monoesters of C16 and C18 (branched and linear) fatty acids with decan-1-ol

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)

Adequacy of study:

key study

Justification for type of information:

Refer to the analogue approach justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Conclusions:

The effect value for the short-term toxicity to fish is an LL50 (96 h) > 100 mg/L (nominal) based on experimental data from reliable read-across source substances (OECD 203).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 - 18 May 2002

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:

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.

Description of key information

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

Additional information

No study is available, in which the short-term toxicity of the target substance Monoesters of C16 and C18 (branched and linear) fatty acids with decan-1-olto fish was assessed. Therefore, read-across to the structurally related source substancesdodecyl oleate (CAS 36078-10-1)and2-ethylhexyl oleate (CAS 26399-02-0) was conducted in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5. The source substances are characterized by similar fatty acid and alcohol components as the target substance and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to fish. A detailed read-across justification is provided in the analogue justification in IUCLID section 13.

The available study with the source substance dodecyl oleate (CAS 36078-10-1) was conducted according to OECD 203 and GLP (key study). In a static limit test, the model organism Danio rerio was exposed to a Water Accommodated Fraction with a nominal loading rate of 100 mg/L for 96 h. The actual test item concentration in the test medium was analytically verified by GC-MS at the beginning and end of the test.

The chemical analysis of the actual test item concentration in the test medium resulted in concentrations below the limit of detection (0.005 mg/L), reflecting the very low water solubility of the test item. After 96 h, no mortality was observed, resulting in an LL50 (96 h) of > 100 mg/L (nominal).

In the available study with the source substance 2-ethylhexyl oleate (CAS 26399-02-0) a semi-static test in saltwater was conducted according to OECD 203 (supporting study), in which the model organism Scophthalmus maximus was exposed to nominal test item concentrations of 0, 320, 560, 1000 and 1800 mg/L for 96 h. No analytical monitoring of test item concentrations was performed.

After 96 h, no mortality occurred, resulting in an LC50 (96 h) of > 1800 mg/L (nominal).

Based on the structural and chemical similarities between the target and source substances, the target substance is expected to exhibit a similar ecotoxicological profile as the source substances. Therefore, it is concluded that Monoesters of C16 and C18 (branched and linear) fatty acids with decan-1-oldoes not cause short-term toxic effects toward fish up to the limit of solubility.