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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction products of N-methyldiethanolamine and Boric Acid (1:1.5)
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence: the substance is expected to be hydrolytically stable and it is not readily biodegradable by microorganisms. Persistence is potential.

Bioaccumulation: the substance has a high affinity to the water phase (log POW = -1.1) which excludes the potential for bioaccumulation in organisms. Therefore, criterion for bioaccumulation is not met.

Toxicity: the substance is not classified for aquatic toxicity according to the CLP Regulation (EC 1272/2008); the substance is not classified as carcinogenic or mutagenic, however, the NOAEL and LOAEL for toxicity to development could not be determined as developmental toxicity was observed at all test concentrations tested (100 - 800 mg/kg bw/day); the substace is not classified for chronic toxicity or specific organ toxicity. The criteria for toxicity are met.

For these reasons, according to REACH regulation, Annex XIII (section 1), the substance does not meet the criteria for PBT classification, since the criteria for toxicity (T) was satisfied; persistence (P) is considered likely yet inconclusive; and the criterion for bioaccumulation (B) was not met.

Likely routes of exposure:

Due to its high affinity to the hydrophilic phase and because bioaccumulation is not significant, exposure from the consumption of contaminated water seems to be the most relevant route.