Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.67 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Classification related key information

Water solubility: < 0.02 mg/L (OECD 105)

Biodegradation in water: screening tests: 4% (CO2 evolution) after 29 days (OECD 301B)

Log Pow: 8.4

 

Acute aquatic toxicity

- to fish: No effects were observed in the range of the water solubility of the test substance (< 0.02 mg/L), LC50 (96 h) > 0.014 mg/L, Cyprinus carpio (OECD 203, EU Method C.1)

- to aquatic invertebrates: No effects were observed in the range of the water solubility of the test substance (< 0.02 mg/L), EC50 (48 h) > 0.017 mg/L, Daphnia magna (OECD 202, EU Method C.2)

- to algae: No effects were observed in the range of the water solubility of the test substance (< 0.02 mg/L), Pseudokirchneriella subcapitata (OECD 201, EU Method C.3)

 

Chronic aquatic toxicity:

- to fish: not available

- to aquatic invertebrates: not available

- to algae: No effects were observed in the range of the water solubility of the test substance (< 0.02 mg/L), Pseudokirchneriella subcapitata (OECD 201, EU Method C.3).

 

Classification justification according to CLP

2 -Hexyl-2 '-hydroxy-5 'methyldecananilide (AF-654) is poorly soluble in water and no toxicity to aquatic organisms (fish, aquatic invertebrates, algae) was observed up to its water solubility limit (< 0.02 mg/L). Nevertheless, since the substance is not rapidly biodegradable and exhibits a potential for bioaccumulation (log Pow 8.4), AF-654 is classified as environmental hazard Chronic Cat. 4 according to the regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

 

Classification justification according to DSD

For fish, aquatic invertebrates and algae, no toxic effects were observed up to the water solubility limit of 2 -Hexyl-2 '-hydroxy-5 'methyldecananilide (AF-654) (<0.02 mg/L).

Based on the data above, the substance is considered to have a potential for bioaccumulation and is not rapidly degradable. Therefore, AF-654 is classified as environmental hazard R53 according to the Directive 67/548/EEC (DSD).