Fatty acids, C8-10-(even numberd), Esters with pentaerythritol and adipic acid

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:

13 Jan - 15 Feb 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP Guideline study with acceptable restrictions: While using the "oil-in-water dispersion"-method instead of the "water-accomodated fraction"-method undissolved test material was not removed from the test vessels. However, as no toxic effects were recorded at any test concentration this test is still considered to be valid.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

the "oil-in-water dispersion"-method was used instead of the "water-accomodated fraction"-method although the test substance is poorly soluble in water

Qualifier:

according to guideline

Guideline:

other: SEPA (HJ/T 153-2004)

GLP compliance:

yes

Remarks:

State Environmental Protection Administration (SEPA) of the Peoples's Republic of China

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Samples were taken from each concentration on five occasions during the limit test (0, 24, 48, 72 and 96 h). On each occasion, one sample was analysed after filtrated through a 0.45 µm millipore filter. The remaining samples were retained in case further analysis would be required.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was dispersed directly as a neat liquid in the test water using the oil-in-water dispersion (OWD). The test substance was measured out using glass syringes. Syringes were weighed before and after adding the test material to determine the actual loading rate and to give the nominal concentrations. The dispersion motors were allowed to run in the test chamber prior to introducing the test substance. The oil-in-water dispersion solutions were mixed continuously for 96 h without renewal. The stainless steel mesh and stainless steel cylinder (see picture) allow for the OWD solution to be well mixed, dispersed and to flow throughout the mixing column and the aquarium tank.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: obtained as fry from a commercial fish supplier of Guangzhou Hongfa Aquatic Animals Culture Company in China:
- Length at study initiation: 2-3 cm
- Weight at study initiation: 0.3 g
- Method of breeding: Feeding fry were held for a minimum of 12 days in holding tanks supplied with a continuous flow of aerated water before being used for testing.
- Feeding during test: no

ACCLIMATION
- Acclimation period: Fish to be used in the test were held foer at least 7 days in water of the quality and temperature to be used in the test.
- Acclimation conditions: same as test
- Type and amount of food: proprietary fish food; fish were held without food ~ 24 h before being placed into the test vessels
- Feeding frequency: daily
- Health during acclimation: Following a 48 h settling-in period, mortalities were recorded and no dead fish was found during the holding period.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

139 - 142 mg/L as CaCO3

Test temperature:

23.3 - 23.5 °C

pH:

7.61 - 8.01

Dissolved oxygen:

> 100% saturation

Nominal and measured concentrations:

Nominal: 100 and 150 mg/L
Measured (arith. mean): 0.696 and 0.704 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Size: 8 L; Fill volume: 5 L
- Aeration: yes
- 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: dechlorinated tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: Measurements of pH, dissolved oxygen and temperature were carried out and recorded daily.

OTHER TEST CONDITIONS
- Photoperiod: 12 h light/ 12 h dark

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Range finding study: Groups of fish (5 per group) were exposed 96 h to three widely-spaced concentrations of the test substance. One control group was tested. For each test tank (8 L) 5 L test solution was filled in. No replicates were tested.
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality occured at the tested concentrations.

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.704 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortality was observed in the control and the test concentrations.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50 (24 h): 266 mg/L (229 -309 mg/L) at a nominal test concentration of 500 mg/L

Sublethal observations / clinical signs:

Table 1: Stability test results of the test substance in test medium

Exposure time [h]	Concentrations [mg/L]
	Nominal	Measured
0	100	0.684
	150	0.701
24	100	0.712
	150	0.723
48	100	0.687
	150	0.694
72	100	0.691
	150	0.695
96	100	0.704
	150	0.708

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

11 - 15 Feb 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP guideline study: The test substance was not analytically monitored and no purity of the test substance is given.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

no

Remarks:

But conducted in accordance with ISO/IEC 17025

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution is prepared in accordance with the OECD monography n° 23. Aqueous solution is saturated with the substance to be tested by dynamic contact setting with a known amount of the test substance. The preparation was gently agitated for 68 hours by magnetic stirring (30 rpm to 60 rpm), followed by a 4 hour phase of separation. The aqueous phase, containing the soluble substance (Water Accomodated Fraction) is used in the test.
The test solution is identified according to its loading ratio (mass fraction of substance to be tested/ test medium mass introduced into the diphasic reactor) while operating the WAF.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Bassler Biofish, stationstraat 130, 2235 Westmerbeek, Belgium
- Length at study initiation: 25 - 30 mm
- Feeding during test: no

ACCLIMATION
- Acclimation period: The fish have been acclimatized for at least 7 days.
- Acclimation conditions: same as test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

200 - 250 mg/L as CaCO3

Test temperature:

23 ± 1 °C

pH:

7.8 ± 0.2

Dissolved oxygen:

8.4 - 8.5 mg/L (≥ 90% saturation)

Nominal and measured concentrations:

Nominal: 1000 mg/L loading rate WAF

Details on test conditions:

TEST SYSTEM
- Test vessel: fish tank
- Aeration: yes,gently blowing bubbles using ambient air
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 0.9 - 1.0 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water (= test medium) is prepared according to OECD guideline 203
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature was regulated permanently by placing the tanks in thermostatic enclosures. The pH and the dissolved oxygen level were measured daily in the blank and the test solutions.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h photoperiod

EFFECT PARAMETERS MEASURED: Mortality was recorded after 24, 48, 72 and 96h exposure to the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test
- Justification for using less concentrations than requested by guideline: The highest concentration of the test substance soluble in water was tested.
- Range finding study: This study represents a limit test. Therefore, no range finding study was performed.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: No mortality occurred in the control and the treatment during the 96h exposure period.

Results with reference substance (positive control):

The LC50(24h) obtained with potassium dichromate from the stock population of acclimatized fish was measured to be 235 mg/L. The relative difference between this value and the average of the previous results obtained by our laboratory does not exceed 20%.

Reference 3

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:

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

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: RA-A, CAS 95912-89-3, Nyco, 2008, D. rerio, RL2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: RA-A, CAS 71010-76.9, Exxon, 2009, B. rerio, RL2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.704 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: RA-A, CAS 71010-76.9, Exxon, 2009, B. rerio, RL2

Conclusions:

The key values for the short-term toxicity of the target substance is an LC50 (96 h) > 0.704 mg/L (nominal, WAF) based on the experimental studies for two structrually and chemically closely related source substances (OECD 203, D. rerio and B. rerio).

Additional information

There is no study available, in which the short-term toxicity of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) to fish was assessed. Therefore, read-across to the structurally and chemically closely related source substance Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) and Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by similar chemical structure and is therefore considered a suitable representative for the assessment of the short-term toxicity of the target substance to fish. A detailed read-across justification in provided in IUCLID section 13.

All available studies with the target and the source substance were conducted according to internationally accepted guidelines and GLP. The source substances Fatty acids, C8-10, mixed esters with adipic acid and trimethylol-propane (CAS 95912-89-3) and Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) did not indicate any toxicity up to the water solubility limit for the available acute and long-term tests with freshwater fish, aquatic invertebrates and aquatic algae.

Two studies on the short-term toxicity to fish were conducted according to OECD guideline 203 investigating the toxicity of the source substance Fatty acids, C8-10, mixed esters with adipic acid and trimethylol-propane (CAS 95912-89-3) and decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9).

One study investigating the short-term toxicity of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) to freshwater fish is available. The study was conducted under semi-static conditions according to OECD guideline 203 using Danio rerio as test organism. A 1000 mg/L loading rate Water Accommodated Fraction (WAF) was used in a limit test. No mortality occurred in the control and the treatment during the 96 h exposure period. Hence, the LL50 (96 h) is determined to be > 1000 mg/L loading rate based on the nominal concentration. Based on this result it can be concluded that no toxicological short-term effects on fish are expected up to the limit of water solubility for Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3).

One study investigating the short-term toxicity of the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) to freshwater fish is available. The study was conducted under static conditions using Brachydanio rerio as as a test organism. Nominal test concentrations of 100 and 150 mg/L were applied. Test substance monitoring using TOC analysis measured test concentrations of 0.696 and 0.704 mg/L, respectively. Undissolved test material was not removed from the test system; however, this is considered negligible, because no mortality was observed in any treatment and the control throughout the test period of 96 h. Hence, the 96 h-LC50 is determined to be > 0.704 mg/L (arithmetic mean). Based on the available results from structurally related read-across substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that the target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) is not actuely toxic to fish.