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 the group concept is applied to the members of the Glycerides category, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

 

Classification related key information

 

Biodegradation in water: screening tests:  79% in 28 days (read-across, OECD 301F).

 

Bioaccumulation: No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3).

 

Acute toxicity:

Fish:   

LC50 (48 h) (Danio rerio): no effects up to the limit of water solubility (read-across, ISO 7346-1).

Aquatic invertebrates:

EC50 (48 h) (Daphnia magna): no effects up to the limit of water solubility (read-across, EU C.2).

Algae:

EC50 (72 h) (Scenedesmus subspicatus): no effects up to the limit of water solubility

(read-across, EU C.3).

 

Chronic toxicity:

Aquatic invertebrates:

NOELR (21 d)(Daphnia magna): no effects up to the limit of water solubility

(read-across, OECD 211).

Algae:

NOEC (72 h) (Scenedesmus subspicatus): no effects up to the limit of water solubility

(read-across, EU C.3).

 

Non-classification justification according to CLP

Based on the data above, Glycerides, C16-18 and C18-unsatd. mono- (CAS No. 91744-09-1) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae show no effects up to the limit of water solubility. Therefore, Glycerides, C16-18 and C18-unsatd. mono- does not need to be classified and labelled as acute aquatic hazard according to the 2nd ATP of Regulation (EC) No.1272/2008 (CLP).

Valid chronic toxicity data are available, with NOEC values (aquatic invertebrates and algae) showing no effect up to the limit of water solubility. Thus Glycerides, C16-18 and C18-unsatd. mono- does not need to be classified and labelled as long-term aquatic hazard according to the 2nd ATP of Regulation (EC) No.1272/2008 (CLP).

 

Non-classification justification according to DSD

Based on the data above, Glycerides, C16-18 and C18-unsatd. mono- (CAS No. 91744-09-1) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae show no effects up to the limit of water solubility. Considering this information, Glycerides, C16-18 and C18-unsatd. mono- does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.