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 analogue concept is applied to the target substance, data will be generated from representative read-across substances to avoid unnecessary animal testing. Additionally, once the analogue concept is applied, substances will be classified and labelled on this basis.

Degradation

Biodegradation: not readily biodegradable (51.5% after 28 d, OECD 301B)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.

Aquatic acute toxicity

No observed toxicological effects up to the limit of water solubility

Fish: Danio rerio LC50 (96 h): > 50 mg/L (OECD 203), read across

Aqu. invertebrates: Daphnia magna EC0 (48 h): >10000 mg/L (DIN 38412/11), read across

Algae: Pseudokirchneriella subcapitata EL50 (72 h): > 100 % (growth rate; OECD 201)

Aquatic chronic toxicity
Aqu. invertebrates: Daphnia magna NOEC (21 d): >= 10 mg/L (OECD 211), read across

CLP

1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is not readily biodegradable. The bioaccumulation potential of the substance is considered to be low. Acute aquatic toxicity L(E)C50 values are > 100 mg/L or above the limit of water solubility of the test substance. The chronic NOEC value available for Daphnia is > 1 mg/L. Therefore 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) does not meet the criteria for classification and labelling as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (2nd ATP).

DSD

1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is poorly soluble in water and acute or chronic effects were not observed up to the limit of water solubility. Therefore Fatty acids, 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) does not meet the criteria for classification and labelling as environmental hazardous according to Directive 67/548/EEC.