Registration Dossier
Registration Dossier
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EC number: 287-828-8 | CAS number: 85586-25-0
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- Reference substance:
- Fatty acids, rape-oil, Me esters (erucic acid rich)
- 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. Fatty acids, rape-oil, ME esters (CAS 85586-25-0) is readily biodegradable (87% 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:
An evaluation of the bioaccumulation potential of Fatty acids, rape-oil, Me esters (CAS 85586-25-0) is presented in chapter 5.3 indicating that bioaccumulation is expected to be low. Due to its ready biodegradability, rapid metabolism in fish and the estimated BCF/BAF values, this substance is likely to show low bioaccumulation potential. Based on the above information, Fatty acids, rape-oil, Me esters does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.
Toxicity (T) Assessment:
The long-term no-observed effect concentrations (NOEC value) reported in the test conducted with aquatic invertebrates is higher than 0.01 mg/L (read across to CAS 308065-15-8), 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, Fatty acids, rape-oil, Me esters (CAS 85586-25-0) does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.
In conclusion, Fatty acids, rape-oil, Me esters (CAS No. 85586-25-0) is considered not to be PBT or vPvB.
Reference
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