Octanoic acid, monoester with glycerol

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:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

EG guideline 84/449/EWG

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The poorly soluble test substance was added to synthetic freshwater at 1 g/L and stirred for 18 hours. Afterwards the solution was filtrated. This solution was used as stock solution. The DOC content was determined to be 2.95 mg/L, equivalent to a test substance content of 4.38 mg/L.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea
- Strain: Straus, clone 5
- Source: own breeding
- Age at study initiation: < 24 hours
- Method of breeding: parthogenetic reproduction
- Feeding during test: none

ACCLIMATION/CULTURE
- Culture conditions: M4 medium according to Elendt, 1 L beakers
- Type and amount of food: Scenedesmus subspicatus, as much as they eat
- Feeding frequency: daily
- Health during acclimation: healthy, darkbrown colour

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 +/- 1°C

pH:

7.6 - 8.1

Dissolved oxygen:

7.5 - 7.6 mg/L

Nominal and measured concentrations:

Nominal concentrations: 0.53, 0.70, 1.01, 1.40, 2.01, 2.80, 3.94 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Beakers filled with 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 2 mL per test organism


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater (CaCl2xH2O: 294 mg/L; MgSO4x7H2O: 123 mg/L; NaHCO3: 63 mg/L; KCl: 5.5 mg/L)


OTHER TEST CONDITIONS
- Photoperiod: dark



EFFECT PARAMETERS MEASURED: Immobilisation, after 24 and 48 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: < 2

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.94 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: No effect up to the limit of the water solubility of the test substance was observed.

Details on results:

- Mortality of control: none
- Any observations that might cause a difference between measured and nominal values: No, as stock solution was filtered and thus, the highest tested concentration was the highest water soluble concentration of the test substance.

No effect up to the limit of the water solubility of the test substance was observed.

Table 1: Cumulative numbers of immobilised individuals during the test, absolute and % readings

Concentration (mg/L)	24h values			48h values
	mobile	immobile	immobile %	mobile	immobile	immobile %
Control	20	0	0	20	0	0
0.53	20	0	0	19	1	5
0.70*	21	0	0	21	0	0
1.01	19	1	5	19	1	5
1.40	20	0	0	20	0	0
2.01*	21	0	0	21	0	0
2.80	20	0	0	20	0	0
3.94	19	1	5	19	1	5

* 21 daphnids used in test

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

8. to 10. November 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

. Additionally consideration of the "VCI-Konzept-Entwurfes für die (akute) aquatische Prüfung von schwerlöslichen Stoffen vom 31.1. 1994"

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: both test runs (a) directly weighed in and b) separated from undissolved test substance and)
- Sampling method: Samples were taken at 0 and 48 hours

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to the low solubility of the test substance, two different test solutions were prepared according to the VCI-concept for poorly soluble substances.
a) 100 mg/L directly weighed in solution: The test substance was directly weighed into the vessel and ultrasonicated for 5 min.
b) Test solution with 100 mg/L and subsequently separation of unsolved test substance: 100 mg test substance were added to 1 L M4 medium and stirred for 24h. Afterwards the unsolved test substance was separated by filtration with a fibre glass filter (pretreated with 1 molar NaOH).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: STRAUS
- Source: BGA Berlin (May 1994) afterwards own breeding
- Age at study initiation (mean and range, SD): 6 - 24h
- Feeding during test: none


ACCLIMATION
- Type and amount of food: Scenedesmus subspicatus

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

21.8°C

pH:

7.8 - 7.9

Dissolved oxygen:

94% oxygen saturation

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentrations:
Test solution a) directly weighed in without separation: 0h = 79.33 mg/L; 48h = 26.76 mg/L
Test solution b) separation of undissolved matter: 0h = 2.33 mg/L; 48 h = 0.08 mg/L The recovery of the test substance at the beginning and after 48 hours was higher than the water solubility of the test substance determined with the column elution method, what means that the separation was not complete.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL glass beaker, covered with a glass disc and filled with 50 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 5 mL per daphnia


TEST MEDIUM / WATER PARAMETERS
- Test medium: M4-medium according to guideline


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours


EFFECT PARAMETERS MEASURED: Immobilisation


TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test - only 100 mg/L

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: solution a) test substance directly weighed in without separation of undissolved matter

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.01 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: solution b) separation of undissolved matter: No effect up to the limit of the water solubility of test substance (< 0.01 mg/L).

Details on results:

- Mortality of control: none
- Any observations that might cause a difference between measured and nominal values: Yes, for solution a) a turbidity of the test suspension was observed.
- Effect concentrations exceeding solubility of substance in test medium: yes, for solution a) without separation of undissolved test substance

No effect was observed up to the limit of the water solubility of the test substance under conditions tested. For the test solution a) without the separation of the undissolved test substance, an immobilisation of 20 to 30% (mean 25%) was observed.

Table 1: Immobilisation (%) of daphnids in solution a) (without separation of undissolved test substance)

Concentration (mg/L)	Incubation time (h)
	24	48
0/1	0	0
0/2	0	0
100/1	0*	20*
100/2	10*	30*

*Daphnia swimming on the surface, caught in oil drops. A turbidity of the test suspension was observed.

 

Table 2: Immobilisation (%) of daphnids in solution b) (with separation of undissolved test substance)

Concentration (mg/L)	Incubation time (h)
	24	48
0/1	0	0
0/2	0	0
100/1	0	0
100/2	0	0

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

8. to 10. November 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

. Additionally consideration of the "VCI-Konzept-Entwurfes für die (akute) aquatische Prüfung von schwerlöslichen Stoffen vom 31.1. 1994"

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: both test runs (a) directly weighed in and (b) separated from undissolved test substance
- Sampling method: Samples were taken at 0 and 48 hours

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to the low solubility of the test substance two different test solutions were prepared according to the VCI-concept for poorly soluble substances.
a) 100 mg/L directly weighed in solution: The test substance was directly weighed into the vessel and ultrasonicated for 5 min.
b) Test solution with 100 mg/L and subsequently separation of unsolved test substance: 100 mg test substance were added to 1 L M4 medium and stirred for 24h. Afterwards the unsolved test substance was separated by filtration with a fibre glass filter (pretreated with 1 molar NaOH).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: STRAUS
- Source: BGA Berlin (May 1994) afterwards own breeding
- Age at study initiation: 6 - 24h
- Feeding during test: none


HOUSING
- Type and amount of food: Scenedesmus subspicatus

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

21.8°C

pH:

7.8 - 7.9

Dissolved oxygen:

at least 90% oxygen saturation

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentrations:
Test solution a) directly weighed in without separation: 0h = 105.36 mg/L; 48h = 44.30 mg/L
b) separation of undissolved matter: 0h = 0.29 mg/L; 48 h = 0.15 mg/L The recovery of the test substance at the beginning and after 48 hours was higher than the water solubility of the test substance determined with the column elution method, what means that the separation was not complete.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL glass beaker, covered with a glass disc and filled with 50 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 5 mL per daphnia


TEST MEDIUM / WATER PARAMETERS
- Test medium: M4-medium according to guideline


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation


TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test - only 100 mg/L

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: solution a) test substance directly weighed in without separation of undissolved matter: No effect up to the limit of the water solubility of the test substance was observed.

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.01 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: solution b) separation of undissolved matter: No effect up to the limit of the water solubility of test substance (< 0.01 mg/L).

Details on results:

- Mortality of control: none
- Any observations that might cause a difference between measured and nominal values: Yes, for solution a). Black particles were observed in the suspension. Partly they adhered on the daphnids. A turbidity of the test suspension was observed.
- Effect concentrations exceeding solubility of substance in test medium: yes, for solution a) without separation of undissolved test substance

No effect was observed up to the limit of the water solubility of the test substance under conditions tested. Furthermore no effects were observed in an oversaturated solution with undissolved test substance.

Table 1: Immobilisation (%) of daphnids in solution a) (without separation of undissolved test substance)

Concentration (mg/L)	Incubation time (h)
	24	48
0/1	0	0
0/2	0	0
100/1	0*	10*
100/2	10*	10*

*Black particles were observed in the suspension. Partly, they adhered on the daphnids. A turbidity of the test suspension was observed.

 

Table 2: Immobilisation (%) of daphnids in solution b) (with separation of undissolved test substance)

Concentration (mg/L)	Incubation time (h)
	24	48
0/1	0	0
0/2	0	0
100/1	0	0
100/2	0	0

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13.-15. October 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L (Limit test)

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg/L of the test substance were weighed into test medium and stirred for one day. Following the stock solution was filtered with a fibre glass filter (pretreated with NaOH). The filtrate was used as test solution.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, not after filtration.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: BioInternational B.V., NJ Horn, the Netherlands
- Method of breeding: Ephippien delivered at 1998-09-03. They were incubated at approx. 20°C with continuous light (approx. 4800 lux) in a M4-Medium (Elendt)
- Feeding during test: none


ACCLIMATION
- Acclimation period: The hatched neonates were kept at approx. 20°C with 16hours light (900 Lux) in a M4-Medium (Elendt).
- Acclimation conditions (same as test or not): yes, same as test conditions
- Type and amount of food: Scenedesmus subspicatus

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20-20.2°C

pH:

8.0

Dissolved oxygen:

92-94% oxygen saturation

Nominal and measured concentrations:

Nominal concentration: 100 mg/L (prepared as WAF)
Measured concentration: Recovery < 1%

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL glass beaker, filled with 50 mL and covered with glass plates
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2


TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: after 48h


OTHER TEST CONDITIONS
- Adjustment of pH: not mentioned
- Photoperiod: 16h light / 8h dark
- Light intensity: approx. 900 lux


EFFECT PARAMETERS MEASURED: Immobilisation after 24 and 48 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test

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.

Basis for effect:

mobility

Remarks on result:

other: No effect up to the limit of the water solubility of the test substance was observed.

Details on results:

- Mortality of control: No
- Other adverse effects control: no
- Effect concentrations exceeding solubility of substance in test medium: yes, but test solution was prepared as Water Accomodated Fraction (WAF) and thus no undissolved test substance was present in test solution.

Results with reference substance (positive control):

The EC50 (24h) with potassium dichromate was between 0.9 and 1.9 mg/L (here 1.4 mg/L) and fulfils therewith the validity criteria.

The test solutions were prepared as Water Accomodated Fraction (WAF) by filtrating the undissolved test material out.

In this test no effect up to the limit of the water solubility of the test substance was observed.

The test report mentions a EC50, but due to the fact that WAFs were prepared a EL50 has to be reported instead.

Reference 5

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:

weight of evidence

Justification for type of information:

refer to category justification provided in IUCLID section 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

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.

Basis for effect:

mobility

Remarks on result:

other: RA CAS 97722-02-6

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.01 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: RA CAS 67701-30-8

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.01 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: RA CAS 65381-09-1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.94 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: RA CAS 620-67-7

Description of key information

No effect on aquatic invertebrates up to the limit of the water solubility of Fatty Acid Glycerides was observed (EC50 > water solubility).

Additional information

The hazard assessment is based on the data currently available. New studies (including long-term studies) with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

 

In order to fulfil the standard information requirements, according to Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

Four short-term studies with Daphnia magna are available for four different substances (CAS 97722-02-6, CAS 67701-30-8, CAS 620-67-7 and CAS 65381-09-1). In all four static studies over 48 hours no effect on Daphnia magna was observed up to the limit of the water solubility of the tested substances.

All four tests were conducted according to EU-Method C.2, which is equivalent to OECD guideline 202. Two of the tests (CAS 67701-30-8 and CAS 65381-09-1) were conducted with additional consideration of the VCI concept for poorly soluble substances. Thus, two different test solutions were prepared: One solution where the test substance was directly weighed into the test vessel and undissolved substance was not removed and a second solution with separation of undissolved substance through filtration (preparation of a Water Accommodated Fraction (WAF)). No effect was observed up to the limit of the water solubility of the tested substances under conditions tested. Furthermore less than 30% of the Daphnids were immobilised in the oversaturated solutions with undissolved test substance. The other two tests (CAS 97722-02-6 and CAS 620-67-7) used filtered test solutions and did not observe effects on Daphnia magna either.

No effect up to the limit of the water solubility for all category members Fatty Acid Glycerides is assumed.