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 "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 substance. This avoids the need to test every substance for every endpoint”.

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

 

Brief description of the data relevant for classification

Degradation

Biodegradation: not readily biodegradable: 20.7-45% of CO2 evolution (EU method C.4-C)

 

Bioaccumulation

Expert statement: Bioaccumulation is expected to be low (see section 5.3.1 for details)..

 

Aquatic acute toxicity

For fish: 96 h, LC50 (Brachydanio rerio): no effects up to the limit of water solubility (> 4.1 mg/L (measured, WAF))

For aquatic invertebrates: 48 h, EC50 (Daphnia magna): no effects up to the limit of water solubility (> 3.2 mg/L (measured, WAF))

For algae/aquatic plants: 72 h, ErC50 (Scenedesmus subspicatus): no effects up to the limit of water solubility (> 3.5 mg/L (measured, WAF))

 

Aquatic chronic toxicity

For aquatic invertebrates: 21 d, NOEC (Daphnia magna): no effects up to the limit of water solubility (≥ 4.5 mg/L (measured, WAF))

For algae/aquatic plant: 72 h, NOEC (Scenedesmus subspicatus): no effects up to the limit of water solubility (≥ 3.5 mg/L (measured, WAF)

 

CLP:

Based on the data above, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS No. 94279-36-4) is considered to be not rapidly biodegradable but shows low bioaccumulation potential. The substance is poorly soluble in water (< 0.05 mg/L), and no effects occurred up to its water solubility limit in acute tests with fish, algae and daphnia. Valid chronic toxicity data are available for aquatic invertebrates and algae (L(E)C50 values > 1 mg/L). No chronic effects were observed up to the limit of water solubility (NOEC values > 1 mg/L). Therefore, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP).

 

DSD:

The substance is poorly soluble in water (< 0.05 mg/L), not rapidly biodegradable and no effects occurred up to its solubility limit in acute and chronic tests with fish, daphnia and algae (EC50 and NOEC values > 1 mg/L). Therefore, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.