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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Because of rapid hydrolysis of MMDS (fully hydrolized within 104 minutes), the environmental relevant substances are the hydrolysis substances MDSA and Formaldehyde. Therefore the PBT assessment was performed on MDSA and formaldehyde separately.


MMDS was experimentally tested for biodegradation in a modified Sturm test (according to test guidelines OECD 301 B and EC C.4) with activated sludge under aerobic conditions. Since MMDS is hydrolytically unstable, it is assumed that in this test the biodegradation of the hydrolysis products MDSA and formaldehyde is taking place. Significant degradation of the test substance (mean of 54%) was observed after 28 days.

Furthermore, the BIOWIN (both 2 and 3) models on MDSA and formaldehyde revealed that the screening criteria for P were not met.

It is therefore concluded that the hydrolysis substances are not persistent (P) or very persistent (vP).


For MDSA and formaldehyde, QSAR estimations show that the log Kow will be very low (-1.485 and 0.35, resp.). Therefore, it can be concluded that the substances do not fulfill the screening criteria for bioaccumulating (B) or very bioaccumulating (vB).


Short-term aquatic toxicity tests with the hydrolysis substance MDSA on algae, daphnia and fish revealed L(E)C50 of 42 mg/L or higher. Therefore, the screening criteria for T were not met. Formaldehyde is not classified for the environment but is classified as Carcinogenic 2, so should be defined as Toxic (T).