Dibutyl sebacate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

no hazard identified

Marine water

Hazard assessment conclusion:

no hazard identified

STP

Hazard assessment conclusion:

no data: aquatic toxicity unlikely

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:

PNEC soil

PNEC value:

0.865 mg/kg soil dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

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 linear, 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: 6.3 (EU method A.8)

Water solubility: < 0.05 mg/L (EU method A.6)

Biodegradation: 89.6% in 28 days (OECD 301B)

BCF: 281 L/kg (regression based estimate); 28.7 L/kg (Arnot-Gobas estimate) (BCFBAF v3.01)

Aquatic acute toxicity:

For fish: LC50 (96h) no toxic effects up to the limit of water solubility (< 0.05 mg/L) for fish (OECD 203)

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

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

Aquatic chronic toxicity:

For fish: no data

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

For crustacean: no data

Non-Classification justification according to CLP

Based on the data above, Dibutyl sebacate (CAS 109 -43 -3) is considered rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 100 mg/L and above the solubility of the substance in water for fish, algae and daphnia. Valid chronic toxicity data are available for algae showing no effects in the range of water solubility. Therefore, Dibutyl sebacate (CAS 109-43-3) does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Non-Classification justification according to DSD

Based on the data above, Dibutyl sebacate (CAS 109-43-3) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 are > 100 mg/L and above the solubility of the substance in water for fish, algae and daphnia. Therefore, Dibutyl sebacate (CAS 109-43-3) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.