Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

no hazard identified

Marine water

Hazard assessment conclusion:

no hazard identified

STP

Hazard assessment conclusion:

no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:

no hazard identified

Sediment (marine water)

Hazard assessment conclusion:

no hazard identified

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The toxicity potential of the substance to the aquatic organisms was evaluated by considering available data on the substance as well as data on two analogue substances. Justification for Read Across is given in Section 13 of IUCLID. The aquatic toxicity studies include the short-term toxicity to fish and to aquatic invertebrates, the toxicity to aquatic algae and the toxicity to microorganisms. For the derivation of the PNECs the effect levels presented below are considered:

Fish

LC50 (96h) > 100 mg/l (nominal)

No mortality was observed in the limit test group and therefore the LC50 was higher than 100 mg/l.

Daphnia

EC50 (48h) = 386 mg/l (mean measured)

NOEC (48h) = 24 mg/l (mean measured)

There was a statistically significant reduction in mobility at 48 h down through the 496 mg/l dose.

Algae

IC50 (96 h) >1000 mg/l (nominal)

NOEC (96h) = 1000 mg/l (nominal)

A significant reduction in algal growth response was not observed in any of the test treatments; therefore, effect levels were higher than the highest tested concentration.

Microorganisms

EC50 (3h)> 1000 mg/l (nominal)

NOEC (3h) =1000 mg/l (nominal)

There was no oxygen uptake from abiotic processes and the results at 1000 mg/l with a nitrification inhibitor showed no heterotrophic inhibition of the respiration rate. The expected EC50 was above the highest concentration tested i.e. 1000 mg/l.

Conclusion on classification

The classification of the substance is evaluated based on available experimental data.

According to the CLP Regulation (EC) No. 1272/2008, Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment (fish toxicity) when the following criteria are met:

A )Acute (short-term) aquatic hazard

Category Acute 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

B) Long-term aquatic hazard

(i) Non-rapidly degradable substances for which adequate chronic toxicity data is available

Category Chronic 1: 96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 0.1 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

(ii) Rapidly degradable substances for which there are adequate chronic toxicity data available

Category Chronic 1:96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 0.01 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 0.1 mg/l

Category Chronic 3: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

(iii) Substances for which adequate chronic toxicity data are not available

Category Chronic 1:96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or, 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 1 to ≤10 mg/l

Category Chronic 3: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 4: Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log K ow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

The substance is not readily biodegradable, is very water soluble, has a LogPow < 4 and is not expected to bioaccumulate based on the predicted BCF value (1.41 l/kg). Considering the available data, no toxic effects were observed under the test conditions for the aquatic organisms besides daphnia. Notwithstanding the absence of toxicity in the rest of the aquatic organisms, all the available data is considered for the evaluation of the classification of the substance: the effect levels for fish and daphnia are above the highest tested concentration while the EC50 for daphnia was determined to be 386 mg/l.

Based on these results no classification for aquatic toxicity is proposed.