practicable, DO > 60% of saturation, test substance maintained in chambers.
Conclusions:
LC50 of MV 31 to D. rerio was >100 mg/L nominal concentration (EC method C.1)
Executive summary:

Toxicity of MV 31 to fish was assessed in a limit test under EC method C.1 and OECD TG 203 using D. rerio (zebrafish). A test chamber with a nominal loading rate of 100 mg/L was prepared by stirring to disperse the test substance. Small droplets of MV 31 were observed on the bottom of the vessels throughout the test. Test solutions were used as such. No mortality or other clinical signs were seen in either control or MV 31-treated test chambers. Because undissolved MV 31was seen throughout the test and the material was well above its solubility limit, fish were assumed to be exposed to MV 31 at saturation levels throughout the test. LC50 of MV 31 to D. rerio was >100 mg/L based on nominal concentration.

The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.

Test Type: Static

96-h LC50: >100 mg/L (nominal)