Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.003 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 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:
0.011 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
33.3 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 (OECD 301C)      

                                                                  

Bioaccumulation:                       

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

Acute toxicity:

-         Fish: LC50 (96 h) > 0.52 mg/L for Oryzias latipes (OECD 203)

-         Aquatic invertebrates: EC50 (48 h) = 0.255 mg/L for Daphnia magna (OECD 202)

-         Algae: EC50 (72 h) = 0.324 mg/L for Pseudokirchneriella subcapitata (OECD 201)

 

Chronic toxicity:

-         Aquatic invertebrates: NOEC (21 d) = 0.0814 mg/L for Daphnia magna (OECD 211)

-         Algae: NOEC (72 h) = 0.0396 mg/L for Pseudokirchneriella subcapitata (OECD 201)

 

 

Classification justification according to CLP

Based on the data above, the acute aquatic toxicity EC50 values are < 1 mg/L for Daphnia magna and Pseudokirchneriella subcapitata. Methyl laurate needs to be classified and labelled as acute aquatic hazard Category 1 according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

Methyl laurate is considered as rapidly degradable. Valid chronic data are available once more for Daphnia magna and Pseudokirchneriella subcapitata, for which NOEC values < 1 mg/L were reported (lowest NOEC (72 h) = 0.0396 mg/L for Pseudokirchneriella subcapitata). Thus, methyl laurate needs to be classified and labelled as long-term aquatic hazard Chronic Category 2 according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: not to be assigned

 

Classification justification according to DSD

Based on the data above, methyl laurate (CAS No. 111-82-0) is considered to be rapidly biodegradable and have low bioaccumulation potential. Nevertheless, the acute aquatic toxicity tests available resulted in EC50 values < 1 mg/L for Daphnia magna and Pseudokirchneriella subcapitata. Thus, methyl laurate needs to be classified and labelled as environmental hazard R50 according to the Directive 67/548/EEC.