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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 12th 1999-30th November 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed under GLP according to OECD Guideline, validity criteria met.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. QA statement)
Remarks:
Statement of compliance

Test material

Constituent 1
Chemical structure
Reference substance name:
(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
EC Number:
201-210-7
EC Name:
(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
Cas Number:
79-50-5
Molecular formula:
C6H10O3
IUPAC Name:
(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
Details on test material:
- Name of test material (as cited in study report): LD-Lactone
- Physical state: White crystalline mass
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- During the limit test samples were taken from 100 mgll and the blank-control for analysis.
- Sampling frequency: at t= 0 h from freshly prepared solutions and at t= 24 h from the freshly prepared solutions and the 24h-old solutions.
- Volume: 10 ml from the approximate centre of the test vessels.
- Storage: Not applicable, samples were analysed on the day of sampling.
- Additionally, reserve samples of 10 ml were taken. These samples were stored in a deep-freeze until delivery of the final report with a maximum of
three months, pending on the decision of the sponsor for additional analysis. The method of analysis is described in the appended Analytical Report.

Test solutions

Vehicle:
no
Details on test solutions:
The standard test procedures required generation of test solutions which contain completely
dissolved test substance concentrations or stable and homogeneous mixtures or dispersions.
The testing of concentrations that disturbed the test system were prevented (e.g. film of the test
substance on the water surface).
DL-LACTONE was completely soluble in test medium at the concentrations tested. DLLACTONE
proved to be unstable in water at pH values of 7 and 9 in a hydrolysis test performed
at NOTOX (Project 257568). Therefore it was decided to perform the complete project under
semi-static test conditions with daily renewal of test solutions.
Daily, preparation of test solutions started with stock solutions prepared at 100 mg/L. No special
treatment other than careful mixing was necessary to dissolve the test substance in the test
medium. The lower test concentrations for the range-finding test were prepared by subsequent
dilutions of one of the stocks in test medium. Volumes of 80 ml (range-finding test) or 160 ml
(limit test) were taken and used for testing with Daphnia (NOTOX Project 257581). All final test
solutions were clear and colourless.

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) (Linnaeus, 1758)
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
- Mean length:Range-finding test: 3.3 A 0.1 9 cm, Final test: 2.88 st 0.21 cm
- Mean weight: Range-finding test: 1.25 k 0.1 7 g, Final test: 0.68 * 0.1 4 g
- Characteristics: F1 from a single parent-pair bred in UV-treated water.
- Reason for selection: This system has been selected as an internationally accepted species.
- Total fish used: 26

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
not applicable

Test conditions

Hardness:
Hardness of the medium: 250 mg CaC03/l
Test temperature:
The temperature in the test media and the control ranged from 20.1 to 21.9 °C
pH:
The pH values in the test media and the control ranged from 7.8 to 8.1
Dissolved oxygen:
The oxygen concentrations in the test media and the control ranged from 6.4 to 9.1 (always higher than 60% oxygen saturation)
Salinity:
No data
Nominal and measured concentrations:
Analysis of the samples taken during the limit test showed that the measured concentration was 144 mg/L in the freshly prepared 100 mg/L test
solution. An extra sample was analysed at t=O to check whether the high recovery was correct. The measured concentration in the reserve
sample was 140 mgll. The measured concentration after 24 hours was 145 mgll. Hence, thetest solution remained stable during the first 24-hour
renewal period. Preparation of test solutions proved to be repeatable as the concentration measured in the freshly prepared 100 mg/L solution
after 24 hours of exposure was 138 mg/L. In conclusion: the average exposure concentration during the study was approximately 140 mg/L.
Details on test conditions:
- Test duration: 96 hours
- Test type: Semi-static
- Test vessels: 10 litres, all-glass.
- Test medium: ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilized. After aeration the
- Hardness was 250 mg CaC03 per litre and the pH ranged between 7.9 and 8.0
- Number of fish: 7 fish per concentration and control
- Loading: 0.79 g fish / litre, i.e. 7 fish per 6 litres of test medium
- Illumination: 16 hours photoperiod daily
- Aeration: The test media were not aerated during the test
- Feeding: No feeding from 48 hours prior to the test and during the total test period
- Introduction of fish: Directly after preparation of the test media
- Euthanasia: At the end of the test the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 140 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: no
Results with reference substance (positive control):
Not relevant

Any other information on results incl. tables

Sublethal observations / clinical signs:

Under the conditions of the present test DL-LACTONE induced no visible effects in carp at or

below 100 mg/L, corresponding with an average measured concentration of 140 mg/L.

Hence, the 96h-LC50 was above 140 mg/L, the maximum concentration tested.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96h-LC50 of DL-Lactone is above 140 mg/L.
Executive summary:

96-Hour Acute Toxicity Study in carp with DL-LACTONE.

The study procedures described in this report were based on the EEC directive 92/69; Part C:

methods for the determination of ecotoxicity, Publication No. L383, December 1992, C.1. "Acute toxicity for fish", and the OECD guideline No. 203: "Fish Acute Toxicity Test", Adopted 17 July, 1992.

DL-LACTONE was completely soluble in test medium at the concentrations tested. The complete project was performed under semi-static test conditions with daily renewal of test solutions as DL-LACTONE proved to be unstable in water at pH values of 7 and 9 in the hydrolysis test performed at NOTOX (Project 257568).

The project started with a range-finding study. No effects on fish were observed up to and including a concentration of 100 mg/L. Hence, the project was continued with a limit study exposing seven carp per concentration to a concentration of 100 mg/L and a blank-control.

Samples for analysis were taken at the start and after 24 hours of exposure from the freshly prepared and 24-hour old test solutions.

Analysis of the samples taken during the limit test showed that the measured concentration remained within a 20% window during the 24-hour periods between refreshment. The average measured concentration corresponded with approximately 140 mg/L.

DL-LACTONE induced no visible effects in carp at or below 100 mg/L, corresponding with an average measured concentration of 140 mg/L. Hence, the 96h-LC, was above 140 mg/L, the maximum concentration tested.