2-Propenoic acid, (2,2-dimethyl-1,3-dioxolan-4-yl)methyl ester

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 09 JUL 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

2019

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

No 440/2008

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

TEST MATERIAL
- Name of test substance: IPGA
- Chemical name: 2-Propenoic acid, (2,2-dimethyl-1,3-dioxolan-4-yl)methyl ester
- Batch number of test material: 0812-HS-0030
- Date of production: 16 Oct 2018
- Expiry Date: 28 Apr 2022
- Purity: 96.2%
- Homogeneity: Homogeneous
- Physical state/appearance: colorless, clear liquid
- Water solubility: 35.2 g/L ± 0.5 g/L at T = 20.0°C ± 0.5 °C

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Stability during storage: The stability under storage conditions over the exposure period was guaranteed by the sponsor, and the sponsor holds this responsibility.The test facility is organizationally independent from the BASF SE sponsor division.

Analytical monitoring:

yes

Details on sampling:

Sampling for concentration control analysis was performed for two renewal intervals. For the first interval samples were collected within 30 min before insertion of the test organisms (0 h) from all test vessels and after 48 hours from all test vessels with surviving fish and the lowest concentration with 100% mortality. For the second interval, samples were collected from fresh test solutions within 30 min of test solution renewal at 48 hours and after 96 hours from all test vessels with surviving fish. Samples were taken from the middle of the test vessel using a glass pipette and were transported to the analytical laboratory in 50 mL glass ampoules on the day of sampling. The sample volume was 20 mL.
All samples were analyzed immediately upon receipt in the analytical laboratory (Analytical Chemistry Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany).

Vehicle:

no

Details on test solutions:

The test treatments were prepared separately for each test vessel. The test substance was homogenized by shaking the container before use. The test substance was weighed into a beaker. The defined volume of test water was added to the test vessel and an aliquot removed, mixed with the test substance in the beaker using a high shear mixer (Ultra Turrax, IKA Werke GmbH & Co. KG, Germany) and poured back into the test vessel. The test treatment was homogenized again with an ultra turrax. Fresh test solutions were prepared at the start of the experiment and after 48 h. All test treatments were visibly clear over the entire exposure period.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: The fish were hatched at the testing facility.
- Age at study initiation: approx. 3 months
- Body length: 1.7 cm (range 1.3 cm – 2.3 cm)*
- Body weight: 0.040 g (range 0.025 g – 0.057 g)*
- Hatching date: 27 - 29 APR 2021

*Measurements are performed with a representative sample of the fish batch prior to initiation (02 Jul 2021) from 10 fish in the holding tank. Body weight is wet weight and body length is total length from the top of the snout to the end of the caudal fin.

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Type of food during acclimation: Commercial fish diet “TetraMin” (Tetra GmbH, Melle, Germany)
- Feeding frequency during acclimation: daily, additionally generally on workdays live juvenile brine shrimp (Artemia nauplii); no feeding from approx. 24 hours before start of exposure
- Health during acclimation (any mortality observed): During acclimatization, the general health status of the fish was observed for signs of sickness, injury, or other abnormalities. 0% mortality during the last week before start of exposure.

Test type:

semi-static

Water media type:

freshwater

Remarks:

Non chlorinated charcoal-filtered drinking water from the municipal water works of the city of Frankenthal mixed with deionized water, hardness approx. 100 mg/L as CaCO3, pH generally 7.5 - 8.5z.

Limit test:

no

Total exposure duration:

96 h

Hardness:

approx. 100 mg/L as CaCO3

Test temperature:

23°C

pH:

7.5-8.5

Dissolved oxygen:

>60% air saturation value

Nominal and measured concentrations:

0 (control), 2.2, 4.6, 10, 22, 46, and 100 mg/L as nominal concentrations based on test substance mass without a correction for purity or content;

0 (control), 2.0, 4.17, 8.96, 19.4, 42.3, 95.4 mg/L as mean analytically measured concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 Liter stainless steel aquaria (29 x 21 x 22 cm)
- Test volume: 10 L
- Aeration: Continuous slight aeration via glass capillary.
- Renewal rate of test solution (frequency): To help ensure constant exposure conditions throughout the test, this study was conducted as a semi-static-renewal exposure. The renewal period was 48 hours.
- No. of organisms per vessel: 7
- Biomass loading rate: mean: 0.028 g fish/L
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Non chlorinated charcoal-filtered drinking water from the municipal water works of the city of Frankenthal mixed with deionized water, hardness approx. 100 mg/L as CaCO3, pH generally 7.5 - 8.5z.
- Total organic carbon (control): 0.9 mg/L at the start of exposure
- pH: 8.4-8.5
- Dissolved oxygen: 8.1-8.4 mg/L (The concentrations of dissolved oxygen were maintained above 60% of the maximum saturation at the test temperature of 23ºC (i.e. >5.2 mg/L))
- Hardness (control): 1.32 mmol/L
- Intervals of water quality measurement: 24 h

OTHER TEST CONDITIONS
- Photoperiod: 16h light, 8h dark
- Light intensity: approx. 120-675 lux (the light intensity is determined in regular intervals at the surface of the aquaria)

TEST CONCENTRATIONS
In a preliminary test (experimental conduct in accordance with GLP, but without a GLP status) using zebrafish, the 96-hour LC50 was estimated at 10 mg/L. Thus, the following concentrations were applied: 0 (control), 2.2, 4.6, 10, 22, 46, and 100 mg/L.

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

4.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

10.29 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Since the mean measured concentrations of the test substance in the test solutions were within ±20% of the nominal concentrations, the effect concentration can be expressed relative to the nominal concentration for the evaluation of the test substance.

No mortality was observed in the test item concentrations up to and including 4.6 mg/L. 100% mortality occured in the concentrations 22, 46 and 100 mg/L.
Therefore, the 96-hour LC50 was determined to be 10.29 mg/L (based on nominal concentrations), 9.21 mg/L (based on mean measured concentrations).

Reported statistics and error estimates:

For the statistical evaluation of the data and calculation of the LC50 the probit method (Finney,
1971) was used and performed with the commercial software "TOXRAT Professional 2.10”
(ToxRat Solutions GmbH, Alsdorf, Germany).

Validity criteria fulfilled:

yes

Conclusions:

For the acute toxicity test with Danio rerio after 96 h a LC50 of 10.29 mg/L was obtained (based on the nominal concentration) for the test item.
All mean measured concentrations deviated less than 20% from the nominal concentration. Therefore, exposure conditions were consistent, and results can be expressed relative to the nominal concentrations.

Executive summary:

In a 96-hour acute toxicity study, zebrafish (Danio rerio) were exposed to IPGA at nominal concentrations of 0 (control), 2.2, 4.6, 10, 22, 46, and 100 mg/L, corresponding to mean measured concentrations of 0 (control), 2.0, 4.17, 8.96, 19.4, 42.3, 95.4 mg/L under static/renewal conditions in accordance with the OECD 203 test guideline. The water pH, temperature and dissolved oxygen were within acceptable guideline specifications.

No mortality was observed in the test item concentrations up to and including 4.6 mg/L. 100% mortality occured in the concentrations 22, 46 and 100 mg/L.
Therefore, the 96-hour LC50 was calculated as 10.29 mg/L (based on nominal concentrations), 9.21 mg/L (based on mean measured concentrations).

Description of key information

For the acute toxicity test with Danio rerio after 96 h a LC50 of 10.29 mg/L was obtained (based on the nominal concentration) for the test item.

 

All mean measured concentrations deviated less than 20% from the nominal concentration. Therefore, exposure conditions were consistent, and results can be expressed relative to the nominal concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

10.29 mg/L