Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.2 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

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:
26.6 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.66 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:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.6 mg/kg food
Assessment factor:
300

Additional information

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:

78% biodegradation in 28 days (read-across) (OECD 301C)                        

90.4% biodegradation in 28 days (read-across) (OECD 301B)

75% biodegradation in 28 days (read-across) (ISO Draft (BOD Test for Insoluble Substances)

Bioaccumulation:                       

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

 

Acute toxicity:

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

-         Aquatic invertebrates: EC50 (48 h) > 0.16 mg/L for Daphnia magna (OECD 202)

-         Algae: EL50 (72 h) > 100 mg/L for Desmodesmus subspicatus (OECD 201, read across)

 

Chronic toxicity:

-        Aquatic invertebrates: NOELR (21 d) >= 100 mg/L for Daphnia magna (OECD 211, read across)

-         Algae: EL10 (72 h) > 100 mg/L for Desmodesmus subspicatus (OECD 201, read across)

Non-Classification justification according to CLP

Fatty acids, C12 -16 (even numbered) and C18 unsatd., methyl ester (CAS No. 1234694-02-0) is considered to be rapidly degradable. Valid acute and chronic toxicity data showed to be > 1 mg/L. Fatty acids, C12 -16 (even numbered) and C18 unsatd., methyl ester does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

Non-Classification justification according to DSD

Based on the data above, Fatty acids, C12 -16 (even numbered) and C18 unsatd., methyl ester (CAS No. 1234694-02-0) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is > 1 mg/L in water for fish, algae and daphnia. Therefore, Fatty acids, C12 -16 (even numbered) and C18 unsatd., methyl ester does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.