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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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:

PBT Assessment

The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

Persistence (P) Assessment:

The substance Glycerol monoisostearate (CAS 66085-00-5) is readily biodegradable. Therefore, the substance is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment:

Due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by the low BCF and BAF values calculated for the substance ranging from 0.893 – 36.6 L/kg and from 0.893 - 36.75 L/kg respectively (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Based on the available information, the substance does not meet the B or vB criteria.

Toxicity (T) Assessment:

Glycerol monoisostearate (CAS 66085-00-5) is considered to be not toxic. The assessment is based on a read across to a chronic toxicity study on Daphnia magna according to OECD 211, determining a NOEC (21 d) > 1 mg/L. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. The criteria for “T” based on mammalian effects are therefore not met.