Registration Dossier
Registration Dossier
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EC number: 215-951-9 | CAS number: 1459-93-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence: Screening-level data indicate that dimethyl isophthalate (DMIP) is readily biodegradable, and therefore it may be concluded that the substance is not persistent (not P) and not very persistent (not vP).
Bioaccumulation: Screening-level data indicate that DMIP is not bioaccumulative (not B) and not very bioaccumulative (not vB). These screening-level determinations are based on an experimentally-determined log Kowof 2.10, which is substantially below the screening criterion (log Kow≤ 4.5) for both “not B” and “not vB”. This screening-level indication is supported by the predicted bioconcentration factor of 11.29 L/kg (as predicted by a valid QSAR model), which is substantially below the definitive criteria for “B” (> 2,000 L/kg) and “vB” (>5,000 L/kg).
Toxicity: A definitive determination regarding the mammalian toxicity of the substance indicates that the substance is not toxic; DMIP has not been classified as a "carcinogenic, mutagenic or toxic for reproduction toxicant" (CMR) and has not been classified as "T, R48", "Xn, R48" or "STOT-RE" with respect to chronic exposures. The short-term screening-level data for aquatic toxicity (i.e., ErC50 (algae) = 13.9 mg/L > 0.1 mg/L) indicate that the substance is “presumably not T” with respect to aquatic toxicity; however, this is not a definitive determination as long-term aquatic toxicity testing data are not available.
Conclusions: Therefore, although a complete definitive determination cannot be made with respect to three endpoints (P, vP, and T), screening level criteria indicate that DMIP is “not P”, “not vP”, “not B”, “not vB”, and “not T”. It is not necessary to meet definitive criteria for all five endpoints to make the determinations as to whether the substance is “not PBT” and “not vPvB”. The determination based on screening criteria only requires that “each of the three properties persistency, bioaccumulation and toxicity need to be considered in conjunction” (Chapter R.11, “PBT Assessment”,Guidance on information requirements and chemical safety assessment, ECHA, May 2008, Section R.11.1.2.2, p. 13.
In summary, DMIP is “not PBT” (not P, not B, not T) and is “not vPvB” (not vP, not vB).
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