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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Jan - 16 Jan 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no purity)

Qualifier:

according to guideline

Guideline:

other: OECD 202 "Daphnia sp, Acute Immobilisation Test and Reproduction Test" (1984)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom (date of inspection 28 Feb 2000)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Water samples were taken from the control (replicates R1-R2 pooled) and the 1000 mg/L loading rate WAF test group (replicates R1-R2 and R3-R4 pooled) at 0 and 48 h.
- Sample storage conditions before analysis: Duplicate samples of the 1000 mg/L loading rate WAF test groups at 0 h were taken and stored frozen (approx -20°C) for further analysis if necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of test material (10 g) was added to the surface of 10 L of reconstituted water to give a 1000 mg/L loading rate. After the addition of the test material, the reconstituted water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a slight dimple at the water surface. This was stirred for 23 h. After stirring the mixture was allowed to stand for 1 h. The aqueous phase was removed by mid-depth siphoning (the first 75-100 mL discarded) to give the 1000 mg/L loading rate WAF. Microscopic inspection of the WAF showed no micro-dispersions or undissolved test material to be present.
- Controls: Reconstituted water
- Evidence of undissolved material: no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: 1st instar of an in-house laboratory culture
- Age at study initiation: < 24 h
- Method of breeding: Adult Daphnia were maintained in polypropylene vessels containing approx. 2 L of reconstituted water in a temperature controlled room at 21 °C. The lighting cycle was 16 h light and 8 h dark. Each culture was fed daily with a suspension of algae (Chlorella sp.). Reproduction was by parthenogenesis.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

21.8 °C (0 h), 20.6 °C (24 h), 20.8 °C (48 h)

pH:

7.6-7.9

Dissolved oxygen:

90-98%

Nominal and measured concentrations:

Nominal: control - 1000 mg/L
Measured: < Limit of quantification (0.032 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass jars containing approx. 200 mL of test preparation
- Type: covered to reduce evaporation
- No. of organisms per vessel: 10
- No. of vessels per concentration: 4
- No. of vessels per control: 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water

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

EFFECT PARAMETERS MEASURED: Immobilisation was recorded after 24 and 48 h test duration.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10, 100, 1000 mg/L (WAFs)
- Results used to determine the conditions for the definitive study: No immobilisation was observed.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: no mortality was observed in the controls
- Effect concentrations exceeding solubility of substance in test medium: The nominal concentration of 1000 mg/L exceeded the water solubility of the test item.

No effects were observed in the range of water solubility at a nominal concentration of 1000 mg/L (WAF). Analysis of the test preparations at 0 and 48 h showed the measured test concentrations to be less than the limit of quantification of the analytical method (< 0.032 mg/L) (Table 1).

Table 1: Chemical analysis of the test loading rates

Samples	Nominal loading rate [mg/L]	Concentration found [mg/L]
0 h	control	< LOQ
	1000 R1-R2	< LOQ
	1000 R3-R4	< LOQ
48 h	control	< LOQ
	1000 R1-R2	< LOQ
	1000 R3-R4	< LOQ

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 Aug - 06 Nov 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A WAF of nominal loading rate of 100 mg/L was prepared by adding 200 mg test substance to 2 L deionized reverse osmosis water. The mixture was stirred for 23 hours and mixture allowed 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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: bred at the testing facility
- Age at study initiation: < 24 hours
- Feeding during test: none

ACCLIMATION
- Acclimation period: yes
- Type and amount of food: algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
- Feeding frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/L CaCO3

Test temperature:

21 - 22 °C

pH:

7.9 - 8.1

Dissolved oxygen:

8.3 - 8.6 mg/l

Nominal and measured concentrations:

loading rate: 100 mg/L (WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass jars(250 mL)
- Type (delete if not applicable): open / closed
- Material, size, fill volume: glass, 200 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Conductivity: <5 μS cm-1
- Intervals of water quality measurement: water temperature daily, O2 concentration and pH at start and termination of the test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day-night regime
- Light intensity: 647 - 980 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mobility was recored after 24 and 48 hours after test start

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1.0, 10 and 100 mg/L (nominal loading rate, WAF)
- Results used to determine the conditions for the definitive study: EL50 (48 h) > 100 mg/L (WAF)

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mobility

Results with reference substance (positive control):

The positive control was conducted between 6 June 2012 and 8 June 2012. An EC50 (48 h) of 0.45 mg/L was reported.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

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

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mobility

Remarks on result:

other: source, RA-A, CAS 68440-09-5, Harlan, 2012, D. magna, 48 h

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Remarks on result:

other: source, RA-A, CAS 131459-39-7, Safepharm, 2003, D. magna 48 h

Conclusions:

The substance will not exhibit short-term effects to aquatic invertebrates 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 aquatic invertebrates 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) and 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was conducted.

The source substances are representative to evaluate the short-term toxicity of the target substance to aquatic invertebrates. 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 study with the source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) was performed in a static test design according to OECD 202 (GLP).Daphnia magnawere exposed to a single nominal loading rate of 100 mg/L (prepared as WAF). No immobility was observed after an exposure period of 48 h. Hence an EL50 (48 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 static test design according to OECD 202 and EU method C.2 (GLP).Daphnia magnawere exposed to a single nominal loading rate of 1000 mg/L (prepared as WAF). No immobility was observed after an exposure period of 48 h. Hence an EL50 (48 h) of > 1000 mg/L and a NOELR of ≥ 1000 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 aquatic invertebrates is expected up to the limit of the water solubility (< 0.15 mg/L).