Fatty acids lanolin, di-, tri- and tetraesters with pentaerythritol and rape fatty 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:

key study

Study period:

15 Mar - 19 Mar 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no purity)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

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

Details on sampling:

- Concentrations: Water samples were taken from the control and each replicate test vessel at 0, 24 and 48 hours.
- Sample storage conditions before analysis: Duplicate samples and samples at 24, 48 and 72 hours were taken and stored frozen (approximately -20 °C) for further analysis if necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Prior to addition of the test material, the dechlorinated tap water was stirred by magnetic stirrer such that a vortex depth of approximately 25% of the overall height of the water column was achieved. An amount of test material (2.0 g) was added to the vortex of 20 litres of dechlorinated tap water and stirred for 23 hours to give the 100 mg/L loading rate. The stirring was stopped after 23 hours and the mixture allowed to stand for 1 hour. The WSF was then removed by filtration through 0.45 µm filters.
- Controls: yes, dechlorinated tap water

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, Gloucestershire, UK (in-house since 23 Feb 1999)
- Length at the end of the definitive study (mean and SD): 4.1 cm (SD = 0.1)
- Weight at the end of the definitive study (mean and SD): 0.88 g (SD = 0.14)
- Feeding during test: None

ACCLIMATION
- Acclimation period: from 3 - 15 Mar 1999
- Acclimation conditions (same as test or not): Same as test (14 °C, lighting cycle: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods)
- Type and amount of food: commercial trout pellets
- Feeding frequency: The fish were not fed for 24 h prior to the start of the test.
- Health during acclimation (any mortality observed): No mortality in the 7 days prior to the start of the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

approximately 100 mg/L CaCO3

Test temperature:

14 °C

pH:

7.5 - 7.8

Dissolved oxygen:

8.6 - 9.8 mg/L

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L
measured: < Limit of quantification (0.02 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size: 20 L glass vessels
- Aeration: gentle aeration via narrow bore glass tubes
- Renewal rate of test solution (frequency): every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener). It was then passed through a series of computer controlled plate heat exchanges to achieve the required temperature (14 °C).
- Alkalinity: approximately 100 mg/L as CaCO3
- Intervals of water quality measurement: Daily for pH, dissolved oxygen and temperature.

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities and symptoms of toxicity at 3, 6, 24, 48, 72 and 96 hours. The fish from the control were weighted and measured at the end of the exposure period.

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:

- Observations on body length and weight: Control at the end of the exposure period: mean standard length of 41 mm (SD = 0.1), mean weight of 0.88 g (SD = 0.14)
- Mortality of control: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: At the start of each mixing period the test material was observed to form pale straw coloured oily globules within the vortex and also throughout the water column. After 23 hours of stirring and 1 hour of standing the test material was observed to form an oily slick at the water surface with globules throughout the water column. After filtering and during testing the 100 mg/L loading rate WSFs were observed to be clear, colourless solutions.

Sublethal observations / clinical signs:

Table 1: Cumulative mortality data in the definitive study

Nominal loading rate (mg/L)	Cumulative mortality (initial population)						% mortality
	3 h	6 h	24 h	48 h	72 h	96 h	96 h
Control	0	0	0	0	0	0	0
100 R1	0	0	0	0	0	0	0
100 R2	0	0	0	0	0	0	0

h = hours

R = replicate

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Aug - 11 Sep 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, date of inspection 19 - 21 Jul 2011

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A WAF of nominal loading rate of 100 mg/L was prepared by adding 2100 mg test substance to 21 L deionized reverse osmosis water. The mixture was stirred for 23 hours and mixture was allowed to stand for 1 hour after stirring. The WAF was used as test solution.
- Controls: For TOC analyses two duplicates of WAF were prepared One loading rate was stirred for a period of 23 hours and the other for a period of 95 hours. After a 1-Hour standing period the mixtures were then removed by siphon and samples taken for Total Organic Carbon analysis. The TOC concentrations were below the limit of quantitation (1.0 mg C/L).
- Evidence of undissolved material: no undissolved test item found (microscopic inspection of WAF)

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, Yorkshire, UK
- Age at study initiation: 12 days
- Feeding during test: none

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same
- Type and amount of food: commercial trout pellets
- Health during acclimation: 1% mortality in the 7 days prior to the start of the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

140 mg/L as CaCO3

Test temperature:

14 °C ± 1 °C

pH:

8.0 - 8.1

Dissolved oxygen:

8.6 - 10.1 mg/L

Nominal and measured concentrations:

Nominal loading rate: 100 mg/L (WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass vessels
- Type: covered
- Fill volume: 20 L
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated, softened tap water
- Conductivity: 419 μS/cm at 20°C
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 hours day-night regime

EFFECT PARAMETERS MEASURED:
Mortalities and symptoms of intoxication were determined after 3, 6, 24, 48, 72 and 96 hours after test start


TEST CONCENTRATIONS
- Range finding study: yes
- Results used to determine the conditions for the definitive study: LL50 > 100 mg/L

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

other: toxic effects

Details on results:

- Behavioural abnormalities: no behavioural abnormalities were observed
- Observations on body length and weight: mean standard length 5.0 cm (sd = 0.1), mean weight 1.84 g (sd = 0.09) at test end
- Mortality of control: no mortality observed

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2012 - Jan 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A WAF ( water accommodated fraction) was prepared by adding the required amount of test substance to the dilution water. The mixture was stirred for 72 hours at 100 rpm. The lower phase was used as test medium.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Dehner Garten Center, Neustadt, Germany
- Age at study initiation: sexually immature fish
- Length at study initiation: 2 ± 1 cm
- Feeding during test: none


ACCLIMATION
- Acclimation conditions (same as test or not): yes
- Type and amount of food: warm water fish food and daphnia, 1-2% of body weight
- Feeding frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

1.08 mmol/L

Test temperature:

21.8 - 25 °C

pH:

7.8 - 8.3

Dissolved oxygen:

7.9 - 9.7 mg/L

Nominal and measured concentrations:

Nominal test substance concentration: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquaria
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass, 10 L total volume, 7 L fill volume
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water (Maikammer, Germany)
- Pesticides: < limit of detection
- Conductivity: 330 µS/cm
- Intervals of water quality measurement: pH and oxygen content were measured every 24 hours.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 h day-night regime


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 0, 24, 48, 72 and 96 hours

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Details on results:

No mortality observed.
- Behavioural abnormalities: none
- Mortality of control: none
-

Sublethal observations / clinical signs:

DOC analysis of the test substance concentration was conducted at test start and after 96 hours at the end of exposure. The DOC concentration measured in the test solution at test start was 0.04 mg/L; at test termination 0.83 mg/L were determined. In the control vessels a concentration of 2.02 mg/L at test start and 1.74 mg/L at test termination was measured. Thus, the substance can be considered as not soluble in the test medium. Therefore the evalution is based on nominal concentrations.

Reference 4

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 chapter 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:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 68440-09-5, Harlan, 2012, O. mykiss, 96 h

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate / WAF

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 131459-39-7, Safepharm, 1999, O. mykiss, 96 h

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 85711-45-1, Oleon, 2013, D. rerio, 96 h

Conclusions:

The substance will not exhibit short-term effects to fish up to the limit of water solubility.

Additional information

Since no studies investigating the short-term toxicity of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid to fish are available, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5, a read-across to the structurally related source substances Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5), 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) and Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was conducted.

The source substances are representative to evaluate the short-term toxicity of the target substance to fish. This read-across is justified in detail within the analogue justification in IUCLID Section 13.

The target substance Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is characterized as a UVCB substance with pentaerythritol as alcohol component. Esterification of pentaerythritol gives mainly tri- and tetraesters of long chain fatty acids C16-C20.

The source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) is characterized as a UVCB substance with pentaerythritol as alcohol component. Pentaerythritol is esterified by long chain fatty acids C10-C28.

The source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) is characterized by the alcohol component pentaerythritol. Esterification gives mainly tetraesters of 3,5,5-trimethylhexanoic acid and valeric acid.

The source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) is characterized as a UVCB substance with pentaerythritol as alcohol component. Esterification of pentaerythritol gives a mixed degree of esters of mainly C16-C18 fatty acids.

The study with the source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) was performed in a semi-static test design according to OECD 203 (GLP).Oncorhynchus mykisswere exposed to a single nominal loading rate of 100 mg/L (prepared as WAF). No mortality and no behavioural abnormalities were observed after an exposure period of 96 h. Hence an LL50 (96 h) of > 100 mg/L and a NOELR of ≥ 100 mg/L was determined.

The study with the source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was performed in a semi-static test design according to OECD 203 and EU method C.1 (GLP).Oncorhynchus mykisswere exposed to a single nominal loading rate of 100 mg/L (prepared as WAF). No mortality and no behavioural abnormalities were observed after an exposure period of 96 h. Hence an LL50 (96 h) of > 100 mg/L was determined.

The study with the source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was performed in a static test design according to OECD 203 and EU method C.1 (GLP).Danio reriowere exposed to a single nominal loading rate of 100 mg/L (prepared as WAF). No mortality and no behavioural abnormalities were observed after an exposure period of 96 h. Hence an LL50 (96 h) of > 100 mg/L and a NOELR of ≥ 100 mg/L was determined.

Based on the results for the 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 no toxicity of the target substance Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid to fish is expected up to the limit of the water solubility (< 0.15 mg/L).