2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3-acetyloxy-2,2-dimethylpropyl) acetate

EC Number:

826-122-1

Cas Number:

13431-57-7

Molecular formula:

C9 H16 O4

IUPAC Name:

(3-acetyloxy-2,2-dimethylpropyl) acetate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BSCL20180222-2105

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
- Water Solubility: 814 mg/L (20°C, pH 5.8)
- The test item was a clear colorless apparently homogeneous liquid.

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A certain amount of test substance was added in a certain volume of test water and stirred (via magnetic stirrer) in the dark for l h (the vortex depth was 1/3 of that of the mixture column) until it dissolved, to prepare a stock solution with a nominal concentration of 120 mg/L. The test solutions were prepared by dilution of the stock solution with test water. The frequency of the renewal of the stock solution and the test solutions were both 48h during the definitive test.

Test organisms

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

TEST ORGANISM
The test was performed with Gobiocypris rarus which were bred in Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement (ID:GR-SAPM-180423).

ACCLIMATION
Before being used in the test, all fish were acclimatized in the following test conditions for more than 14 days:
Water: the test water used was tap water dechlorinated by activated carbon and sterilized by UV lamp;
Temperature: 21-25tC and constant within a range of 2C.
pH: 6.0-8.5;
Dissolved oxygen concentration: > 80% of air saturation value (ASV);
Photoperiad: Lightioark = 12 hours/12 hours;
Feeding: fish were fed with brine shrimp flake (O.S.l, USA) daily until 24 hours before the test was started.
Length was 2.4 ± 0.1 cm (Mean ± SD) and weight was 0.27±0.01 g (Mean ± SD) at the end of the test. The age of the test fish was approximately seven months old, before the test they were not medically treated.

FEEDING DURING TEST : none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

21.7 °C - 23.7 °C

pH:

6.0 - 8.5

Dissolved oxygen:

61.3% - 98.9%

Nominal and measured concentrations:

Nominal: 0, 42 mg/L, 55 mg/L, 71 mg/L, 92 mg/L and 120 mg/L
Measured: 0, 38.1 mg/L, 50.4 mg/L, 67.1 mg/L, 91.0 mg/L and 115 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10L glass vessels with seals containing 9 L test solution
Loading rate: about 0.2g fish/litre
Aeration: no
- Renewal rate of test solution (frequency/flow rate): 48h

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp, was used. The water was aerated continuously over 24h.

OTHER TEST CONDITIONS
- Light intensity: 16 hours photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
At 3, 24, 48, 72 and 96 h, the mortalities of the fish were recorded, and observations on individual behaviour were performed. Meanwhile, measurements of pH, dissolved oxygen and temperature were carried out and recorded daily.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

96 d

Dose descriptor:

LC50

Effect conc.:

74.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The maximum mean measured concentration causing no mortality and the minimum mean measured concentration causing 100 percent mortality within the period of the test was 50.4 mg/L and 91.0 mgIL, respectively. The results above were expressed relative to the geometric means of the measured concentrations.

Reported statistics and error estimates:

The mortalities were plotted against each test concentration (geometric mean measured) and control for each exposure period (24h, 48h, 72h and 96h). The 24, 48 and 72 hours LC50 were calculated using the method of Linear Interpolation. The 96 hours LC50 with 95% confidence limits were calculated using the method of Spearman-Karber. The data analysis was carried out with software TOXCALO-Toxicity Data Analysis Software (v5.0.32).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 96h LC50 value for Pyranyl acetate to Gobiocypris rarus was 74.9 mgIL and 95 percent confidence limits ranged from 69.3 mg/L to 81.0 mg/L.
No mortality was observed in the control during the test. Acceptable exposure conditions were maintained throughout the test. The dissolved oxygen concentrations in test solutions were between 61.3%- 98.9%ASV, which was greater than 60.0% of the air saturation value, throughout the test. During the test, the measured concentrations of the test substance in each group varied less than 20% during each renewal period (-7.25%-(-0.766%)), even those of the freshly prepared solutions varied within ± 20% of their arithmetic mean measured one (-0.963%-0.963%).
The test fulfilled the above requirements and was therefore considered to be valid.