Fatty acids, C16-18, Me esters

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:

insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

3.367 mg/kg sediment dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

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

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006"General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances…This avoids the need to test every substance for every endpoint”.

Since the group concept is applied to the members of the SCAE Me category, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

 

Classification related key information

Biodegradation in water: screening tests:   87% in 28 days (BODIS Test, based on OECD 301D)(read-across).

 

Bioaccumulation: No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3).

 

Acute toxicity:

Fish:   

LC50 (96 h)(Danio rerio): 550 mg/L (nominal, above the water solubility value of the substance, < 1 mg/L)(read-across)(ISO-7346-1)

LC50 (48 h)(Leuciscus idus): 5500 mg/ L (nominal, above the water solubility value of the substance, < 1 mg/L) (read-across)(DIN 38412/15)

Aquatic invertebrates:

EC50 (48 h)(Daphnia magna): > 0.02 mg/L (measured initial concentration) (read-across)(OECD 202)

EC50 and EL50 (48 h)(Daphnia magna): > 100 mg/L (nominal and loading rate)(read-across)(EU C.2)     

EL50 (48 h)(Acartia tonsa): > 1000 mg/L (nominal loading rate)(read-across)(ISO proposal)

Algae:

EC50 (72 h)(Pseudokirchneriella subcapitata): > 0.023 mg/L (measured TWA concentration)(read-across)(OECD 201)

 

Chronic toxicity:

Aquatic invertebrates:

NOEC (21d)(Daphnia magna): ≥ 0.22 mg/L (measured TWA concentration)(read-across)(OECD 211)

Algae:

NOEC (72 h)(Pseudokirchneriella subcapitata): ≥ 0.023 mg/L (measured TWA concentration)(read-across)(OECD 201).

 

Non-classification justification according to CLP and DSD

Based on the data above, Fatty acids, C16-18, methyl esters (CAS No. 85586-21-6) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute and chronic aquatic toxicity data available showed no toxic effects on fish, daphnids and algae up to the highest attainable concentrations in test medium, and therefore effect concentrations (L(E)C50 and NOEC values) could not be determined. Considering this information, Fatty acids, C16-18, methyl esters does not need to be classified and labeled as environmental hazard according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC.