Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

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: not readily biodegradable according to OECD criteria

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic toxicity

Short-term toxicity to fish (Read-across data):

LL50 (96 h)>100 mg(L

Short-term toxicity to aquatic invertebrates (Read-across data):

EL50 (48 h)> 100mg/L

Long-term toxicity to aquatic invertebrates (Read-across data):

NOELR (21 d) ≥1mg/L

Toxicity to aquatic algae and cyanobacteria (Read-across data):

EL50 (72h) > 100 mg/L

NOELR (72 h) ≥ 100 mg/L

Toxicity to microorganisms (derived from OECD 301 B):

NOEC (14 d) ≥ 23.2 mg/L

CLP

Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is not readily biodegradable. The substance is considered not acutely or chronically toxic to aquatic organisms. Thus,Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty aciddoes not need to be classified and labelled as environmental hazardous according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).