Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.315 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 read-across was applied for the substance, data will be generated from representative source substances to avoid unnecessary animal testing. Additionally, once the read-across approach is applied, substances will be classified and labelled on this basis.

Degradation

Biodegradation: readily biodegradable: 81% after 28 d (OECD 301F, O2 consumption)

Bioaccumulation

Weight of evidence: Bioaccumulation is assumed to be low.

 

Aquatic acute toxicity

Fish
96 h, LL50 (Danio rerio): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic invertebrates
No data available

 

Aquatic algae
72 h, ErL50 (Pseudokirchneriella subcapitata): > 100 mg/L, ErL10: > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

 

Aquatic chronic toxicity
Fish: No data available
Aquatic invertebrates: 21 d, NOELR (Daphnia magna): 60 mg/L (nominal)
Aquatic algae: 72 h, ErC10 (Pseudokirchneriella subcapitata): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

CLP

Based on the data above, Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) is considered to be readily degradable. No acute aquatic toxicity was observed for fish and algae. Valid chronic data are available with an ErC10 (72 h) > 100 mg/L for the algae Pseudokirchneriella subcapitata and a NOELR (21 d) of 60 mg/L for Daphnia magna. Therefore, Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates does not need to be classified and labelled as environmental hazard according to the 6th ATP of the Regulation (EC) No 1272/2008 (CLP).