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Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

According to the ECHA guidance on PBT/vPvB assessment (version 3.0, 2017) Acylglutamate CT-12-T is regarded as not being persistent (P) or very persistent (vP), not bioaccumulative (B) or very bioaccumulative (vB) and not toxic (T); therefore the substance is not PBT or vPvB.

Persistence Assessment

Acylglutamate CT-12-T is considered to be not persistent (P) or very persistent (vP) as, under the OECD 301D test conditions, the percentage biodegradation of the test material reached a mean of 70.2 % after 28 days (based on the measured COD of the test material). Although in the test the substance failed the 10-day window, the substance is not expected to be persistent as (according to the ECHA guidance on PBT/vPvB assessment (p. 115, version 3.0, 2017)) all constituents have sufficiently similar structures and the test conducted determined that the test item met the stringent ultimate ready biodegradation test criterion (>60 % in 28 days).

Bioaccumulation Assessment

Based on the weighted average log Pow of -1.58 and on the constituents’ log Pow values (ranging from -3.58 to 0.35), the substance does not fulfil the bioaccumulative (B) and very bioaccumulative (vB) criteria (ECHA guidance on PBT/vPvB assessment, version 3.0, 2017).

Toxicity Assessment

The substance does not fulfil the toxicity (T) criterion as it is not classified as H350, H340, H372, H373, H350i, H360 and/or H361, none of the acute aquatic ecotoxicity LC50 and EC50 endpoints are < 0.01 mg/L, the weighted average log Pow of -1.58 and the constituents’ log Pow values ranging from -3.58 to 0.35 are all less than the trigger value of > 4.5, the chronic endpoint (derived for a 72 hr algal study) NOEC of 1.51 mg/l is greater than trigger value of <0.01 mg/l and there is no other evidence that suggests chronic toxicity (as identified by the substance meeting the criteria for classification: STOT RE 1, or STOT RE 2 according to the CLP Regulation).