Icosyl acrylate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

from 2012-01-26 to 2012-04-05

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:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Water quality parameters pH-value, temperature and oxygen-saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable Iimits.The concentration of the test item in the loading Ievel and the control were analytically verified via analysis of organic carbon (TOC, according to DIN EN 1484) at the start of the exposure.

Vehicle:

no

Details on test solutions:

- Preparation of test solutions: A single water accommodated fraction (WAF) of 100 mg/L was prepared with dilution water three days prior to the application. The test item dispersion was stirred for three days with a magnetic stirrer at room temperature. After a separation of the phases and 1 min of standing, the WAF was taken from the homogeneaus phase.
- Test loading: Per definition of the WAF, all terms related to concentration Ievels were given as loading Ievels because partly dissolved compounds anmixtures cannot be related to concentrations.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Niedersächsischer Landesbetrieb für Wasserwirtschaft, Küsten und Naturschutz, Hildesheim)
- Length at study initiation: Average body length at the start of exposure: 2.63 cm
- Weight at study initiation: Average body weight at the start of exposure: 0.284 g
- Food type: Sera Vipan; SERA GmbH, Heinsheim;
- Amount: Food was provided 3 times per week. The amount of food was 4% of the fish body weight per feeding day.
- The test fish were not fed 24 h before the start of the exposure.
- Water: Fish were held at the test facility at 23 ± 2 °C and diffuse light (0.1 - 10 µmol photons · mexp-2 *sexp-1 natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value .
- Holding: Tap water of local origin was used for holding and testing. The water was fi ltered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal water parameters: Total hardness: 10- 250 mg CaCO3/L, pH-value: 6.0 - 8.5.

ACCLIMATION
- Acclimation period: at least 12 days
- Health during acclimation (any mortality observed): mortality < 5 % within this period of time were used in the test. No disease treatments were administered throughout holding and testing.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Total hardness: 10 - 250 mg CaCO3/L

Test temperature:

20 - 24 °C +/- 1°C

pH:

pH-value: 6.0 - 8.5

Dissolved oxygen:

not less than 60 % of air saturation value

Nominal and measured concentrations:

A single water accommodated fraction (WAF) of 100 mg/L was prepared and tested.
The mean measured TOC content was 2.7 mg/L at the test solution and 1.7 mg/L at control.

Details on test conditions:

TEST SYSTEM
- Test Method: A static test was performed . A single concentration was prepared prior to the start of the exposure.
- Test duration: 96 h
- Test vessel: 3 L glass aquaria
- Type: covered with glass plates
- Material, size, headspace, fill volume: 11.5/13/20 cm, depth of water: 16.5 cm
- Aeration: gentle aeration was provided
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.795 g/L
- lntroduction of fish: The fish will be introduced randomly to individual replicates.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding and testing
- Intervals of water quality measurement: 2, 24, 48, 72 and 96 h

OTHER TEST CONDITIONS
- Photoperiod:a natural 12 - 16 h photoperiod occurred during the exposure

EFFECT PARAMETERS MEASURED: mortality and symptoms

TYPE AND FREQUENCY OF MEASUREMENT AND OBSERVATIONS
- Water quality and light intensity measurements: pH-value, temperature and oxygen saturation were measured in all test vessels at the beginning and at the end of the exposure and every 24 hours. ln the control, total hardness of the water was determined at the beginning of the exposure. During exposure, the water temperature was recorded continuously ( once per hour) by a data Iogger. The light intensity on the surface of the test aquaria were measured at the start of the test.
- Observation intervals: Observations were made after 3, 24, 48, 72 and 96 h.
- Criteria of effects: Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if tauehing of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.).
- Measurement of fish size: At the start of the exposure, body weight and total length of a representative number of 7 test fish was determined . These fish were not used for testing.
- Equipment:
Analytical balance: LA230-S, SARTORIUS
Balance: Model EW 3000-2M; FA. KERN
Oxygen, pH, temperature: HQ 40d multi, HACH LANGE
Magnetic stirrer: Variamag Mono, THERMO SCIENTIFIC
Spectrophotometer: NANOCOLOR® UV/VIS, MACHEREY-NAGEL
Data Iogger: TESTO
Filter of activated charcoal: BERKEFELD FILTER
Quantum sensor: SKP 2151091 4664 (SKYE INSTRUMENTS L TO.)
TOC analyzer multi N/C 3100 (ANALYTIC JENA)

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

In this study, the test substance was found to cause no toxic effects to Zebrafish after 96 hours when tested with a loading level of 100 mg/L.
Therefore, the NOEL was laid down as 100 mg/L. The LL50 after 96 hours was > 100 mg/L. All effect levels are given based on the nominal level of the test item.
The LL0 and LL100 after 96 h were determined directly from the test results. LL50-values have not to be calculated in a Iimit test.
- LL0: The highest tested loading Ievel of the test item with 0 % mortality.
- LL50: The loading Ievel of the test item with a mortality of 50 %.
- LL100: The lowest tested loading Ievel of the test item with 100 % mortality.
Validity criteria is fulfilled.

Results with reference substance (positive control):

No reference item is recommended for this test according to the guideline.

Sublethal observations / clinical signs:

Observations in the Test Vessels

Nominal test item loading level [mg/l]	Effect *	Test Duration [hours]
		24	48	72	96
100	(1)	7/7	7/7	7/7	7/7
Control	(1)	7/7	7/7	7/7	7/7

*) The numbers in brackets correspond to the following observation:

1) = Normal behaviour

Cumulative Mortality [%] in the Test Vessels

 

Nominal test item loading level [mg/l]	Test Duration [hours]
	24	48	72	96
100	0	0	0	0
Control	0	0	0	0

 

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-11-8 to 2012-11-16

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:

(adopted 17th July 1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): <0.02 mg/L

Analytical monitoring:

yes

Details on sampling:

Analysis of the test substance loading rate was conducted immediately after the test substance loading was freshly prepared, after 24, 48 and 72 h and at the end of the exposure.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water accommodated fraction (WAF) approach

The loading of the test material was prepared by adding the respective amount of an acetonic stock solution to an empty glass vessel. After complete evaporation of the solvent, the natural water was added, moderately stirred for 96 h, followed by filtration (MILLIPORE AP15 glass fiber filter). The resulting water soluble fraction was used in the test.

- Controls: Dilution water

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio (Zebrafish)
- Source: Reliable commercial supplier
- Age at study initiation: Young
- Length at study initiation: 1-3 cm
- Weight at study initiation: 24-128 mg
- Method of breeding: Culturing in aquaria
- Feeding during test. No
- Food type: The fish are fed commercially prepared diet Sera micropan and Sera vipan (Sera apanristic GmbH, D-52525 Heinsberg, Germany); Continuously aerated tap water of the town of Schlieren
- Amount: No data
- Frequency: Until 24 hours prior to the exposure.

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: Same as test
- Type and amount of food: The fish are fed commercially prepared diet Sera micropan and Sera vipan (Sera apanristic GmbH, D-52525 Heinsberg, Germany)
- Feeding frequency: Until 24 hours prior to the exposure.
- Health during acclimation (any mortality observed): No

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

CO3: 146-188 mg/L

Test temperature:

21-25 °C

pH:

6.0-8.5

Dissolved oxygen:

The total dissolved oxygen concentration is kept >60% of the saturation value with aeration via Pasteur pipettes

Salinity:

Cl: 7-11.5 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: <0.02 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria filled with 1.0 liter of water.
- Type: Closed
- Material, size, headspace, fill volume: Glass, 2 L (14.5 x 14.0 x 9.5 cm)
- Aeration: Yes
- No. of vessels per concentration: 1
- No. of vessels per control: 1

TEST MEDIUM / WATER PARAMETERS
- Conductivity: 454-542 µS/cm
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h photoperiod a day, supplied by overhead white fluorescent tubes, no transition period.
- Light intensity: No data

TEST CONCENTRATIONS
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: Further aquatic test studies with the loading rate of 100 mg/L.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

Loading rate

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

Loading rate

Basis for effect:

behaviour

Details on results:

- Behavioural abnormalities: No
- Observations on body length and weight: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1988-07-25 to 1988-07-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets National Standard Methods (DIN) with acceptable restrictions Read across was performed with Laurylacrylat 12/14 (mixture of laurylacrylate (CAS No.: 2156-97-0) and tetradecylacrylate (CAS No.: 21643-42-5) . Please refer to IUCLID section 13 for read across justification.

Qualifier:

according to guideline

Guideline:

other: German industrial standard test guideline DIN 38 412, part L 15, JUNE 1982

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The dose was chosen based on a range finding study.
- The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria. Based on the results of a range finding study (LC 50 after 96 h: between 100 and 1000 mg/L) the concentrations, spaced by a factor of about 2.2, were fixed as follows: 100, 215, 464 and 1000 mg/L.
- Vehicle/solvent: none
- Stability of the test chemical solutions: no data

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus Idus L., Goden variety
- Source: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation: 7.7 cm (Range: 6.9 -8.9)
- Weight at study initiation: 4.3 g (Range: 2.8 - 6.6)
- Feeding during test : 1 day before and during exposure (withdrawal of food)

ACCLIMATION
- Acclimation period: 3 days
- Acclimation conditions: same as test
- Type and amount of food: yes, ad libitium (Growing Feed F/B 50, SSniff Spezialdiaeten GmbH, D-4770 Soest, FRG)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

2.5 mmol/L

Test temperature:

20 °C

pH:

7.5 - 7.9

Dissolved oxygen:

7.3 - 8.5 mg/L

Nominal and measured concentrations:

Nominal concentration: 0, 100, 215, 464, 1000 mg/L
No concentrations were measured.

Details on test conditions:

TEST SYSTEM
- Test vessel: all-glass aquaria
- Type: open
- Material, size, headspace, fill volume: 30x 22 x 24 cm, 10 L
- Aeration: aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 4.3 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/mg ratio: 4:1
- Intervals of water quality measurement: 1, 4, 24, 48, 72, 96 hours

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light/dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

215 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 460 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

215 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Biological Observations: At the test concentration of 464 mg/L a number of fish showed apathy after 48, 72 and 96 hours. At the highest substance concentration (1000 mg/L) tumbling and narcotic-like state were observed after 24 h among the fish.
- Lowest test substance concentration causing 100% mortality: 1000 mg/L
- Mortality of controls: none

Results with reference substance (positive control):

Positive control of animals conducted with chloroacetamide: LC 50 after 48 h: about 26 mg/L
This lethal concentration corresponds to the normal sensitivity.

Reported statistics and error estimates:

Probit analysis according to Finney DJ (1971). Probit Analysis, Cambr. Univ. Press, 3rd Ed.

Description of key information

 The ecotoxicological potential to fish is assessed based on data available for 2-Propenoic acid, C12-14alkyl esters [84238-60-8], 2-Propenoic acid, C16-18-alkyl esters (CAS 90530-21-5), and 2-Propenoic acid, C18-22-alkyl esters (CAS 85085-17-2).

 

Table 1. Short-term toxicity to fish.

Ester	Method	Species	LC50/LL50 [96hrs]	Reference
2-Propenoic acid, C12-14-alkyl esters [84238-60-8]	DIN 38412, part 15	Leuciscus idus	Ca. 460 mg/L	BASF SE 1988
2-Propenoic acid, C16-18-alkyl esters [90530-21-5]	OECD 203	Danio rerio	>= 100 mg/L	BASF SE 2012
2-Propenoic acid, C18-22-alkyl esters [85085-17-2]	OECD 203	Danio rerio	> 100 mg/L	BASF SE 2012

 

Conclusion

The absence of short-term toxic potential to fish was demonstrated byin vivoassays for 2-Propenoic acid, C12-14-alkyl esters (84238-60-8), 2-Propenoic acid, C16-18-alkyl esters (90530-21-5) and 2-Propenoic acid, C18-22-alkyl esters (85085-17-2). With regard to the observed LC50 [96 h] values of > 100 mg/L (WAF) it can be concluded that all members of the category are not toxic to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

460 mg/L

Additional information

The test substance 2-Propenoic acid, C12-14-alkyl ester was tested in a 96 h acute toxicity study to golden orfe according to DIN 38412. The nominal concentrations were 0, 100, 215, 464 and 1000 mg/L. The observed symptoms were apathy, narcotic-like state, tumbling. The LC100 and the LC50 were 1000 mg/L and 460 mg/L, respectively. The NOEC-value and the LC0 were 215 mg/L and 215 mg/L (BASF 1988).

 

The acute lethal toxicity of 2-Propenoic acid, C16-18-alkyl esters (CAS 90530-21-5) to Danio rerio (Zebrafish) was investigated under static exposure conditions over a period of 96 h, using the Water Accomodated Fraction (WAF) approach. The singly applied loading rate was 100 mg/L. GC-FID analysis of the test substance was conducted in the definitive test at the beginning of the test and after 24, 48, 72 and 96 h of incubation. The test concentration was below the quantification limit of 0.02 mg/L throughout the test. Thus, evaluation was based on the loading rate. At the loading rate of 100 mg/L, none of a total of seven fish died after 96 h of exposure. No mortality was observed in the blank control. Toxic effects other than mortality, e.g. loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed. The no-observed-effect concentration (NOEC) was 100 mg/L with respect to the loading rate. 100% mortality (LC100) could not be detected. Based on the binominal theory, the absence of mortality provides at least 99% confidence that the LC50 is greater than the applied loading rate of 100 mg/L (BASF SE, 2012).

 

The acute toxicity to fish (zebrafish), of the test substance and 2-Propenoic acid, C18-22-alkyl esters was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) and EU Council Regulation No. 440/2008/ C.1 (2008). A static test was performed. A single water accommodated fraction (WAF) of 100 mg/L was prepared and tested. Per definition of the WAF, all terms related to concentration Ievels were given as loading Ievels because partly dissolved compounds and mixtures cannot be related to concentrations. The duration of the test was 96 hours. Seven test organisms each were exposed to the WAF and the control. Water quality parameters like pH-value, temperature and oxygen-saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable Iimits. The concentration of the test item in the loading Ievel and the control were analytically verified via analysis of organic carbon (TOC, according to DIN EN 1484) at the start of the exposure. All effect Ievels are given based on the nominal loading of the test item. The NOEL was laid down as 100 mg/L. The LL50 after 96 hours was > 100 mg/L. All effect levels are given based on the nominal level of the test item. Therefore the test substance was found to cause no toxic effects to zebrafish after 96 hours when tested with a loading level of 100 mg/L (BASF SE, 2012).