Fatty acids, C5-9, hexaesters with dipentaerythritol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

22 Mar - 26 Mar 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (no purity of test substance).

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom (date of inspection 23 Mar 1998)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance is poorly water soluble. Previous experience from studies on such test materials has shown that a mixing period of 24 to 48 hours is sufficient to ensure equilibration between the test material and water phase. Prior to addition of the test material, dechlorinated tap water was stirred by magnetic stirrer using a stirring rate such that a vortex depth of approx. 25% of the overall height of the water column was achieved. The test material was added directly to the vortex of 20 L tap water and stirred for 23 h to give a 100 mg/L loading rate. The stirring was stopped after 23 h and the mixture was allowed to stand for 1 h. The water accommodated fraction (WAF) was then removed by filtration through 0.45 µm filters to give a 100 mg/L loading rate WAF. The test organisms were exposed to this aqueous phase or WAF which may contain dissolved test material and/or leachates from the test material. Exposures are expressed in terms of the original concentration of the test substance in water at the start of the mixing period irrespective of the actual concentration of test material in the WAF.
- Controls: yes, test water control

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Cheltenham, Gloucester, UK. Fish were maintained in-house since 23 Feb 1999.
- Age at study initiation: juvenile
- Length at study initiation: 4.1 ± 0.1 cm
- Weight at study initiation (mean and SD): 0.82 ± 0.07 g

ACCLIMATION
- Acclimation period: 10 Mar 1999 - 22 Mar 1999
- Acclimation conditions: same as test
- Type and amount of food: trout pellets
- Health during acclimation: No mortality in the 7 days prior to test start was observed.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L as CaCO3

Test temperature:

14 °C

pH:

7.6 in fresh media
7.9 in old media

Dissolved oxygen:

9.3 - 9.8 mg O2/L

Nominal and measured concentrations:

Nominal: control, 100 mg/L
Measured: < 0.00613 mg/L (limit of quantification for the control and the 100 mg/L treatment)

Details on test conditions:

TEST SYSTEM
- Test vessel: exposure vessels
- Type: covered
- Material, Size: glass; Size: 20 L
- Aeration: via narrow bore glass tubes
- Renewal rate of test solution: daily renewal of the test solution
- No. of organisms per vessel: 10
- No. of vessels per concentration: 2
- Biomass loading rate: 0.41 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated and partly softened tap water
- Total organic carbon: 1 mg/L
- Metals : Hg < 0.1 µg/L; Cd, Ag < 0.5 µg/L; Se, Sb, As < 1 µg/L; Ni, Cr, Mn < 5 µg/L; Al < 20 µg/L; Fe < 36 µg/L; B, Zn 40 µg/L, Ba 70 µg/L; Cu 10 µg/L; Pb 4 µg/L; Na 28 µg/L; K 2.1 µg/L
- Pesticides: < 0.02 µg/L
- Chlorine: 0.12 mg/L
- Ca/Mg ratio: 6.7:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature, pH and oxygen were recorded daily. The concentration and the stability of the test material in the test solutions were verified by chemical analysis after 0, 24 and 48 h.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark with 20 min dawn and dusk transition periods

EFFECT PARAMETERS MEASURED: Mortalities and sublethal effects were monitored after 3, 6, 24, 48, 72 and 96 h test duration.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 and 100 mg/L nominal concentrations
- Results used to determine the conditions for the definitive study: No mortalities or sublethal effects were observed.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No sublethal effects were observed.
- Other biological observations: No sublethal effects were observed.
- Mortality of control: 0%
- Other adverse effects control: No sublethal effects were observed.
- Abnormal responses: No sublethal effects were observed.
- Effect concentrations exceeding solubility of substance in test medium: The effect concentration exceeds the water solubility of the test substance.

Sublethal observations / clinical signs:

The test exhibited a LL50 of > 100 mg/L (nominal) based on mortality. No effects were observed in the range of water solubility. Chemical analysis of the 100 mg/L loading rate WAFs at 0, 24 and 96 h showed the measured test concentrations to be less than the limit of quantification of the analytical method which was assessed to be 0.00613 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

04 - 08 Jan 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study comparable to OECD study with acceptable restrictions: Analytical purity of the test substance is not specified. No monitoring of the test substance is performed.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

96 h acute toxicity test with rainbow trout

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An appropriate amount of the test item was weighed out into a glass vial and adding this into 20 L of dilution water. The test solutions were then stirred thoroughly.
- Eluate: no
- Differential loading: yes
- Controls: yes / water control: dechlorinated tap water
- Evidence of undissolved material: yes, the test material was not fully in solution.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Upwey Trout Farm, Upwey, Dorset, UK (obtained: 27 Oct 1992)
- Length at study termination: 42 - 58 mm (mean: 50 mm)
- Weight at study termination: 0.86 - 2.47 g (mean: 1.71 g)
- Feeding during test: none

ACCLIMATION
- Acclimation period: starting 27 Oct 1992; 1 week prior to testing the fish used for this study were held individually at 15 ± 1 °C
- Acclimation conditions: same as test conditions
- Type and amount of food: Promin medium (batch ref FF179/2). Fish were not fed for 24 h prior to the start of the study.
- Health during acclimation (any mortality observed): last mortality occured on 22 Dec 1992 (12 days prior to the test)
- Other: Last medication was given 11 days prior to the test initiation ( 1 mg/L of malachite green)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

24.0 - 24.3 mg/L as CaCO3

Test temperature:

15.0 - 15.5 °C

pH:

7.15 - 7.36

Dissolved oxygen:

9.0 - 9.8 mg O2/L

Nominal and measured concentrations:

Nominal: 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: rectangular vessels
- Material: glass; Size: 400 x 280 x 280 mm (length x width x height) with a volume of 28 L ; Headspace: 8 L; Fill volume: 20 L
- Aeration: yes
- Renewal rate of test solution: once daily
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 0.86 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water supplied from a 100 m³ reservoir with an average retention time of 24 h. It was passed through activated carbon, filtered to remove particulate material and dechlorinated with sodium thiosulphate.
- Hardness: 24.0 - 24.3 mg/L as CaCO3
- Chlorine: < 4 µg/L Cl2
- Alkalinity: 11.8 mg/L as CaCO3
- Conductivity: 180 - 183 µS/cm
- Total ammonia (NH3-N): 0.02 mg/L
- pH: 7.34 - 7.63
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

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

EFFECT PARAMETERS MEASURED: Mortality and symptoms of toxicity were observed daily.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

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.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: No mortality was observed.
- Effect concentrations exceeding solubility of substance in test medium: Test concentration exceeded the water solubility of the test substance.

Description of key information

No toxic effects to fish up to the limit of water solubility (WS: < 0.05 mg/L; OECD 203).

Additional information

In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally similar analogue substancesdipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) and isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 844-63-3) was conducted to fulfil the data requirementsaccording to Annex VII-IX ofcarboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52 -1) in regard to toxicity to fish.

This read-across is justified in detail in the overall summary (IUCLID section 6.1) and within the analogue justification in IUCLID section 13. Both source substances consist of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C9iso and C5,9iso for the source substances, respectively).

The first study with the read across substance dipentaerythritol with fatty acids, C5 and C9iso was performed according to OECD 203 under GLP conditions (Wetton and Mullee, 2000). The rainbow troutOncorhynchus mykisswas exposed to a water accommodated fraction (WAF) with a nominal concentration of 100 mg/L in a semi-static test for 96 h. The test substance concentration was analysed using GC-analysis and resulted in a concentration of < 0.00613 mg/L (limit of quantification). No mortality and no signs of intoxication were observed resulting in a LL50 of > 100 mg/L (nominal).

The second read-across substance isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol was tested according to OECD 203 under GLP conditions (Comber, 1993). Rainbow troutOncorhynchus mykisswas exposed to a nominal concentration of 1000 mg/L in a semi-static test for 96 h. No analytical monitoring was performed. No mortality and no signs of intoxication were observed. Therefore, this study resulted in a LC50 of > 1000 mg/L (nominal). The NOEC was derived to be ≥ 1000 mg/L (nominal).

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded thatC5-9, hexaesters with dipentaerythritolwill not exhibit toxic effects to fish up to the limit of water solubility.