Registration Dossier
Registration Dossier
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EC number: 214-300-6 | CAS number: 1120-21-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
8.1. Assessment of PBT/vPvB Properties
8.1.1. Persistences (P) assessment
A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation).
Several biodegradation studies measured more than 70% degradation after 28 days following OECD Guideline 301 (Enichem - Istituto Guido Donegani 1994a&b; 1995; ExxonMobil1996a).
Based on the available measured data, the substance is readily biodegradable. Therefore, based on initial persistence screening the “Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” are not expected to meet the Persistent (P) or very Persistent (vP) criteria. Undecane is not considered a persistent substance.
8.1.2. Bioaccumulation (B) assessment
An evaluation of representative hydrocarbon structures indicates only few structures (C13 and C14 n-paraffins) may meet the Bioaccumulative (B), but not the very bioaccumulative (vB) criteria (see CONCAWE, 2010b - PBT assessment document attached to IUCLID section 13). Moreover, calculations of BCF using EPIWIN program showed that the BCF of undecane (337.8) is largely lower than the trigger values for bioaccumulative (2000) or very bioaccumlative (5000) substance.
Therefore, based on the screening criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008), Undecane cannot be considered a bioaccumulative substance.
8.1.3. Toxicity (T) assessment
8.1.3.1 Environmental Toxicity
Hydrocarbons, C10-C13, n-alkanes, <2% aromatics, were not identified as PB or vPvB, therefore a toxicity assessment is not needed.
None of the measured or calculated data for the “Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” exceed the criteria for toxicity stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008). Therefore, Undecane is not considered toxic (T).
8.1.3.2 Human Health Hazards Assessment (T)
Carcinogenicity
The available data indicate that “Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” do not warrant classification for carcinogenicity under GHS/CLP.
Mutagenicity
“Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” are not genotoxic or mutagenic and do not warrant classification for carcinogenicity under GHS/CLP.
Reproductive Toxicity
The available data indicate that Undecane is not toxic to reproduction and does not warrant classification under GHS/CLP.
Conclusion
“Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” are considered not to be T on the basis of the data relevant to human health. Therefore, it is considered that Undecane does not fulfill the T criterion.
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