Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb. 2017 to 02 Mar. 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

OECD Guideline for Testing of Chemicals No. 202, adopted 13. Apr. 2004: ”Daphnia sp., Acute Immobilisation Test“

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Council Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immobilisation Test”, adopted 30. May 2008

Deviations:

no

Principles of method if other than guideline:

OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES, adopted 14. Dec. 2000

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

No further details specified in the study report.

Analytical monitoring:

yes

Details on sampling:

DOC (dissolved organic carbon) was determined as TC (total carbon) minus IC (inorganic carbon) in the filtrated (0.45 μm filtration during preparation of the WAF) test solutions.

Vehicle:

no

Details on test solutions:

The water-accommodated fraction was prepared for the test. This was done by weighing the nominal load 100 mg/L, (real load 100.5 mg/L) adding the corresponding amount of dilution water and shaking vigorously for 25 hours. The resulting solution was filtrated through 0.45 μm PTFE filters.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna
Variety: STRAUS
Strain: Berlin
Sex: female
Age: between 0 and 24 hours
Origin: Umweltbundesamt Berlin
In-house breeding since: 27. September 2007
Selection of the test system was made following the proposal of the guidelines.

Animal Husbandry
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
The husbandry is performed similar to the method described in the OECD guideline, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), Version 12 from 02. Feb. 2015.
Vessels: preserving glasses, nominal volume 2 L
Medium: M4-Medium (recipe of ELENDT)
Food: unicellular green algae (Desmodesmus subspicatus)
Medium renewal: twice a week
Photo period: 16/8 hours, using neon tubes
Temperature: 20 ± 2 °C

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No post exposure observation period specified in the study report.

Hardness:

250 mg CaCO3/L

Test temperature:

20 ± 2 °C

pH:

7.7

Dissolved oxygen:

8.1 - 8.5 mg/L

Salinity:

Not applicable.

Conductivity:

Not specified

Nominal and measured concentrations:

The study was performed as a limit test using 1 concentration of 100 mg/L nominal concentration.

Details on test conditions:

Selection of Daphnia
23 hours before the start of the test, the adult animals were separated from the young. 2 hours before test start, the adults were caught with the help of a glass tube, and the newborn Daphnia, aged between 0 and 23 hours, were sieved from the medium and immediately placed into a 250 mL-beaker containing dilution water. After a settling-in period of 120 minutes, animals which showed no apparent damage were used for the test.
Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test Daphnia.

Study Performance
Using a glass tube, the Daphnia were caught and lifted from the beaker. They were put on a small sieve, and the medium surrounding the animals was sucked off using absorbent paper. Immediately after that, the animals were put into the respective test solution.
The test vessels were left to stand for 48 hours. After 24 and 48 hours, the immobilised Daphnia were counted. Daphnia are considered immobilised if they perform no movements or are only able to move their antennae when the beaker is gently agitated. Daphnia which are trapped at the surface of the test solution are also considered immobilised.
The pH, the concentration of dissolved oxygen and the DOC in the test vessels were measured at the beginning and at the end of the test.
All values were documented in the raw data.

Experimental Conditions
Date of performance: 28. February – 02. March 2017
Treatments: 101 mg/L
Temperature: 19.8 – 21.8 °C
Duration: 48 hours
Observation times: 24 and 48 hours
Medium renewal: none
Test vessels: glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments): 4 vessels, each containing 20 mL test solution and 5 Daphnia
Replicates (Blank control): 4 vessels, each containing 20 mL dilution water and 5 Daphnia

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

In this study no toxicity was observed and no dissolved test item could be detected. In another study, an algal test according to OECD 201 preparation of the test solution was identic.
However, in the algae study at the loading rate 100 mg/L slight inhibition of algal growth was observed which indicates the presence of a very low concentration of dissolved test item in the test solution. That means in the daphnia study also dissolved test item was presence, but not measurable and not toxic against the daphnia.
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

Reported statistics and error estimates:

Not specified

Immobility

Nominal Concentration in mg/L	Immobility 24 hours				Immobility 48 hours
	Absolute			In %	Absolute			In %
Blank control	0	0	0	0	0	0	0	0
100	0	0	0	0	0	0	0	0

 

pH and O₂values

Nominal Concentration in mg/L	pH		O2Concentration in mg/L
	0 h	48 h	0 h	48 h
Blank control	7.7	7.5	8.5	8.2
100	7.0	6.8	8.5	8.1

 

Measured Concentrations IC and TC

Nominal Concentration Test Item	Measured TC t = 0 h	Measured TC t = 48 h	Measured IC t = 0 h	Measured IC t = 48 h
mg/L	mg/L	mg/L	mg/L	mg/L
Blank control	1.15	3.89	1.37	1.37
100	0.90	3.86	1.09	1.19

LOQ (limit of quantification) TC = 0.76 mg/L

LOQ (Limit of quantification) IC = 1.04 mg/L

 

Measured Concentrations DOC

Nominal Concentration Test Item	Measured DOC (TC-IC) t = 0 h	Measured DOC (TC-IC) t = 48 h	Measured DOC minus blank control t = 0 h	Measured DOC minus blank control t = 48 h
mg/L	mg/L	mg/L	mg/L	mg/L
Blank control	0	2.52	--	--
100	0	2.67	0	0.15

 

Biological Results Test Item

Parameter	Value
24h EC50	> 100 mg/L
48h EC50	> 100 mg/L
48h NOEC	> 100 mg/L
48h LOEC	> 100 mg/L

 

Validity criteria fulfilled:

yes

Conclusions:

One valid experiment was performed.
The study was performed as a limit test using 1 concentration of 100 mg/L nominal concentration. 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.
The concentration showed no toxicity. None of the animals were immobilised in the blank control.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
At the start and at the end of the test, the content of dissolved organic carbon (DOC) in the test solutions was determined. The content of DOC in the treatment was in the same range as the blank control. Due to the marginal difference of the DOC concentration in the treatments and the blank control, no test item concentration was calculated based on the organic carbon content of the test item and measured DOC concentrations. Therefore, determination of the biological results was based on the nominal concentrations.
The following results were determined for the test item Hatcol 3178 (species: Daphnia magna).
48h-NOEC ≥ 100 mg/L
48h-LOEC > 100 mg/L
24h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L

Executive summary:

One valid experiment was performed.

The study was performed as a limit test using 1 concentration of 100 mg/L nominal concentration. 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

The concentration showed no toxicity. None of the animals were immobilised in the blank control.

 

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

 

At the start and at the end of the test, the content of dissolved organic carbon (DOC) in the test solutions was determined. The content of DOC in the treatment was in the same range as the blank control. Due to the marginal difference of the DOC concentration in the treatments and the blank control, no test item concentration was calculated based on the organic carbon content of the test item and measured DOC concentrations.

Therefore, determination of the biological results was based on the nominal concentrations.

 

Due to the low solubility of the test item, the measured DOC concentrations in the treatment and in the control were in a similar range.

Due to the marginal difference of the DOC concentration in the treatments and the control, no test item concentration was calculated based on the organic carbon content of the test item and measured DOC concentrations.

Therefore, the determination of the results was based on the nominal concentrations.

This is in agreement with the OECD guidance document no. 23, where is stated: “For tests with chemicals that cannot be quantified by analytical methods, the effect concentration can be expressed based on the nominal concentrations (loading rates)”.

In this study no toxicity was observed and no dissolved test item could be detected. In another study, an algal test according to OECD 201 preparation of the test solution was identic.

However, in the algae study at the loading rate 100 mg/L slight inhibition of algal growth was observed which indicates the presence of a very low concentration of dissolved test item in the test solution. That means in the daphnia study also dissolved test item was presence, but not measurable and not toxic against the daphnia.

No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.

The result of the test is considered valid.

 

The following results were determined for the test item Hatcol 3178 (species: Daphnia magna).

48h-NOEC ≥ 100 mg/L

48h-LOEC > 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 > 100 mg/L

Description of key information

The following results were determined for the test item Hatcol 3178 (species: Daphnia magna).

48h-NOEC ≥ 100 mg/L

48h-LOEC > 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 > 100 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

One valid experiment was performed.

The study was performed as a limit test using 1 concentration of 100 mg/L nominal concentration. 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

The concentration showed no toxicity. None of the animals were immobilised in the blank control.

At the start and at the end of the test, the content of dissolved organic carbon (DOC) in the test solutions was determined. The content of DOC in the treatment was in the same range as the blank control. Due to the marginal difference of the DOC concentration in the treatments and the blank control, no test item concentration was calculated based on the organic carbon content of the test item and measured DOC concentrations.

Therefore, determination of the biological results was based on the nominal concentrations.

No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.

 

The following results were determined for the test item Hatcol 3178 (species: Daphnia magna).

48h-NOEC ≥ 100 mg/L

48h-LOEC > 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 > 100 mg/L