Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

Reference
Name:
Glycerides, rape-oil mono-, di- and tri-, hydrogenated
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

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, 2008) 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. Glycerides, rape-oil mono-, di- and tri-, hydrogenated (CAS 91744-94-4) is considered to be readily biodegradable (69-95% biodegradation in 28 days). 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:

No data available

 

Toxicity (T) Assessment:

The long-term no-observed effect concentrations (NOEC values) reported in the tests conducted with aquatic invertebrates and algae are higher than 0.01 mg/L, and the substance 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. Therefore,

Glycerides, rape-oil mono-, di- and tri-, hydrogenated (CAS 91744-94-4) does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

 

In conclusion, Glycerides, rape-oil mono-, di- and tri-, hydrogenated (CAS 91744-94-4) is considered not to be PBT or vPvB.