Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 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)                                                          

Bioaccumulation:                       

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

 

Acute toxicity:

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

-         Aquatic invertebrates: EC50 (48 h) = 5.6 mg/L (QSAR)

-         Algae: LC50 (96 h) = 4.76 mg/L for green algae (QSAR)

 

Chronic toxicity:

-         Fish: not available

-         Aquatic invertebrates: NOEC (21 d) = 1.8 mg/L (OECD 211)

-         Algae: not available

 

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 octanoate 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 toxicity data are available for aquatic invertebrates, with a NOECs > 1 mg/L. Therefore, Methyl octanoate does not need to be classified and labelled as long-term aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

 

Classification justification according to DSD

Based on the data above, methyl octanoate (CAS No. 111-11-5) 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 octanoate does not need to be classified and labelled according to Directive 67/548/EEC.