Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 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:
1.91 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2.93 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.293 mg/kg sediment dw
Assessment factor:
1 000
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:
2.38 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The following table shows the results of the acute ecotox tests:

Results of acute ecotoxicological tests:

 

Highest concentration tested with no effect in mg/L (EC/LC0)

EC/LC50
[mg/L]

Remarks

fish

8.1

>8.1

 

invertebrates

8.3

>8.3

 

algae

5

>5

72 h-ErC50

Since there are acute test results available for 4,4’-methylenedicyclohexyl diisocyanate (which include the hydrolysis product) from three trophic levels, an assessment factor of 1000 would be applicablefor the derivation of the PNECaqua according to the REACH Guidance Document (ECHA 2008). The reported NOEC value is indeed statistically significant, but not from a biological point of view. T

Conclusion on classification

The substance is rapidly degradable (hydrolysis). The hydrolysis product is - beside insoluble oligomeric and polymeric ureas - the corresponding 4,4´-Methylenedicyclohexyl diamine. As the half life of the parent substance was determined to be 2 h and as the test solutions were stirred for 24 h it can be assumed that only the hydrolysis products were present in the test solutions and thus potential effects were caused by the hydrolysis products rather than by the parent substance. 

Classification according to Regulation 1272/2008

The substance is not to be classified acutely hazardous to the aquatic environment, since no acute effects are reported. Chronic data are given for algae, however they are considered to be not relevant. Furthermore the substance degrades rapidly with a half-life of about 2 hours, no classification is required based on chronic toxicity data.

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