Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.032 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.016 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 000 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

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:
1 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: 4.17 (INCHEM Database)

Water solubility: 35 mg/L (INCHEM Database)

Biodegradation: 90 % in 14 days (OECD 301C)

BCF: 12.55 L/kg (BCFBAF v3.01; Arnot-Gobas estimate) 

Aquatic acute toxicity:

For fish: LC50 (96h) = 3.64 mg/L (measured) for P. promelas (OECD 203)

For algae: EC50 (72h) = 5.16 mg/L (nominal) for P. subcapitata (OECD 201)

For crustacea: EC50 (48h) = 1.614 mg/L (nominal) for D. magna (ECOSAR v1.00)

Aquatic chronic toxicity:

For fish: no data

For algae: NOEC (72h) = 3 mg/L (nominal) for P. subcapitata (OECD 201)

For crustacea: NOEC (21d) = 1.5 mg/L (measured) for D. magna (OEVD 211)

Non-Classification justification according to CLP

Based on the data above, The acute aquatic toxicity L(E)C50 is > 1 mg/L for fish, algae and aquatic invertebrates. Dibutyl adipate (CAS 105-99-7) does not need to be classified and labelled as acute aquatic hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP).

Dibutyl adipate (CAS 105-99-7) is considered to be rapidly degradable. Valid chronic toxicity data are available to algae and aquatic invertebrates – the lowest NOEC is 1.5 mg/L. Dibutyl adipate (CAS No. 105-99-7) does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

M-factor for chronic aquatic toxicity: -

Non-Classification justification according to DSD

Based on the data above, Dibutyl adipate (CAS 105-99-7) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is > 1 mg/L in water for fish, algae and daphnia. Therefore, Dibutyl adipate (CAS 105-99-7) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.