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PBT assessment

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PBT assessment: overall result

Reference
Name:
dodecan-5-olide
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
dodecan-5-olide
PBT status:
the substance is not PBT / vPvB
Justification:

Classification ofDodecan-5-olidefor effects in the environment:

 

The chemical Dodecan-5-olide(CAS no. 713-95-1) is used as a flavouring agent in foods and as a fragrances in cosmetics.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Dodecan-5-olide. 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

In a prediction done using the Estimation Programs Interface Suite, the biodegradation potential of the test chemical in the presence of mixed populations of environmental microorganisms was predicted. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that test chemical is expected to be readily biodegradable.

 

Experimental results from the read across substances also indicate that they are readily biodegradable.

 

Thus, based on the above available information, it has been concludedthat chemical Dodecan-5-olideis likely to be not persistent in nature.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to be 78.3%). In soil,Dodecan-5-olidewas expected to have slow mobility based upon a Log KOC value ranging from 2.4 to 3.3, respectively. The half-life in soil (30 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

 

If released in to the environment, 18.9% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% i.e reported as 0.508% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded thatchemicalDodecan-5-olideis 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:

 

Theestimated BCF value from authoritative database was determined to be in the range 10.8 to 264, respectively and the octanol water partition coefficient of the test chemical was determined to be ranges from 3.48 to 3.55, respectively, 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.

 

Thus, based on the available information, chemicalDodecan-5-olide is likely to be non-bioaccumulative (not B) in nature.

 

Toxicity assessment

The tested substance does not fulfil 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

On the basis of the various experimental studies of short term eco-toxicity data for fish, aq. invertebrates and algae of the structurally and functionally similar read across chemical (including the biodegradability of read across chemical) and applying the weight of evidence approach, the LC50/EC50 value was determined to be ranges from 2.4 to 230 mg/l, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since the test chemical is readily biodegradable in nature, chemical Dodecan-5-olide is considered to be non-toxic and hence, considered to be ‘not classified’ as per the CLP classification criteria.

 

There are no available long-term toxicity evaluations forDodecan-5-olide(CAS no. 713-95-1). By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

 

The chemical was therefore not 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 does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.