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Short-term toxicity to aquatic invertebrates

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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:
other: OECD 202 "Daphnia sp, Acute Immobilisation Test and Reproduction Test" (1984)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)
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

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:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)
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.
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:
read-across source
Reason / purpose:
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.

Description of key information

Key value for chemical safety assessment

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).