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EC number: 701-173-1
CAS number: -
Comparing with the Criteria of Annex XIII, an assessment of the
PBT status of MDI has been made using all available data. The
information available suggests that MDI does not meet the PBT screening
criteria as outlined in Annex XIII of Directive 2006/121/EC.
The results from the
inherently biodegradation test indicate that PMDI is not biodegradable.
Significant and substantial
abiotic degradation by means of hydrolysis has been confirmed for PMDI
and its hydrolysis transformation products have been assessed. The
half-lives obtained for PMDI are much lower than the P(vP) criterion of t1/2>
40 (60) days. Based on experimental hydrolysis and indirect photolysis
half-lives, PMDI is not considered to be persistent in the environment
and is identified as not P. Based on the justification in
the category approach, it is assumed that all MDI analogues included in
the category are not P.
Conclusion for the B
Although MDI has a high
measured log Kow value (4.51), a full bioaccumulation test with 4,4’-MDI
indicated that the bioaccumulation potential is low. The expected
hydrolysis product MDA has, based on its measured log Kow value of
1.55 and predicted BCF of <14 L/kg, no or a low bioaccumulation
potential. Due to the
fast hydrolysis, exposure of the environment to the substance is
unlikely or very low.
Considering the above
together with the fast hydrolysis of MDI, there is no potential for
significant bioaccumulation possible. Hence, 4,4’-MDI does not fulfil
the requirements for the B criterion and is identified as not B.
Based on the justification in the category approach, it is assumed that
all MDI analogues included in the category are not B.
Conclusion for the T
Based on the effect
concentrations determined in the aquatic toxicity tests with PMDI, MDI
does not fulfil the T criteria. It was noted that the concentrations
tested were far above the estimated water solubility of the MDI
substances (i.e. 7.5 mg/L). However, the water solubility limit of MDI
is far above the criteria for T and on the basis of aquatic toxicity
tests MDI is identified as not T. However, according to Annex I of
67/548/EEC MDI is classified as Xn, R48, which automatically triggers a
T. Based on this classification MDI is identified as T.
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