Fatty acids, C18-unsaturated, 1,6 Hexanediol Diester

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:

key study

Study period:

23 - 27 Sept 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Only four concentrations are tested. The test concentrations are not analytically verified. A saltwater fish is tested.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Only four test concentrations were applied. The test concentrations were not analytically verified. A salt water fish was tested.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test material was added directly to the exposure chambers within one hour after addition of the test animals. The required quantity for each test concentration was pipetted into the respective exposure chambers. Nominal test concentrations were calculated using the specific gravity (0.909 g/mL) of the test material. Due to its insolubility, test substance was used as oil-water suspension (OWS). A stable OWS was generated using a modification of the procedure originating from the Ministry of Agriculture, Fisheries, and Food (MAFF), England (Blackman et al. New Procedures for the Toxicity Testing of Oil Slick Dispersants. Fisheries Research Technical Report Nr. 29, 1980, 7 p). In general, exposure chambers were fitted with a removable PVC cylinder that housed a stainless steel shaft and 3 bladed propeller. Small quantities of water and oil were drawn through the cylinder and expelled through apertures near the bottom of the the cylinder by rotating the propeller with ca. 1500 revs/min.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test solutions were turbid due to the formation of the oil-water suspension.

Test organisms (species):

Cyprinodon variegatus

Details on test organisms:

TEST ORGANISM
- Common name: sheepshead minnow
- Source: obtained from ARO Inc, Hampton, USA
- Length at study initiation: 0.17 - 0.23 cm (SD: 2 - 4 mm)
- Weight at study initiation: 0.31 - 0.39 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: The test organisms were acclimated for a minimum of 7 days prior to the test start.
- Acclimation conditions: same as test
- Type and amount of food: The fish were fed a commercial fish food (TetraMin flake food). The fishes were not fed in the 24 h preceeding study inition.
- Feeding frequency: ad libitum
- Health during acclimation: < 10% in the 48 h prior to test start

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

262 mg/L as CaCO3

Test temperature:

21.0 - 21.5 °C

pH:

8.14 - 8.21 (mean)

Dissolved oxygen:

7.74 - 8.46 mg/L

Salinity:

20 ppt

Nominal and measured concentrations:

Nominal: 500, 1000, 2500 and 5000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquaria
- Type: open
- Material: glass; Size: 10 gallon (37.9 L); Fill volume: 30 L
- No. of organisms per treatment group: 20 (control: accidentally 21 fish)
- No. of vessels per concentration: 1
- No. of vessels per control: 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: MTC well water was adjusted to a salinity of 20 ± 1 ppt with synthetic sea salts (Rila Marine Mix)
- Alkalinity: 150 mg/L as CaCO3
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature, pH, salinity and dissolved oxygen were measured in all test chambers at each 24 h observation period. Dissolved oxygen measurements were corrected for salinity since the temperature-salinity relationship is different in saltwater than in freshwater.

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

EFFECT PARAMETERS MEASURED: Mortality, abnormal behavior and appearance of fish were recorded at 0, 24, 48, 72 and 96 h test duration.

TEST CONCENTRATIONS
- Range finding study: 10 Fish per dose level were exposed for 48 h to direct additions of the test substance under OWD conditions in 10 gallon aquaria containing 30 L of water.
- Test concentrations: 10, 100 and 1000 ppm
- Results used to determine the conditions for the definitive study: The oil-water dispersion (OWD) approach was chosen as the most effective study design for the definitive study. At 1000 ppm one of 10 fishes died.

Reference substance (positive control):

yes

Remarks:

diesel oil (300 mg/L)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: 3 out of 20

Sublethal observations / clinical signs:

Comparison between the test substance and diesel oil is not meaningful since only three dead fish were observed in the positive control.

Table 1: Cumulative mortility in the different treatments [%]

Exposure time [h]	Treatment [ppm]
	Positive control	control	500	1000	2500	5000
0	0/21	0/20	0/20	0/20	0/20	2/20
24	0/21	1/20	0/20	0/20	0/20	3/20
48	0/21	3/20	0/20	0/20	0/20	4/20
72	0/21	3/20	0/20	0/20	1/20	4/20
96	0/21	3/20	0/20	0/20	1/20	4/20

Reference 2

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:

Please refer to the analogue justification attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 16958-92-2, Exxon, 1986, C. variegatus 96 h

Description of key information

LC50 (96 h) was > 5000 mg/L for fish (OECD 203); read across

Additional information

Experimental studies investigating chronic toxic effects of the target substance Fatty acids, C18-unsaturated, 1,6 Hexanediol Diester (EC 947-912-3) on fish are not available. Thus, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance Bis(tridecyl) adipate (CAS 16958-92-2) was conducted to fulfill the data requirements according to Annex VIII. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. This read-across is justified in detail within the analogue justification in IUCLID Section 13.

The acute toxicity of the source substance Bis(tridecyl) adipate (CAS 16958-92-2) to fish was investigated according to OECD guideline 203 using the salt water species Cyprinodon variegatus as test organism. Nominal test substance concentrations of 500, 1000, 2500 and 5000 mg/L were tested. The test material was directly added to the test vessels. Undissolved test material was not removed indicating a worst case. The determined LC50 (96 h) was > 5000 mg/L.

Based on the available data for the read across substance no acute toxic effects on fish are expected within the limits of water solubility of the target substanceFatty acids, C18-unsaturated, 1,6 Hexanediol Diester (EC 947-912-3).