Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.135 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.013 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.033 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.293 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

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 read-across data are used for isodecyl pivalate, data will be generated from a representative analogue substance 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: 35.4% after 28 d (OECD 301B)

 

Bioaccumulation

(Q)SAR: Bioaccumulation is assumed to be low (BCF: 202 - 241.5 L/kg)

 

Aquatic acute toxicity

96 h, LL50 (Danio rerio): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit based on mortality); read-across

 

Aquatic chronic toxicity

21 d, NOELR (Daphnia magna): < 13.34 µg/L (TWM)

 

CLP

Based on the data above, isodecyl pivalate is (CAS 60209-82-7) is not considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (< 0.05 mg/L) for fish. A valid chronic study with Daphnia magna resulted in a NOELR (21 d) < 13.34 µg/L (TWM). Therefore, isodecyl pivalate has to be classified and labelled as environmental hazard Chronic Cat. 1 (H410) according to the consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments.

M-factor for chronic aquatic toxicity: 10

 

DSD

The substance is poorly soluble in water and no effects occurred up to its solubility limit in an acute test for fish. Therefore, isodecyl pivalate does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.