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:
insufficient hazard data available (further information necessary)

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”. Additionally, once the analogue concept is applied, substances will be classified and labelled on this basis.

 

Biodegradation: not readily biodegradable (4.3% after 60 d, OECD 301B)

Bioaccumulation: Expert statement - Bioaccumulation is assumed to be low.

 

Aquatic acute toxicity

96 h, LL50 (Oncorhynchus mykiss) > 1000 mg/L (nominal), no observed toxicological effects up to the water solubility limit, read across

48 h, EL50 (Daphnia magna) > 100 mg/L (nominal), (read across), no observed toxicological effects up to the water solubility limit, read across

72 h, EL50 (Scenedesmus subspicatus) > 100 mg/L, (read across), no observed toxicological effects up to the water solubility limit, read across

 

Aquatic chronic toxicity

72 h, NOELR (Scenedesmus subspicatus) ≥ 100 mg/L, (read across), no observed toxicological effects up to the water solubility limit, read across

21 d, NOELR (study ongoing)

 

CLP 

3,5,5 trimethylhexanoic acid, mixed esters with dipentaerythritol (CAS 84418-63-3) is not readily biodegradable and has a low potential to bioaccumulate. The substance is not considered to be acutely toxic to fish, aquatic invertebrates or algae since no toxic effects were observed up to the limit of water solubility. Data on chronic toxicity indicate no toxicological effects up to the limit of water solubility as well. Therefore, 3,5,5 trimethylhexanoic acid, mixed esters with dipentaerythritol (CAS 84418-63-3) does not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (5th ATP).

 

DSD 

3,5,5 trimethylhexanoic acid, mixed esters with dipentaerythritol (CAS 84418-63-3) is not readily biodegradable and has a low potential to bioaccumulate. The substance is poorly soluble in water and no effects occurred up to the water solubility limit in acute tests for fish, algae and aquatic invertebrates. Therefore, 3,5,5 trimethylhexanoic acid, mixed esters with dipentaerythritol (CAS 84418-63-3) does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.