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 exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

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 category members of the PFAE fumarates, 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.

Conclusion on classification

Classification related key information

Log Kow: >10 (KOWWIN v1.68)

Water solubility: > 0.01 mg/L and < 0.05 mg/L at 20 °C, pH=5.6-5.7 (OECD 105, column elution method)

Biodegradation: Readily biodegradable: 60-70% based on CO2 evolution and oxygen consumption, read across

BCF: <1 L/kg (BCFBAF v3.01; Arnot-Gobas estimate)

Aquatic acute toxicity:

For fish: LC50 (96h) no toxic effects up to the limit of water solubility (< 0.05 mg/L in aqua dest) for D. rerio (OECD 203), read across

For aquatic invertebrates: EC50 (48h) no toxic effects up to the limit of water solubility (< 0.05 mg/L in aqua dest) for D. magna (OECD 202), read across

For algae: EC50 (72h) no toxic effects up to the limit of water solubility (< 0.05 mg/L in aqua dest) for D. subspicatus (OECD 201), read across

Aquatic chronic toxicity:

For fish: no data

For aquatic invertebrates: no data

For algae: NOEC (72h) no toxic effects up to the limit of water solubility (< 0.05 mg/L in aqua dest) for D. subspicatus (OECD 201), read across

 

Non-Classification justification according to CLP

Based on the data above, there is no acute aquatic toxicity up to the limit of water solubility for fish, aquatic invertebrates and algae. 2-Butenedioic acid (2E)-, di-C12-14-alkyl esters (List No 938-575-3) does not need to be classified and labeled as acute aquatic hazard according to the 4th ATP of the Regulation (EC) No.1272/2008 (CLP).

From the short-term results and taking into account that 2-Butenedioic acid (2E)-, di-C12-14-alkyl esters (List No 938-575-3) is neither persistent nor bioaccumulative also chronic toxicity is excluded. Therefore, 2-Butenedioic acid (2E)-, di-C12-14-alkyl esters (List No 938-575-3) does not need to be classified and labeled as long-term aquatic hazard according to the 4th ATP of the Regulation (EC) No.1272/2008 (CLP).

 

Non-Classification justification according to DSD

Based on the data above, 2-Butenedioic acid (2E)-, di-C12-14-alkyl esters (List No 938-575-3) is rapidly degradable and is considered to have a low potential for accumulation. There is no acute aquatic toxicity up to the limit of water solubility in water for fish, aquatic invertebrates and algae. Therefore, 2-Butenedioic acid (2E)-, di-C12-14-alkyl esters (List No 938-575-3) does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.