Fatty acids, C5-9, hexaesters with dipentaerythritol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

23 Mar - 25 Mar 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: OECD guideline 202 "Daphnia sp., Acute immobilisation Test and Reproduction Test" (1984)

Deviations:

no

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 23 Mar 1998)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control - 100 mg/L
- Sampling method: Water samples were taken from the control and the 100 mg/L loading rate WAF test group (replicates R1-R2 and R3-R4 pooled) at 0 and 48 h. Duplicate samples were taken at each occasion.
- Sample storage conditions before analysis: stored frozen (approx. -20 °C) for further analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of test material (500 mg) was added to the vortex of 5 L of reconstituted water and stirred for 23 h to give the 100 mg/L loading rate. The stirring was stopped after 23 h and the mixture allowed to stand for 1 h. The water accommodated fraction (WAF) was then removed by filtration through 0.45 µm filters to give the 100 mg/L loading rate WAF.
- Controls: The control group was maintained under identical conditions but not exposed to the test material.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: supplied by the Institut National de Recherche Chimique Appliquée (IRCHA), France
- 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 with a 16 h light and 8 h darkness cycle with 20 min dawn and dusk transition periods. The cultures were fed with a suspension of mixed algae (predominantly Chlorella spp.). Culture conditions ensured that reproduction was by parthenogenesis.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

21 °C

pH:

7.9-8.0

Dissolved oxygen:

8.0-8.3 mg O2/L

Nominal and measured concentrations:

Nominal concentrations: 100 mg/L loading rate WAF

Details on test conditions:

TEST SYSTEM
- Test vessel: jar
- Type: covered to reduce evaporation
- Material: glass; Size: 250 mL; Fill volume: 250 mL
- 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 darkness cycle with 20 min dawn and dusk transition periods

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

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 and 100 mg/L loading rate 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.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(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:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: No mortality was observed
- Effect concentrations exceeding solubility of substance in test medium: The effect concentration exceeded the water solubility of the test substance.

No effects in the range of water solubility on immobilisation of Daphnia magna were observed after the study period of 48 h. This resulted in an EL50 of > 100 mg/L (nominal). Chemical analysis of the 100 mg/L loading rate WAFs at 0 and 48 h showed the measured test concentrations to be less than or at the limit of quantification of the analytical method. Increasing the time of stirring to 192 h did not result in a significant increase in the amount of carbon in the WAF with respect to the control values.

Table 1: Chemical analysis of test loading rates

Samples	Nominal loading rate [mg/L]	Concentration found [mg/L]
0 h	control	< LOQ
	100 R1-R2	< LOQ
	100 R3-R4	0.00613
48 h	control	< LOQ
	100 R1-R2	< LOQ
	100 R3-R4	< LOQ

Description of key information

No toxic effects to invertrbrates up to the limit of water solubility (WS: < 0.05 mg/L; OECD 203).

Additional information

In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally similar analogue substancesdipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) andfatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1)was conducted to fulfil the data requirementsaccording to Annex VII-IX ofcarboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52 -1) in regard to toxicity to invertebrates.

This read-across is justified in detail in the overall summary (IUCLID section 6.1) and within the analogue justification in IUCLID section 13. The source substances consist of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C5,9iso and C7-10 for the source substances, respectively).

The short-term toxicity to aquatic invertebrates with read across fatty acids C5-10 esters with dipentaerythritol was investigated according to OECD 202 using Daphnia magna as test organism under semi-static conditions. A nominal test concentration of 1060 mg/L (prepared as WAF) was tested. Analytical monitoring was not performed. No immobilisation was observed in the treatment throughout the test period of 48 h. Hence, the 48 h-EL50 is determined to be > 1060 mg/L. It can therefore be concluded that the test substance will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.

The study with the read across substancedipentaerythritol with fatty acids, C5 and C9iso was conducted under static conditions according to OECD 202 using Daphnia magna as test organism. Nominal concentration of 100 mg/L (prepared as WAF) was tested. Analytical monitoring showed that the measured test concentration was less than the limit of quantification. After 48 h no effects were observed. No mortality and no signs of intoxication were observed. Therefore, this study resulted in a 48 h EL50 of > 100 mg/L (nominal). The NOELR was derived to be ≥ 100 mg/L (nominal).

Based on the results from the substance itself and from a structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that fatty acids C5-10 esters with dipentaerythritol will not exhibit toxic effects to invertebrates up to the limit of water solubility.