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PBT assessment

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PBT assessment: overall result

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Name:
Boundary composition_3-Chloro-2-hydroxypropyltrimethylammonium chloride
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Name:
Legal entity composition_3-Chloro-2-hydroxypropyltrimethylammonium chloride
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

From the two available guideline studies (modified Sturm test (OECD 301B) and STP simulation test (OECD 303A)) it can be concluded that CHPTAC is not readily biodegradable.

In other, non-standard tests some removal of CHPTAC has been observed. The conclusion of the ESR Risk Assessment for CHPTAC was that the substance could be considered "inherently biodegradable not meeting specific criteria (cited from European Union Risk Assessment Report on CAS # 3327-22-8, 2008).

Nevertheless, the test substance is considered to be vP (and P).

CHPTAC has a partition coefficient (log Kow) < -1.5 hence lacks any bioaccumulation potential.

Daphnia magna was identified as most sensitive organism in the tests for aquatic toxicity with a 21-d NOEC of 0.51 mg/L (nominal).

Based on these data, the substance does fulfil the REACH Annex XIII criteria for non-T properties (EC10/NOEC ≥ 0.01 mg/L for marine/freshwater organisms (long-term toxicity)).

 

Furthermore, the substance is neither classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A or 1B, or 2), nor is there other evidence of chronic toxicity, as identified by the classifications "STOT RE 1, or STOT RE 2" according to EU CLP Regulation.

In conclusion, CHPTAC is not readily biodegradable, not bioaccumulating, and does not fulfil any of the T-criteria. Therefore, the substance does not qualify for classification as PBT.