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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Propylene glycol methyl ether does not have PBT or vPvB Properties.

Propylene glycol methyl ether meets the criteria for ready biodegradation, according to all aerobic biodegradation screening studies except in the “Closed Bottle Test” (OECD Guide Line 301D) where a biodegradation of only 2 to 4% occurred after 28 days (the biodegradation is expressed as theoretical oxygen demand). However, a modified Sturm test (Directive 84/449/EEC, C.5) was performed in the same series along with a microbial inhibition test on a pure strain of Ps. Fluorescens. A degradation of 65 to 69% after 28 days was observed. The absence of degradation in the “Closed Bottle Test” could result from incapability of the particular strain of microorganism to adapt to the substance. This assumption is confirmed by the presence of lag periods in all of the tests. In conclusion, propylene glycol methyl ether can be considered as readily biodegradable under aerobic conditions. Hence, the test substance does not fulfill the criteria for persistency as outlined in Annex XIII of the REACH legislation of December 2006.

Propylene glycol methyl ether has a low log Kow (log Kow < 1) and is readily biodegradable, which indicates that propylene glycol methyl ether offers little potential for bioconcentration in aquatic organisms. Therefore it does not fulfill the criteria for bioaccumulation as outlined in Annex XIII of REACH legislation of December 2006.

Measured aquatic toxicity data indicate that propylene glycol methyl ether presents a low toxicity hazard to aquatic species. All EC50/LC50 values (fish, daphnia and algae) are greater than 100 mg/l.

Propylene glycol methyl ether is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008.