Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.011 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.11 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
10 000
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:
0.079 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.008 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:
no potential for bioaccumulation

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)    

                                                                  

Bioaccumulation:                       

Log Pow = 2.34

 

Acute toxicity:

-         Fish: LC50 (48 h) 170 mg/L for Leuciscus idus (DIN 38412/15)

LC50 (48 h) > 100 < 300 for Leuciscus idus (read-across) (DIN 38412/15)

LC50 (96 h) > 0.52 mg/L (measured) for Oryzias latipes (read-across) (OECD 203)

LC50 (48 h) = 1700 mg/L for Leuciscus idus (read-across) (DIN 38412/15)

-         Aquatic invertebrates: EC50 (48 h) = 40 mg/L (loading rate) and 28 mg/L (mean measured concentration)(OECD 202)

-         Algae: EC50 (72 h) = 61 mg/L (growth rate, loading rate) and 11 mg/L (mean measured concentration)(OECD 201)

EC50 (96 h) = 16.2 mg/L for green algae (QSAR)

Chronic toxicity:

- Algae: NOEC (72 h) = 12.5 mg/L (growth rate, loading rate) and 2.7 mg/L (mean measured concentration)(OECD 201)

-   Aquatic invertebrates: Testing according to OECD 211 (Daphnia sp. Reproduction test) is currently ongoing (on a suitable read-across substance, methyl octanoate (CAS No. 111-11-5). The dossier will be updated as soon as possible and the need for classification will be re-evaluated based on the outcome of this new study.

 

 

Classification justification according to CLP

Based on the data above, the acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Methyl hexanoate (CAS No. 106-70-7) does not need to be classified and labeled as acute aquatic hazard according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

Valid chronic data are available for algae, for which a NOEC value > 1 mg/L was reported. Since methyl hexanoate is considered to be rapidly degradable and to have low bioaccumulation potential, the substance does not need to be classified and labelled as long-term aquatic hazard according tothe 2nd ATP of Regulation (EC) No. 1272/2008 (CLP). Nevertheless, testing according to OECD 211 (Daphnia sp. Reproduction test) is currently ongoing (on a suitable read-across substance). The dossier will be updated as soon as possible and the need for classification will be re-evaluated based on the outcome of this new study.

 

Classification justification according to DSD

Based on the data above, methyl hexanoate (CAS No. 106-70-7) is considered to be rapidly biodegradable and to have low bioaccumulation potential. The acute aquatic toxicity tests available resulted in L(E)C50 values > 1 mg/L for fish, aquatic invertebrates and algae. Thus, methyl hexanoate does not need to be classified and labeled according to Directive 67/548/EEC.

Nevertheless, testing according to OECD 211 (Daphnia sp. Reproduction test) is currently ongoing (on a suitable read-across substance). The dossier will be updated as soon as possible and the need for classification will be re-evaluated based on the outcome of this new study.