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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

29 January 2013 to 21 February 2013

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 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

Test was repeated with an altered test media prep method WAF to eliminate daphnids sticking to the surface layer of the test media and test was repeated as a limit test with a lower concentration. Changes did not affect test validity.

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

Test was repeated with an altered test media prep method WAF to eliminate daphnids sticking to the surface layer of the test media and test was repeated as a limit test with a lower concentration. Changes 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 test substance was stored in a dry, air-tight container at room temperature.

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organisms were juvenile Daphnia magna Straus. The stock culture was obtained from the German Federal Environment Agency, Institute for Water, Soil, and Air Hygiene (Berlin). Specimens used in the test were bred in the laboratory at Fraunhofer IME.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

1.0 mmol/L

Test temperature:

The temperature of the test medium was 18.5 -19.9°C with less than 2°C variation and complied with the requirements of the protocol (18-22°C, constant within 2°C).

pH:

The pH values throughout the test were within the recommended range at 7.7 - 9.62 and did not deviate by more than 1.5 units.

Dissolved oxygen:

The oxygen saturation was higher than 3 mg/L at all times with a range of 5.8 -9.8 mg/L..

Nominal and measured concentrations:

The experimental test was performed with a water accommodated fraction (WAF) of the test item at the nominal loading of 1.0 mg/L.

Details on test conditions:

Approximately 100 mL of each test medium was added to each replicate test vessel followed by a single D. magna less than 24 h old. The daphnids were exposed to a single WAF loading of the test item under semi-static conditions for a period of 21 days. The test solutions were exchanged daily.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Validity criteria fulfilled:

yes

Remarks:

Control mortality 0.0% (protocol ≤20%); mean offspring at day 21 64.7 (protocol at least 60); O2 5.8-9.8 mg/L (protocol >3%); pH 7.7-9.62 (protocol 6-9 not vary > 1.5); temp. 18.5 -19.0˚C (protocol 18-22 ±2 ˚C); light 501-988 lux (protocol ≤ 1,500 lux).

Conclusions:

Exposure of Daphnia magna to a 1.0 mg/L WAF of the test item had no statistically significant effect on reproduction. Therefore, the NOELR was reported as ≥ 1.0 mg/L.

Description of key information

The key study was a semi-static chronic invertebrate toxicity test on the effects of an analogue substance on the freshwater invertebrate Daphnia magna following OECD Guideline 211. Exposure of Daphnia magna to a 1.0 mg/L WAF of the test item had no statistically significant effect on reproduction. Therefore, the NOELR was reported as ≥ 1.0 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 mg/L