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EC number: 250-705-4
CAS number: 31566-31-1
According to Regulation (EC) No. 1907/2006, a substance must fulfil all
three criteria for persistence, bioaccumulation and toxicity to be
considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil
the criteria for persistence and bioaccumulation stated in part 2 of
Annex XIII to be considered vPvB.
Data for the definitive conclusion on the PBT or vPvB properties
according to the criteria set in Regulation (EC) No. 1907/2006, Annex
XIII, parts 1 and 2, are not available for all three criteria. Thus, the
screening criteria given in the ‘Guidance on information requirements
and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA,
2012) are used as surrogate information to decide whether the substance
may potentially fulfil the PBT or vPvB criteria.
Persistence (P) Assessment:
A valid screening criterion to evaluate persistence (P) is the potential
of a substance for ready biodegradability.Stearic acid, monoester
with glycerol (CAS 31566-31-1) is readily biodegradable.
Therefore, it 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 rapid environmental biodegradation and metabolization via
enzymatic hydrolysis of the Glycerides category members, a relevant
uptake and bioaccumulation in aquatic organisms is not expected.
Enzymatic breakdown will initially lead to the free fatty acid and
glycerol. From literature it is well known, that these hydrolysis
products will be metabolised and excreted in fish effectively (Tocher,
2003). This is supported by calculated BCF values ranging from 0.89-57.1
L/kg within the category (BCFBAF v3.01, Arnot-Gobas, including
biotransformation, upper trophic). Experimental data on glycerol
tristearate (CAS No. 555-43-1, category member) showed a BCF value in
fish < 10 (Freitag, 1985). Please refer to IUCLID Section 5.3.1 for a
detailed overview on bioaccumulation of the Glycerides category members.
Based on the available information, the substance does not meet the B or
Toxicity (T) Assessment:
The available data on short-term and long-term
toxicity indicate that the Glycerides category members are not
chronically toxic. All reported no-observed effect concentrations (NOEC
values) are higher than 0.01 mg/L. Furthermore Stearic
acid, monoester with glycerol (CAS 31566-31-1) is
not classified as carcinogenic, mutagenic or toxic for reproduction nor
is there any evidence of chronic toxicity according to the 2nd ATP of
Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC.Thus,
the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are
not met and the substance is considered to be not T.
In conclusion,Stearic acid, monoester with glycerol (CAS
31566-31-1) is considered not to be PBT or vPvB.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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