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PBT assessment

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PBT assessment: overall result

PBT status:
PBT assessment does not apply
Justification:

An evaluation of the inherent properties of GC is performed against the Annex XIII criteria of the REACH Regulation. As insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.

The biodegradability of glycerine carbonate was determined using the CO2evolution method (according to OECD 301 B). Based on the results, glycerine carbonate can be classified as readily biodegradable, and does not have P and vP properties.

A BCF of approximately 1 was determined (Reimer et al., 2003). In addition, a low Kow was calculated (-1.39). Therefore, it can be concluded that glycerine carbonate does not have a bioaccumulative potential (not B/not vB)

The available evidence on aquatic toxicity is not sufficient for an assessment based on the Annex XIII criteria for toxicity (T).

Only acute toxicity data for aquatic organisms are available:

- 48-h EC50 toDaphnia magnawith glycerol is 1955 mg/L.

- 8d-EC3 to the freshwater algaMicrocystis aeruginosawith glycerol is2900 mg/L

- 96-h LC50 to fish > 1040 mg/L

Based on these results, all acute median effect concentrations appear to be > 0.1 mg/L (which is the cut-off level used as screening criteria for the T in the PBT assessment (see table R.11-4 of ECHA guidance on PBT assessment). 

Finally, the substance does not fulfill the screening criteria based on acute toxicity for being considered as T, and does not fulfill two of the three Annex XIII criteria (classification for hazardous properties for human health).

- Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC (or the DSD) or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 (or CLP Regulation): not classified as CMR.

- No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008: no other evidence of chronic toxicity as identified by classification.

Based on the above, it can be concluded thatthe substance is not T. Based on theabovementioned data, glycerine carbonate should not be considered as a PBT/vPvB substance.

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