Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.02 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:
0.1 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

All studies investigating the aquatic toxicity were performed with

aspartic acid, N,N'-[methylenebis(2-methyl-4,1-cyclohexanediyl)]bis-, 1,1',4,4'-tetraethyl ester which is a structural analogue to aspartic acid, N,N'-(methylenedi-4,1-cyclohexanediyl)bis-, 1,1',4,4'-tetraethyl ester.Both substances are diethyl esters of aspartic acid linked to a dicyclohexylmethyldiamine moiety. The difference between these two substances is merely the presence of two methyl groups connected to the cyclohexane rings. This structural analogy was confirmed by the Member State responsible for the notification of both substances under the NONS regulation. The Member State decided that test results obtained for one substance can be transferred to the other substance and that testing of both substances is usually not required. This decision is in accordance with the grouping of substances and read-across approach in Annex XI, 1.5 of the REACH Regulation.

Conclusion on classification

Studies were performed with aspartic acid, N,N’-[methylenebis(2-methyl-4,1-cyclohexanediyl) ]bis-, 1,1',4,4'-tetraethyl ester which is a structural analogue to aspartic acid, N,N’-(methylenedi-4,1-cyclohexanediyl) bis-, 1,1',4,4'-tetraethyl ester. Both substances are diethyl esters of aspartic acid linked to a dicyclohexylmethyldiamine moiety. The difference between these two substances is merely the presence of two methyl groups connected to the cyclohexane rings. This structural analogy was confirmed by the responsible for the notification of both substances under the NONS regulation. The Member State decided that test results obtained for one substance can be transferred to the other substance and that testing of both substances is usually not required. This decision is in accordance with the grouping of substances and read-across approach in Annex XI, 1.5 of the REACH Regulation.

Aspartic acid, N,N’-(methylenedi-4,1-cyclohexanediyl) bis-, 1,1',4,4'-tetraethyl ester has no acute effects towards aquatic organisms up to the limit of the water solubility as observed when testing the structural analogueaspartic acid, N,N’-[methylenebis(2-methyl-4,1-cyclohexanediyl) ]bis-, 1,1',4,4'-tetraethyl ester. The most sensitive chronic toxicity of Aspartic acid, N,N'-[methylenebis(2-methyl-4,1-cyclohexanediyl)]bis-, 1,1',4,4'-tetraethyl ester was determined in a long-term study with daphnia: NOEC (21d)= 0.013 mg/L.

Aspartic acid, N,N’-(methylenedi-4,1-cyclohexanediyl) bis-, 1,1',4,4'-tetraethyl ester is neither readily biodegradable as observed when testing the structural analogueaspartic acid, N,N’-[methylenebis(2-methyl-4,1-cyclohexanediyl) ]bis-, 1,1',4,4'-tetraethyl ester, nor is it inherently biodegradable. But based on results from the same structural analogue, hydrolyzing with a half life of 25 h at a temperature of 25 °C and at pH 7, a similar degradation behaviour of aspartic acid, N,N’-(methylenedi-4,1 -cyclohexanediyl)bis-, 1,1',4,4'-tetraethyl ester can be assumed.

Aspartic acid, N,N’-(methylenedi-4,1-cyclohexanediyl) bis-, 1,1',4,4'-tetraethyl ester has no potential to bioaccumulate.

In the regulation (EC) No 1272/2008 the substance has been legally classified as “aquatic chronic 3” (H412). According to the present data listed above and in accordance with the 2nd ATP of the CLP regulation (EC) 1272/2008 (286/2011), a stricter classification for the aquatic compartment has been proposed as “aquatic chronic 1”  (H410). The appropriate multiplying factor for chronic toxicity is 1. Concerning acute aquatic toxicity, the substance should not be classified, due to the lack of acute aquatic toxicity.

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