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 exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Degradation

Biodegradation: readily biodegradable: 86% (O2 consumption) of isononanoic acid, C16-18 alkyl esters after 30 d (OECD 301D)

 

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

 

Aquatic acute toxicity

96 h, LC50 (Brachydanio rerio): > 10000 mg/L (nominal; No observed toxicological effects up to the water solubility limit)

48 h, EC50 (aquatic invertebrates): no data

72 h, ErL50 (Desmodesmus subspicatus): > 100 mg/L (nominal; No observed toxicological effects up to the water solubility limit based on growth rate)

 

Aquatic chronic toxicity

fish: no data

21 d, NOELR (Daphnia magna): ≥ 10 mg/L (nominal; No observed toxicological effects on reproduction up to the water solubility limit)

72 h, NOELR (Desmodesmus subspicatus): ≥ 100 mg/L (nominal; No observed toxicological effects up to the water solubility limit based on growth rate)

 

CLP

Based on the data above, isononanoic acid, C16-18 alkyl esters is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (< 0.05 mg/L) for fish and algae. Valid chronic data are available with a NOELR (72 h) ≥ 100 mg/L (i.e. above the limit of water solubility) for Desmodesmus subspicatus and no effects on reproduction of Daphnia magna up to the water solubility limit (OECD 211). Therefore, isononanoic acid, C16-18 alkyl esters does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

 

DSD

The substance is poorly soluble in water and no effects occurred up to its solubility limit in acute tests for fish and algae. Therefore, isononanoic acid, C16-18 alkyl esters does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.