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

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.

Degradation

Biodegradation: degradation of >60% within 28 days (read-across from similar substances)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic acute toxicity

Fish: 96 h, LL50 (Cyprinus carpio): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

96 h, LL50 (Danio rerio): > 10,000 mg/L (nominal based on WAF; no observed toxicological effects up to the water solubility limit); read-across  

Aquatic invertebrates: 48 h, EC50 (Daphnia magna): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

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

Aquatic algae: 72 h,ErL50(Desmodesmus subspicatus): > 100 mg/L (nominal based on WAF; no observed toxicological effects up to the water solubility limit); read-across

 

Aquatic chronic toxicity

Fish: no data available

Aquatic invertebrates: 21 d, NOELR (Daphnia magna):135 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic algae: 72 h, EL50 (Desmodesmus subspicatus):100 mg/L (WAF, for the algal growth rate and algal cell growth.); read-across

CLP

Based on the data above, Pentaerythritol, mixed esters with linear and branched fatty acids is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (< 0.01 mg/L at 20°C) for fish, algae and daphnids. Valid chronic data are available with a EL50 (72 h)100 mg/L for the algae Desmodesmus subspicatus and a NOELR (21 d)135 mg/L for Daphnia magna. Therefore, Pentaerythritol, mixed esters with linear and branched fatty acidsdoes not need to be classified and labelled as environmental hazard according to the 6th ATP of the Regulation (EC) No 1272/2008 (CLP).