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

Classification related key information

Log Kow: >10 (KOWWIN v1.68)

Water solubility: < 1 mg/L (WoE)

Biodegradation: 75% in 28 days (OECD 301F)

BCF: <1 L/kg (BCFBAF v3.01; Arnot-Gobas estimate) 

Aquatic acute toxicity:

For fish: LC50 (96h) no toxic effects up to the limit of water solubility (< 1 mg/L) for fish (OECD 203), read across

For algae: EC50 (72h) no toxic effects up to the limit of water solubility (< 1 mg/L) for algae (OECD 201), read across

For crustacea: EC50 (48h) no toxic effects up to the limit of water solubility (< 1 mg/L) for D. magna (OECD 202)

Aquatic chronic toxicity:

For fish: no data

For algae: NOEC (72h) no toxic effects up to the limit of water solubility (< 1 mg/L) for algae (OECD 201), read across

For crustacea: NOErC (21d) no toxic effects up to the limit of water solubility (< 1 mg/L) for D. magna (OECD 211), read across

Non-Classification justification according to CLP

Based on the data above, the acute aquatic toxicity L(E)C50 is above the limit of water solubility for fish, algae and aquatic invertebrates. Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) does not need to be classified and labeled as acute aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) is considered to be rapidly degradable. Valid chronic toxicity data are available to invertebrates and algae – the NOEC is above the limit of water solubility for both. Therefore Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) does not need to be classified and labeled as long-term aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

M-factor for chronic aquatic toxicity: -

Non-Classification justification according to DSD

Based on the data above, Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is above the limit of water solubility in water for fish, algae and daphnia. Therefore, Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.