Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.004 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.056 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:
4.11 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
26.98 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.698 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:
no hazard identified

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 Glycerides 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: 79.5% biodegradation in 28 days (OECD 301B).  

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

Acute toxicity:

-         Fish: LL50 (96 h) > 20 mg/L (loading rate) and > 2.7 mg/L (measured concentration) for Danio rerio (OECD 203)

-         Aquatic invertebrates: EL50 (48 h) = 36.2 mg/L (loading rate) and 5.6 mg/L (measured concentration) for Daphnia magna (OECD 202)

-         Algae: ErL50 (72 h) = 13 mg/L (loading rate) for Desmodesmus subspicatus (OECD 201)

Chronic toxicity: 

-         Algae: NOErLR (72 h) = 4.1 mg/L (loading rate) for Desmodesmus subspicatus (OECD 201)

 

Classification justification according to CLP

Based on the data above, Glycerides, C12-18 di- and tri- (CAS No. 91744-28-4) is considered to be rapidly biodegradable. The acute aquatic toxicity L(E)L50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Therefore, Glycerides, C12-18 di- and tri- does not need to be classified and labeled as acute aquatic hazard according to the 2nd ATP ofRegulation (EC) No. 1272/2008 (CLP).

 

Valid chronic toxicity data are available for algae, resulting in a NOELR value > 1 mg/L. Thus, Glycerides, C12-18 di- and tri- does not need to be classified and labeled as long-term aquatic hazard according to the 2nd ATP ofRegulation (EC) No. 1272/2008 (CLP).

  

Classification justification according to DSD

Based on the data above, Glycerides, C12-18 di- and tri- (CAS No. 91744-28-4) is considered to be rapidly biodegradable and have low bioaccumulation potential. The acute aquatic toxicity tests available resulted in L(E)L50 values > 1 mg/L for fish, aquatic invertebrates and algae. Thus, the substance does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.