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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Undecan-2-one
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Undecan-2-one
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 2-Undecanone for effects in the environment:

 

The chemical 2-Undecanone (CAS no. 112-12-9) isused as a solvent in the production of vinyl resins, nitrocellulose, and synthetic rubber; as a flavoring agent. It is also used to make some synthetic essential oils and as a fragrance in soaps, detergents, creams, lotions, and perfumes etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 2-Undecanone (CAS no. 112-12-9). The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Overall on the basis of various experimental results of biodegradation studies (from reliable handbook, peer reviewed journals and secondary source) for the test chemical2-Undecanone (CAS no. 112-12-9), it indicates thatchemical 2-Undecanonewas evaluated to be readily biodegradable in water and thus likely to be not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The estimated BCF value from handbook and modelling databases was evaluated to beranges from 9.8 to 873.9 dimensionless, respectivelyand theoctanol water partition coefficient of the test chemical was estimated to be 3.69 at 25°C, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance fulfils the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substance 2-Undecanone (CAS no. 112-12-9) indicates the LC50/EC50 value to be in the range 0.23 to 7.3 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be classified in ‘aquatic acute 1/chronic 1 category’ as per the CLP regulation.

There are no available long-term toxicity evaluations forchemical2-Undecanone. Thus, by speculation, long-term NOEC for aquatic organisms were expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

The chemical was therefore considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound fulfils the T criterion, but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.