2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

see chapter 13 read-across justification

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: The test substance induced no lethal or other visible effects in carp at 100 mg/L (nominal).
- Any observations that might cause a difference between measured and nominal values: Test substance drops floating at the surface of the medium after 48 h test duration in all tested concentrations of the range-finding test (1.0, 10, 100 mg/L [nominal]) and from the beginning in the the final test (100 mg/L [nominal]). Additionally, substance deposits at the bottom of the vessel were observed after 48 h test duration in the 100 mg/L treatment of the range-finding test.

Results with reference substance (positive control):

- Results with reference substance valid? Yes, because the range of the LC50 (96h) for carp is generally between 0.10 and 0.46 mg/L based on
historical data of reference tests approximately every 3 months since April 1988.
- LC50: The LC50 (96h) = 0.14 mg/L (0.13 - 0.18 mg/L 95% CI)

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

see chapter 13 read-across justification

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: The surviving fish did not show any abnormal behaviour.

Sublethal observations / clinical signs:

No control was applied during this test. However, as no mortality were observed at both tested concentrations, the test results are considered usable for regulatory purposes.

 

Table 1: Mortality of Brachydanio rerio (n.d. = not determined)

Concentration [mg product/l]	Incubation time [h]
	0	6	24	48	72	96
3000	0	0	0	0	n.d.	0
10000	0	0	0	0	n.d.	0

 

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

see chapter 13 read-across justification

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Details on results:

No mortality observed.
- Behavioural abnormalities: none
- Mortality of control: none
-

Sublethal observations / clinical signs:

DOC analysis of the test substance concentration was conducted at test start and after 96 hours at the end of exposure. The DOC concentration measured in the test solution at test start was 0.04 mg/L; at test termination 0.83 mg/L were determind. In the control vessels a concentration of 2.02 mg/L at test start and 1.74 mg/L at test termination was measured. Thus, the substance can be considered as not soluble in the test medium. Therefore the evalution is based on nominal concentrations.

Description of key information

No toxic effects to fish up to the limit of water solubility (< 0.05 mg/L).

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 read across to three structurally related sub-category members pentaerytritol tetraoleate (CAS 19321-40-5), 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) and fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1)was conducted to fulfill the data requirement according to Annex VII-IX offatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) in regard to the short term toxicity to fish,. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. The fatty acid chain length of C16 and C18 of the read-across substances are identical to those of the target substance and all substances contain the same alcohol (pentaerythritol).

The first study with the read-across substance pentaerytritol tetraoleate (CAS 19321-40-5) was performed under static conditions and GLP according to OECD 203 (Bogers, 1997).Cyprinus carpiowas exposed to a nominal concentration of 100 mg/L. A stock solution was prepared in acetone. Blank and solvent controls were also tested. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 100 mg/L. Therefore it can be concluded that pentaerytritol tetraoleate (CAS 19321-40-5) will not exhibit short-term effects to fish up to the limit of water solubility.

For the second read-across substance 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) a test under semi-static conditions according to ISO 7346-1 was performed (Richterich, 2008).Brachydanio rerio (new name Danio rerio) was exposed to nominal concentrations of 3000 and 10000 mg/L. The test substance was weighed directly into the vessels, filled up with water and stirred. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 10000 mg/L (nominal). Therefore it can be concluded that 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) will not exhibit short-term toxicological effects to fish up to the limit of water solubility.

For the third read-across substance fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) a test under static conditions according to OECD 203 was performed (Muckle, 2013).Danio rerio was exposed to a nominal concentration of 100 mg/L. A water accommodated fraction (WAF) was prepared by adding the required amount of test substance to water with subsequent stirring. The lower phase was used as test medium. DOC analysis of the test substance concentrations indicated that the substance is not soluble in the test medium and the evaluation is hence based on nominal concentrations. No mortalities occurred after the test duration of 96 hours resulting in an LL50 of > 100 mg/L (nominal).

Based on the acute fish toxicity studies on read-across substance, it can be concluded that 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) will not exhibit short-term toxicological effects to fish up to the limit of water solubility.