Fatty acids, C16-18, isononyl esters

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance.

Adequacy of study:

key study

Justification for type of information:

Refer to read across justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: CAS 85049-37-2, BASF, 2001, D. rerio, 96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

other:

Remarks:

siphoned test solution

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: CAS 26399-02-0, Oleon, 2002, S. maximus, 96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: CAS 3687-46-5, BASF, 1994, D. rerio, 96 h

Conclusions:

No toxic effects to freshwater and marine fish were recorded up to the limit of water solubility (OECD 203/EU method C. 1, D. rerio/S. maximus, RA CAS 85049-37-2, 26399-02-0, 3687-46-5).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 - 18 May 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

The guideline was modifed to marine conditions.

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method
- Main test: For each concentration the required amount of homogenised samples was added to 12 L dilution water and mixed for 20 - 24 h and then allowed to separate for 4 h. Then, the sub-natant liquid was drawn off and used for the test.
- Pre-test: a 1000 mg/L solution was prepared in dilution water, shaken vigorously and allowed to stand for 1 h. A clear solution with floating material was observed.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: brill
- Source: France Turbot, Boite Postale 305, 58330 Noirmoutiers, France
- Mean length: 41.9 mm
- Mean weight: 1.98 g

ACCLIMATION
- Acclimation period: 24 Apr - 14 May 2002
- Acclimation conditions (same as test or not): Temperature: 14.0 - 14.5 °C, Disoolved oxygen: > 92% athmospheric saturation value

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

14.0 - 15.5 °C

pH:

7.7 - 8.6

Dissolved oxygen:

96 - 100% athmospheric saturation value

Salinity:

30 - 36 g/L sodium chloride

Nominal and measured concentrations:

nominal: 0, 320, 560, 1000 and 1800 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel
- Material, fill volume: aquaria filled with 10 L test solution
- Renewal rate of test solution (frequency): The test medium was renewed after 48 h.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Standardised artificial seawater using Tropic Marin formulated by Tropical Marine Centre Limited.

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality at test start and after 24, 48, 72 and 96 h.

TEST CONCENTRATIONS
- Range finding study
- Results used to determine the conditions for the definitive study: In a preliminary study the LC50 (96h) was identified to be > 1000 mg/L. Thus, the test concentrations were stated to be 320, 560, 1000 and 1800 mg/L. In addition, due to floating material in the pre-test the sub-natant liquid was drawn of in the definite test.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

other: siphoned test solution

Basis for effect:

mortality (fish)

Details on results:

No mortality occured at any test concentration and in the control at any observation time during the study period.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Apr 1994 - 15 Apr 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

Temperature deviated more than +/- 1 °C and the O2-saturation was slightly lower (54-56%) at the end of the 24 h incubation period (in four of six cases).

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1000, 10000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was added directly to the test vessels (drinking water) and stirred for 10 seconds with an ultraturrax.
- Eluate: no
- Differential loading: yes
- Controls: yes, water control
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test substance floated on top of the surface in the test vessels and the water was slightly turbid in all test concentrations.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Fa. Westaquarium (obtained on 15 Dec 1993)
- Food type: Altromin N 1324 spezial 140694 0825

ACCLIMATION
- Health during acclimation (any mortality observed): mortality < 0.1% prior to study initiation

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

20.5 - 23.5 °C

pH:

7.6 - 8.3

Dissolved oxygen:

52 - 97%

Nominal and measured concentrations:

Nominal concentrations: control - 1000 - 3000 - 10000 mg/L

Details on test conditions:

TEST SYSTEM
- Fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water

EFFECT PARAMETERS MEASURED: mortality after 0, 4-6, 24, 48, 72, 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: < 3.3

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No behavioural abnormalities were reported
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: The nominal test concentrations exceeded the water solubility of the test substance. The test substance floated on top of the water in the test vessels and the water was turbid.

Sublethal observations / clinical signs:

A mortality of 70% was observed after 72 and 96 h in the highest test concentration of 10000 mg/L. It is reported that the test substance floated on top of the water in the test vessels and the O2-saturation after 24 h was lower then the O2 -saturation limit stated in the guideline. This might also be a reason for the observed effects at the highest test concentration.

It is reported that the chemical analysis of TOC and DOC is not the appropriate method for highly insoluble substances in water.

Table 1: Mortality [%]

Concentration [mg/L]	Duration [h]
	0	4-6	24	48	72	96
0	0	0	0	0	0	0
1000	0	0	0	0	0	0
3000	0	0	0	0	0	0
10000	0	0	0	0	70	70

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 19 Jan 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study with acceptable restrictions: No analytical monitoring of the test substance is performed. No information about undissolved test material and its removal is given. However, this is considered to be negligible, because no mortality is observed in any treatment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The substance was directly weighed into the test vessels and was treated 10 seconds with ultraturrax.

ACCLIMATION
- Health during acclimation (any mortality observed): <0.1%

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

approx. 250 mg CaCO3/L

Test temperature:

22.5 - 23.5°C

pH:

7.8 - 8.3

Dissolved oxygen:

43 - 98% (air saturation)

Nominal and measured concentrations:

Nominal: 0, 1000, 3000 and 10000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: fish basin
- Size: 10 L; Fill volume: 5 L
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: standard dilution water

OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark

EFFECT PARAMETERS MEASURED : Mortality was recorded after 6, 24, 48, 72 and 96 h test duration.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortality and abnormalities were observed in the control and any treatment.

Sublethal observations / clinical signs:

Table 1: Mortality of fish in %:

Nominal Concentration [mg/L]	Incubation time [h]
	0	6	24	48	72	96
0	0	0	0	0	0	0
1000	0	0	0	0	0	0
3000	0	0	0	0	0	0
10000	0	0	0	0	0	0

Description of key information

No effects up to the limit of water solubility (OECD 203, D. rerio/S. maximus); read-across

Additional information

There is no study available assessing the short-term toxicity of the target substance Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) to fish. Therefore, read-across to the three structurally related source substances Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS 85049-37-2), 2-ethylhexyl oleate (CAS 26399-02-0) and 9-Octadecenoic acid (9Z)-, decyl ester (CAS 3687-46-5) was conducted in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5. The source substances are considered suitable representatives for the assessment of the acute toxicity of the target substance to fish. A detailed read-across justification is provided in IUCLID section 13.

The study with the source substance Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS 85049-37-2) was performed according to OECD 203. In a semi-static test, D. rerio was exposed to the nominal concentrations of 1000, 3000 and 10000 mg/L for 96 h. The test item was mixed into the dilution water by ultraturrax without further preparation. No effects were observed up to the highest test concentration and the derived LC50 (96h) was > 10000 mg/L.

The study with the source substance 2-ethylhexyl oleate (CAS 26399-02-0) was according to OECD 203 and GLP with a marine test organism. In a semi-static test, S. maximus was exposed to the nominal concentrations of 320, 560, 1000, and 1800 mg/L for 96 h. For each concentration the required amount of homogenized samples was added to 12 L dilution water and mixed for 20 – 24 h and then allowed to separate for 4 h. Then, the supernatant liquid was drawn off and used for the test. No mortality occurred during the test, and the LC50 was > 1800 mg/L (nominal).

The study with the source substance decyl oleate (CAS 3687-46-5) was conducted according to EU Method C.1 and GLP. In a semi-static test, D. rerio was exposed to 1000, 3000, and 10000 mg/L test item (nominal) for 96 h. A mortality of 70% was recorded after 72 and 96 h at the highest concentration of 10000 mg/L. However, it was reported that the substance floated on the water surface and the O2 concentration after 24 h was lower than the validity criterion stated in the guideline. Hence, the highest treatment concentration was not taken into account and the derived LC50 (96 h) was > 3000 mg/L (nominal), which is still far above the limit of water solubility (< 1 mg/L).

Based on the structural and chemical similarity of the target and source substances, the target substance is expected to exhibit a similar ecotoxicological profile. Therefore, it can be concluded that Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) will not exhibit short-term effects to fish up to the limit of water solubility.