Registration Dossier

Diss Factsheets

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 13of 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 (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 the category concept is applied to the polyol esters, data gaps will be filled by interpolation, as part of a read across approach from a representative category member(s) to avoid unnecessary animal testing. Additionally, once the category concept is applied, substances will be classified and labelled on this basis.

Degradation

Biodegradation: readily biodegradable (75% after 28 d, ISO 10708)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.

Aquatic acute toxicity

96 h, LC50 (Brachydanio rerio) > 1000 mg/L (nominal), no observed toxicological effects up to the water solubility limit (< 0.05 mg/L)

72 h, EL50 (Desmodesmus subspicatus) > 100 mg/L, (read across), no observed toxicological effects up to the water solubility limit (< 0.05 mg/L)

48 h, EL50 (Daphnia magna) > 100 mg/L (nominal), (read-across),no observed toxicological effects up to the water solubility limit (< 0.05 mg/L)

Aquatic chronic toxicity

21 d, NOELR (Daphnia magna) ≥ 1 mg/L, no observed toxicological effects up to the water solubility limit (< 0.05 mg/L)

72 h, NOEL (Desmodesmus subspicatus) ≥ 100 mg/L, (read across), no observed toxicological effects up to the water solubility limit (< 0.05 mg/L)

CLP:

Based on the data above,2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (< 0.05 mg/L) for fish, algae and aquatic invertebrates. Valid chronic data are available for daphnids and algae and did not result in toxicological effects up to the water solubility limit (< 0.05 mg/L). Therefore,2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)does not meet the criteria for classification and labelling environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (2nd ATP).

DSD:

The substance is poorly soluble in water and no effects occurred up to its solubility limit in acute tests for fish, algae and aquatic invertebrates. Therefore,2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)does not meet the criteria for classification and labelling environmental hazardous according to Directive 67/548/EEC.

Conclusion on classification