Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

07 December 2012 to 14 December 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The analogue approach is used for the hazard assessment of toxicological endpoints for the registration of the target substance trimethylolpropane ricinoleate (CAS 68551-65-5) based on generation of different breakdown/metabolic products, resulting not only in similar physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2015) but also consequently in similar physico-chemical, environmental fate and ecotoxicological properties. The source compounds are fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) and pentaerythritol ricinoleate (CAS 78-22-8). It is proposed that the different alcohols resulting from ester hydrolysis of the source compounds and the target substance will not result in significant variation in environmental or biological effects.
Neither target nor source compounds are classified for hazardous effects associated with aquatic toxicity. The use of reliable experimental data, all evaluated as reliable according to Klimisch scores of 1 or 2, to estimate the ecotoxicity of the registered substance is adequate for the purposes of fulfilling the data requirements of registration and classifying potential hazards. Similar grouping into categories has been accepted by other regulatory agencies (U.S. EPA, 2010; U.S. FDA for food notifications). Thus, this read-across approach is adequate for the purposes of risk assessment and classification and labeling.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

yes

Remarks:

The temperature range during the test was higher than stated in the study plan and the 72 hours stirred solution was used unfiltered. Since no fish died during the test, these deviations did not affect test validity.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

yes

Remarks:

The temperature range during the test was higher than stated in the study plan and the 72 hours stirred solution was used unfiltered. Since no fish died during the test, these deviations did not affect test validity.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

The test substance is listed as Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol. The yellow to amber test substance was identified as a reaction product between pentaerythritol and fatty acids of C16 and C18, linear, mainly C18 unsaturated (commercial oleic acid). The test substance was stored in a dry, closed vessel in the dark at room temperature.

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

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

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test organisms were sexually immature Danio rerio HAMILTON-BUCHANAN 2 ± 1 cm long. The animals were obtained from a commercial supplier, Dehner Garten Center, 67433 Neustadt. Before being used for the test, the fish were kept for 14 days under test conditions. During this period, mortality didn't surpass 5 %.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Hardness of drinking water used in the test was 1.08 mmol/L.

Test temperature:

The temperature of the test medium was 23 ± 2 °C (deviation within the test ± 1 °C).

pH:

The pH values throughout the test were 7.8 – 8.3.

Dissolved oxygen:

The dissolved oxygen was 7.6 to 9.7 mg/L (92%).

Nominal and measured concentrations:

The experimental limit test was performed with a water accommodated fraction (WAF) of the test item at the nominal loading of concentration of 100 mg/L.

Details on test conditions:

The main study was performed as limit test using the concentration 100 mg/L. The concentration showed no mortality. No fish died in the control. At the beginning and at the end of the test, the content of the test item in the test solutions was determined using DOC-determination. The measured DOC values in the treatments and in the control were in the same range. This might be caused by the very low solubility of the test item. Therefore, the determination of the biological results was based on the nominal loadings. No observations were made which might cause doubts concerning the validity of the study outcome. The result of the test is considered valid.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

Biological results were based on nominal loadings since DOC values in the treatments and control were in the same range due to low solubility.

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.

Remarks:

Biological results were based on nominal loadings since DOC values in the treatments and control were in the same range due to low solubility.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Remarks:

Control mortality 0 fish (protocol ≤ 1 fish); Dissolved O2 above 7.6 mg/L or 92% (protocol >60%); pH 7.8 – 8.3 with highest variation 0.5 (protocol not vary > 1 unit).

Conclusions:

Exposure of Danio rerio to a 100 mg/L WAF of the test item showed no mortality. The 96-h NOELR was reported as ≥ 100 mg/L and the 96-h LLR50 was reported as > 100 mg/L.

Description of key information

The key study was a static acute fish toxicity test on the effects of an analogue substance on the freshwater fish Danio rerio following OECD Guideline 203. Exposure of Danio rerio to a 100 mg/L WAF of the test item in a limit test showed no mortality. The 96-h NOELR was reported as ≥ 100 mg/L and the 96-h LLR50 was reported as > 100 mg/L. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L