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:
PNEC soil
PNEC value:
6.86 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Conclusion on Classification

Classification related key information

Log Kow: 11.55 (KOWWIN v1.68)

Water solubility: < 0.05 mg/L (EU method A.6)

Biodegradation: readily biodegradable, 72% after 28 d (OECD 301B, CO2 evolution)

Bioaccumulation: Assumed to be low based on (Q)SAR calculations, intrinsic properties and fate of the substance.

Aquatic acute toxicity

For fish: No toxic effects up to the limit of water solubility (< 0.05 mg/L) for fish (OECD 203)

For algae: No toxic effects up to the limit of water solubility (< 0.05 mg/L) for algae (OECD 201), read across

For crustacean: No data available

Aquatic chronic toxicity

For fish: No data available

For algae: No toxic effects up to the limit of water solubility (< 0.05 mg/L) for algae (OECD 201), read across

For crustacean: NOELR (21 d): 4.0 mg/L for Daphnia magna (OECD 211)

 

Non-Classification justification according to CLP

Based on the data above, Diisodecyl azelate (CAS 28472 -97-1) is considered rapidly degradable. No effects were observed up to the limit of water solubility in the acute toxicity studies. Valid chronic toxicity data are available for algae and Daphnia. No toxic effects were observed up to the limit of water solubility (< 0.05 mg/L in aqua dest) for algae (OECD 201) based on read across. The NOELR value for Daphnia is determined at 4 mg/L. Therefore, Diisodecyl azelate (CAS 28472 -97-1) does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No 1272/2008 (CLP) and the Regulation (EU) No 2015/1221 (7th ATP).

Non-Classification justification according to DSD

Based on the data above, Diisodecyl azelate (CAS 28472 -97-1) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is > 100 mg/L and the solubility of the substance in water for fish, algae and daphnia. Therefore, Diisodecyl azelate (CAS 28472 -97-1) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.