S ummary of Physical and C hemical P roperties of AAA R eaction P roduct

1. Vapor pressure : The AAA reaction product is composed of many different substances with different vapour pressures. Table 1 shows the vapour pressure of the major constituents in the AAA reaction product. The table also shows a theoretical calculated partial vapour pressure of each major constituent. From this table it is obvious that primarily water contributes to the overall vapour pressure of the AAA reaction product (>99%). Therefore, measurement of the vapour pressure of the AAA

- reaction product is not considered relevant for any purpose, as it mainly will reflect the concentration of water in the AAA reaction product and not the vapour pressure of any of the constituents.
Another important aspect about this substance is the fact that the substance is only used as a binder and that it does no longer exist in the final products (i.e. fibres). The binder in the final products has a negligible vapour pressure.
It is concluded that the measurement of the vapour pressure of the AAA

- reaction product is not considered to be providing technically useful new information and thus scientifically not justified.2. Solubility: No available data for the solubility of the substance in other media but water is found. Low solubility in hydrophobic solvents is expected.

3. Solubility in water: The AAA reaction product is composed of many different substances with different levels of water solubility. Table 2 shows the water solubility of major constituents in the AAA reaction product. For a measurement of the water solubility of AAA reaction product, the polymer with the lowest water solubility will determine the overall water solubility of the AAA reaction p roduct. The monomers and main impurities are all very soluble in water, but not the final binder. Further, AAA reaction product has low water solubility based on practical experience.
It is concluded that the measurement of the water solubility of the AAA

- reaction product is not considered relevant. A measured water solubility of the AAA reaction product will be determined by the water solubility of the polymer and cannot be used to assess the behaviour of the AAA reaction product in case of contact with w ater. The monomers, main impurities and small mers will be readily dissolved in water, whereas the final binder will not.

Table 2 : Water solubility of the various constituents in the AAA

- reaction product

Substance CAS

- RN Water solubility (mg/L) Reference to water solubility data

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4 . Dissociation Constant: pKa > 15 (roughly estimated from the measured pH of 6.5 of the mixture).

5 . Particle size distribution: Not relevant, as the substance is a liquid

.4 of 8 6 . Hennry’s law constant: The AAA reaction product is composed of many different substances with different levels of molecular weight, vapour pressure and water solubility. The Henrys constant of the various constituents in the AAA

- product

was calculated on the basis of their vapour pressure, water solubility and molecular weight. It was found that the Henrys constant for all substances are well below 0.02 Pa·m 3 /mole, which must be considered a very low Henrys constant.

7 . Volatilisation from water The substance does not tend to evaporate from water. EpiSuite predicts a volatilisation half

- life from 1m deep river between 0.4 year and much more than 100 years.

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. Volatilisation from soil The substances of the AAA product tend to partition to the soil pore water due to their low octanol/water partition coefficient (will not adsorp to the soil matrix) and low Henrys constant (will not be in the pore air). Due to this and the low Henrys constant, the volatilisation half

- life from soil is expected to be very low with an order of magnitude of years up to more than 100 year.

9

. pH @ concentration ≈6.5 (see M SDS attached to the PMN )

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. Flammability Flash point>120 ° C (test temperature was between 18 ° C and 120 ° C, and no flash point was tested in th e temperature range).

I t is evaluated that the Alkanolamine

- acid

- anhydride reaction product is not flammable due to its high water content and flash point. Further, it is evaluated that no flammable gas will evolve in contact with water. Based upon the structure, it is evaluated that the Alkanolamine

- acid

- anhydride reaction product does not have pyrophoric properties (Bretherick`s Handbook of Reactive Chemical Hazards).

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. Explodability T he Alkanolamine

- acid

- anhydride reaction product is a water solution/suspension

, and no dust initiated explosion will occur

. The single molecules of the Alkanolamine

- acid

- anhydride reaction product does not contain reactive groups that have explosive characteristics (Bretherick`s Handbook of Reactive Chemical Hazards).1 2. P artitioning coefficient Log Kow

No test has been initiated as it was not scientifically justified; instead a rationale for the waiving has been provided below.
The AAA reaction product is composed of many different substances. Table 3 shows the LogK ow of the major constituents in the AAA reaction product. To illustrate the properties of the polymer, estimated values for the hexamers and 20

- mers are shown. The monomers, dimers and trimers all have a low LogK ow and thus a low potential for bioaccumulation is expected.
The final products contain only the binder. The LogK ow is not relevant for the binder, as the binder is not bioavailable due to the molecular size. Even though, the binder has an estimated LogK ow of up to about 2.7, it will still not have any potential for bioaccumulation.
An experimental determination of the logK OW using the OECD 117 would be very difficult. Further, this method can only be used for the logK OW range of 0

- 6, but several of the ingredients in the AAA reaction product have a logK OW below 0. Assignment of the various peaks to specific ingredients would further be very challenging, if possible at all, as detection of the various ingredients in the AAA reaction product requires at least two chemical analyses and as several of the ingredients are foreseen to have peaks in the same range.
The monomers, dimers and trimers all have a low LogK ow and thus a very low potential for bioaccumulation and low tendency to adsorb to soil and sediments. The determination of these ingredients is assessed to be properly determined by th e current data (measurement and estimation). The final substances in the products have logK ow of about 2.7. However the polymers are not bioavailable due to their size, and will therefore not have any potential for bioaccumulation.

In conclusion it is not scientifically justified, and it is not technically feasible to perform a test.

Table 3 : LogK ow of the various constituents in the AAA

- reaction product

**Substance CAS** 

**- RN**  **logKow Reference to water solubility data** 

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. Ready Biodegradation

Test substance: AAA reaction product

Results : Not ready biodegradable

. Partly biodegradability (53%) was found after 28

- days

, but final pass level for ready biodeg radability was not reached (at least 60% of the COD in a 10

- day window)

. It was not possible to identify which substances (monom er, dimer, trimer or polymer ) of the Alkanolamine

- acid

- anhydride reaction product were degraded during the 28

- days incubation pe riod.
Conditions : GLP study performed in accordance with OECD 301F and EEC C.4

- D using the manometric Respirometry test

.

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. Adsorption

- desorption

Test substance AAA reaction product (same as the substance being notified)

Results :

These compounds are estimated to cover about 75

- 80% of the dry mat ter of the Alkanolamine

- acid

- anhydride reaction product

. Monomers high to very high mobi lity for b o th monomers in their fully protonated form. Due to deprotonating, the Koc is expected to fall into the highest class for both monomers at environmental pH. The estimated Koc values for diethanolamine are indicating a very high mobility of this m onomer.

Dime rs All dimers are expected to be of very high mobility in soil based on their estimated adsorption coefficients.Trimers Most of the trimers are expected to be of very high mobility in soil except of those ester linked or ester/amide linked compounds where the molecule overall will be positively charged at environmental pH due to protonation of free amino functional groups. The mobility is therefore expected to be lower due to ionic interactions with soil as this will be the relevant binding m echanism to soil.

P olymers The mobility of polymers in soil is expected to decrease with increasing molecular weight
Conditions : The estimation of the adsorption coefficient of Alkanolamine

- acid

- anhydride reaction product to soil was supposed to be perfor med in accordance with OECD 106, OECD 121 and ECC C.19 using different HPLC analysis. Due to the complex mixture of monomers, dimers, trimers and polymers, this approach was not applicable. The adsorption coefficient was therefore estimated using regressi on equations and relating the K oc with the water solubility. A further estimation was performed based on log P ow using regression equation relating the log K oc with log Pow. The EPI Suite software was used to estimate the K oc of the monomers.

15

. Hydrolysis as a Function of pH

Test substance AAA reaction product (same as the substance being notified)

Results:
QSAR based estimates for the acid - and base catalysed hydrolysis rate led to the conclusion that the Alkanolam ine

- acid

- anhydride reaction product will not hydrolyse in a slightly acidic to neutral aquatic environment (pH 4 to pH 7). Under these conditions both ester and amide type functional groups of dimers, trimers and polymers of DEA/acid anhydride reaction product were estimated to be hydrolytically stable. Under alkaline conditions (pH 8 to pH 9), only

.

Condi tions : The determination of hydrolysis of the Alkanolamine

- acid

- anhydride reaction product at different pH values was supposed to be performed in accordance with OECD 111, and ECC C.7 using different HPLC analysis. Due to the complex mixture of8 of 8 the analytical methods were not suitable to follow a hydrolysis of the mixture with exception of the monomers. QSAR based estimates for the acid - and base

- catalysed hydrolysis rate was therefore used.

Summary of additional physical and chemical information Surface tension: The surface tension of the Alkanolamine

- acid

- anhydride reaction product was investigated in an aqueous solution by means of a ring tensiometer in accordance with EEC A.5 and OECD 115 test guidelines and GLP regulations. The surface tension was determined to be 58.0 mN/m at 20.1 0 C ± 0.1 0 C, indicating that the Alkanolamine

- acid

- anhydride reaction product is a surface active substance.

Flash Point : The flash point of the Alkanolamine

- acid

- anhydride reaction product was established using the EEC A.9 test guideline and ASTM standard and in accordance with GLP regulations. The flash point was evaluated to be > 120 0 C using the closed cup method.

Self

- ignition temperat ure : It is evaluated that the water content will evaporate and the dry matter of the Alkanolamine

- acid

- anhydride reaction product will subsequently polymerise upon heating, thereby releasing further water that will evaporate.

Oxidizing properties : Test fo r oxidizing properties has not been performed. The Alkanolamine

- acid

- anhydride reaction product is a

A ccording to Bretherick`s Handbook of Reactive Chemical Hazards none of these components contain groups that may cause an exothermic reaction. In fact, when heated he Alkanolamine

- acid

- anhydride reaction product will polymerise, which is an endothermic reaction.

Full t est reports are presents as attachments to the PMN.