Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
121 230.36 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
12 123.036 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
24 241.812 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Derivation of PNECs is based on ECHA TGD "Guidance on information requirements and chemical safety assessment - Chapter R.10: Characterisation of dose[concentration]-response for environment.

 

PNEC aqua (freshwater)

For the component diisotridecyl adipate or alternatively for di-2-ethylhexyl adipate as supporting substance, short-term toxicity tests have been performed for three trophic levels: fish (Cyprinodon variegates), invertebrates (Daphnia magna), and green algae (Pseudokirchnerella subcapitata).

Adjusted to diisotridecyl adipate if needed, E(L)C 50 were: fish > 5000 mg/L, Daphnia > 1000 mg/L. Algae = 100 mg/L.

For the substance Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study on the long-term toxicity to aquatic organism available. In a 21 day Daphnia magna reproduction test with the analogue substance bis-(2-ethylhexyl) adipate as test substance, a NOEC of >= 0.77 mg/L was determined (highest dose tested). Toxic effects on reproduction and mortality of adult daphnids are above the water solubility of the test substance (Huels AG, 1996a). This result is confirmed by another valid study of Robillard et al., 2008. Therefore it is likely that the less water soluble substance Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is also not toxic to aquatic invertebrates in the range of its water solubility.

The L(E)C50 of 100 mg/L for algae will be used for derivation of the PNEC aqua (freshwater).

According to table R.10.4 of TGD Chapter R.10, an assessment factor of 1000 is applied to the EC50 value.

 

PNEC aqua (marine water)

As stated above, the lowest E(L)50 value for aquatic short-term toxicity will be used for derivation of PNEC. To the L(E)C50 of 100 mg/L, an assessment factor of 10,000 according to table R.10.4 of TGD Chapter R.10 is applied.

 

PNEC aqua (intermittent release)

As stated above, the lowest E(L)50 value for aquatic short-term toxicity will be used for derivation of PNEC. To the L(E)C50 of 100 mg/L, an assessment factor of 100 according to table R.10.4 of TGD Chapter R.10 is applied.

 

PNEC STP

For the derivation of PNEC STP, an activated sludge respiratory inhibition test (OECD TG 209/EU method C.11) for the component diisotridecyl adipate is available. EC50 and NOEC have been determined, both reported to be > 480 mg/L (value adjusted for diisotridecyl adipate). According to TGD Chapter R.10 section R.10.4.2 and table R.10-6, assessment factors of 100 or 10 are applied to the EC50 or NOEC values respectively. A NOEC of 480 mg/L and an assessment factor of 10 is used to derive the PNEC STP.

 

PNEC sediment f(reshwater)

According to the TGD Chapter R.10,the PNEC sediment can provisionally be calculatedin the absence of data for sediment-dwelling organisms using the equilibrium partitioning method (EPM).

PNEC derivation following procedures of TGD (Chapter R.10 and Chapter R.16):

PNEC water (freshwater): 0.1 mg/L,

Koc: 121230001 (US EPA EPI Suite estimate, program KOCWIN v2.00, IUCLID Sect. 5.4.1);

The PNEC sediment freshwater was calculated to 121230,36 mg/kg dw.

 

PNEC sediment (marine water)

According to the TGD Chapter R.10,the PNEC sediment can provisionally be calculated in the absence of data for sediment-dwelling organisms using the equilibrium partitioning method (EPM). For the marine environment, the PNEC aqua (marine water) is used.

PNEC derivation following procedures of TGD (Chapter R.10 and Chapter R.16):

PNEC water (marine water): 0.01 mg/L,

Koc: 12123000 (US EPA EPI Suite estimate, program KOCWIN v2.00, IUCLID Sect. 5.4.1) for the component diisotridecyl adipate;

The PNEC sediment (marine water) was calculated to 1213.036 mg/kg ww. This value was converted to dry weight (conversion factor of 4.6).

 

PNEC soil:

According to the TGD Chapter R.10, the PNEC soil can provisionally be calculatedin the absence of data for soil organisms using the equilibrium partitioning method (EPM).

PNEC derivation following procedures of TGD (Chapter R.10 and Chapter R.16):

PNEC water (freshwater): 0.1 mg/L,

Koc: 12123000 (US EPA EPI Suite estimate, program KOCWIN v2.00, IUCLID Sect. 5.4.1) for the component diisotridecyl adipate,

HLC: 8.89 Pa*m³/mol (EPA EPI Suite estimate, program HENRYWIN v3.20, IUCLID Sect. 5.4.2);

The PNEC soil was calculated to 24241.8115 mg/kg dw. .

 

PNEC oral

Secondary poisoning is not of concern for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol. The substance is readily biodegradable and the potential for aquatic bioaccumulation is low (calculated BCF = 14.83 for the component diisotridecyl adipate). There is no concern about toxic effects resulting from exposure via the food chain.

Conclusion on classification

Acute aquatic toxicity tests showed EC50 values > > 100 mg/l for all species. Therefore the substance is not classified.

The substance is not classfiable for the environment as it is readily biodegradable.