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

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.

Conclusion on classification

Degradation

Biodegradation: readily biodegradable: 91% (CO2 evolution) after 28 d (OECD 301B), read across

Bioaccumulation

The substance is likely to show negligible bioaccumulation potential based on the information gathered on the metabolism of aliphatic esters by the fish in combination with QSAR-estimated values (BCF/BAF: 152.9 / 703.9 L/kg).

Aquatic acute toxicity

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

Aquatic chronic toxicity

21 d, NOELR (Daphnia magna): ≥ 100 mg/L (nominal; OECD 211; no observed toxicological effects up to the water solubility limit based on reproduction), read across

CLP

Based on the data above, 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) is considered to be rapidly degradable and not bioaccumulable. No acute aquatic toxicity was observed up to the water solubility limit ( 1.5-4.4 µg/L at 20 °C) for fish (read across). Valid chronic data are available with a NOELR (21 d) ≥ 100 mg/L (i.e. up the limit of water solubility) for Daphnia magna (read across). Therefore, 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) does not need to be classified and labelled for environmental hazard according to the Regulation (EC) No. 1272/2008 (CLP).