Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

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:

September 23, 2019-September 27, 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M FMRD, CPDC lot 6
- Expiration date: 2021.09.27
- Purity: 99.1%
- Physical state: Clear colorless liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stored at room temperature: In the sample chamber of this facility, stored at room temperature (15-25°C).
- Stability under test conditions: Unstable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (negative control), 100 mg/L (limit test)
- Sampling method: A sample of ~50 mL was taken from each test solution and control solution. The sample was taken from the leftover test solution for fresh samples and from the aquarium for old samples. 10 mL of the sample was pre-treated before analysis. The remaining sample was stored in refrigerator for possible re-analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of the test solutions started with the highest concentration of 100 mg/L, applying a 24 hour period of magnetic stirring (350 to 360 rpm) to attempt dissolution of the test item in medium. The test item was allowed to separate to the surface of solution for about 30 minutes, and the test solution on the bottom was taken to use for exposure.
- Controls: Test medium without test substance or other additives.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Hangzhou Hunter Biotechnology Inc.
- Length at study initiation: 1.8-2.0 cm
- Weight at study initiation: 0.0521-0.0762 g


ACCLIMATION
- Acclimation period: 2 months
- Acclimation conditions: Fish were held in water of the quality to be used in the test
- Feeding frequency during acclimation: Twice on weekday and one time on weekend until 24 hours before the test was started.
- Health during acclimation: No signs of disease or mortalities


FEEDING DURING TEST : No feeding during test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

190 mg/L (CaCO3)

Test temperature:

20.7 - 22.8 °C

pH:

7.73-8.25

Dissolved oxygen:

81.5%-99.5% (ASV)

Nominal and measured concentrations:

Nominal concentrations: 0 mg/L, 100 mg/L (nominal)
Measured: Controls,

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass tanks
- Material, size, headspace, fill volume: 5L fill volume (length: 30 cm, width: 20 cm, height: 30 cm), 18 Liters tanks
- Aeration: Yes. Before usage, the dilution water was aerated for more than 24 hours to attain dissolved oxygen saturation. No aeration during the test.
- Renewal rate of test solution: Every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 0.34 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water treated with Aquapro Pure Water System
- Total organic carbon:<2 mg/L
- Particulate matter: All less than detection limits
- Metals:All less than detection limits
- Pesticides: All less than detection limits
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 12 hours light: 12 hours darkness, cool white light
- Light intensity: 540-1000 Lux

EFFECT PARAMETERS MEASURED: Observations for mortality and other sub-lethal effects such as stress were measured by observation at 3.75, 24, 48, 72 and 96 hours during the test.

TEST CONCENTRATIONS
- Range finding study : Yes
- Test concentrations: 0 mg/L (control) and 100 mg/L (nominal loading rate)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No mortality observed

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.065 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control:No
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: Yes

Results with reference substance (positive control):

24 hour LC50=257.1 mg/L

Sublethal observations / clinical signs:

Table 1. Concentrations of Test Item in the Exposure Solution

Nominal concentration (mg/L)	Time	Measured concentration (Component 1 -22.8%)	Measured concentration (Component 2 -68.1%)	Measured concentration (Total -90.9%)	Dilution Factor	Sample Concentration (mg/L)	Geometric Mean of Fresh (mg/L)	Geometric Mean of Old (mg/L)	Geometric mean of overall (mg/L)
Control	0d-Fresh	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	1d-Old	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	3d-Fresh	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	4d-Old	<LOD	<LOD	<LOD	1	<LOD	/	/	/
100	0d-Fresh	0.0062	0.0166	0.0228	50	1.1400	1.05	0.0040	0.065
	1d-Old	0.0011	0.0054	0.0065	1	0.0065#	1.05	0.0040	0.065
	3d-Fresh	0.0043	0.0150	0.0193	50	0.9650	1.05	0.0040	0.065
	4d-Old	<LOD	<LOD	0.0025	1	0.0025*	1.05	0.0040	0.065

Note: LOD is 0.005 mg/L, LOQ is 0.01 mg/L, "/" means not calculated.

"*" 1/2 LOD is used for calculation of the geometric means.

"#" Value below LOQ.

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%), DO >60% ASV (81.5%-99.5%)

Conclusions:

96 hour LC50 >100 mg/L (nominal) in Danio rerio (OECD 203)
96 hour LC50 >0.065 mg/L (measured) in Danio rerio (OECD 203)

Executive summary:

The 96 hour LC50 of MTDID 44430 to Danio rerio was determined in a limit test according to OECD 203 guidelines. Nominal concentrations of 100 mg/L and a blank control were run using 7 animals per tank, with one replicate per concentration, and no dispersant. No mortality or behavioral abnormalities were observed throughout the test. An LC50 >100 mg/L (nominal concentration) was determined.

Study was conducted under international guidelines and was compliant with GLP criteria. Test substance concentrations were not maintained at >=80% of the initial throughout the test and were below LOD after 24 hours (at renewal) at one of two measured timepoints. However, the test was conducted with a semi static method and is therefore considered reliable with restrictions. The result is considered suitable for use in Risk Assessment, Classification & Labeling,  and PBT analysis.

Description of key information

96 hour LC50 >100 mg/L (nominal) in Danio rerio (OECD 203)

96 hour LC50 >0.065 mg/L (measured) in Danio rerio (OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The 96 hour LC50 of MTDID 44430 to Danio rerio was determined in a limit test according to OECD 203 guidelines. Nominal concentrations of 100 mg/L and a blank control were run using 7 animals per tank, with one replicate per concentration, and no dispersant. No mortality or behavioral abnormalities were observed throughout the test. An LC50 >100 mg/L (nominal concentration) was determined.

Study was conducted under international guidelines and was compliant with GLP criteria. Test substance concentrations were not maintained at >=80% of the nominal throughout the test and were below LOD after 24 hours (at renewal) at one of two measured timepoints. However, the test was conducted with a semi static method and is therefore considered reliable with restrictions. The result is considered suitable for use in Risk Assessment, Classification & Labeling,  and PBT analysis.