Hexadecyl hydrogen maleate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.1 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

1 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.01 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

1 mg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

90.4 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

9.04 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

17.9 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

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. 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) (or higher than its solubility in test medium)

Daphnia

EC50 (48h) > 100 mg/l (nominal) (or higher than its solubility in test medium)

Algae

IC50 (96 h) >1000 mg/l (nominal) (or higher than its solubility in test medium)

Microorganisms

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

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

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, has a LogPow > 4 and presents a predicted BCF value of 10 l/kg. Considering the available data, no toxic effects were observed under the test conditions for the aquatic organisms.

As per the CLP Regulation (EC) No. 1272/2008, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow > 4), indicating a potential to bioaccumulate, should be considered to be classified in Chornic Category 4 for Aquatic Toxicity

Based on these results classification in Aq. Chronic 4 (H413) is proposed.