Registration Dossier
Registration Dossier
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EC number: 223-786-9 | CAS number: 4073-98-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- further information relevant for the PBT assessment is necessary
- Justification:
4,4’-methylenebis(2,6-xylidine) (CAS 4073-98-7) was assessed to be not readily biodegradable based on the data for N,N,N’,N’-tetramethyl-4,4’-methylenedianiline (CAS 101-61-1) and 4,4’-methylenedi-o-toluidine (CAS 838-88-0). Further, the substance is considered to be hydrolytically stable. Consequently, based on the available data on abiotic and biotic degradation, the substance should be considered persistent (potentially “P”) and potentially very persistent (potentially “vP”), in absence of any other data as the screening-criteria for persistence are fulfilled.
Bioaccumulation in organisms is not to be expected based on an estimated log Kow of 4.37. The calculated BCF values are significantly lower than the Annex XIII criterion for B-substances of BCF = 2000 (BCFBAF v3.01: Meylan et al., 1997/1999: BCF = 355; Arnot & Gobas, 2003, incl. biotransformation: BCF = 42) indicating that 4,4’-methylenebis(2,6-xylidine) (CAS 4073-98-7) is probably not B/vB.
With respect to the aquatic toxicity, the results of the available short-term studies show that the L(E)C50 values for fish, aquatic invertebrates and algae are greater than the screening criterion of 0.01 mg/L. The lowest acute value is 0.531 mg/L. Long-term toxicity data are only available for algae. The available study for algae gave an ErC10 value of greater than 0.01 mg/L (0.26 mg/L). As both substances are officially classified as carcinogenic (Carc. Cat. 2/Carc. 1B), the target substance is assessed to be T.
A final conclusion cannot be drawn based on the available data as information on persistence is not definite.
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