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PBT assessment

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PBT assessment: overall result

Reference
Name:
Dodecane
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
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. Dodecane, belonging to this category is not considered a persistent substance.

 

8.1.2. Bioaccumulation (B) assessment

An evaluation of representative hydrocarbon structures indicates only few structures (C13 and C14n-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 dodecane (790.9) 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), Dodecane cannot be considered a bioaccumulative substance.

 

8.1.3. Toxicity (T) assessment

8.1.3.1 Environmental Toxicity

Dodecane was 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 the members of this category are not considered toxic (T).

8.1.3.2 Human Health Hazards Assessment (T)

Carcinogenicity

The available data indicate that members of Category “Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Mutagenicity

“Hydrocarbons, C9-C14, aliphatics (≤2% aromatics)” are not genotoxic or mutagenic and do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Reproductive Toxicity

The available data indicate that members of this category are not toxic to reproduction and do not warrant classification under Dir 67/548/EEC or 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 Dodecane, belonging to this category, does not fulfill the T criterion.