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PBT assessment

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PBT assessment: overall result

Reference
Name:
decan-5-olide
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Decan-5-olide for effects in the environment:

 

The chemical Decan-5-olide (CAS no. 705-86-2) is used as a flavouring agent in food, cosmetics and perfumery etc.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forDecan-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

28-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test item Decan-5-olide (CAS No.705-86-2). The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used for this study. 1 polyseed capsule were added in 500 ml D.I water and then stirred for 1 hour for proper mixing and functioning of inoculum. This gave the bacterial count as 107 to 108 CFU/ml. At the regular interval microbial plating was also performed on agar to confirm the vitality and CFU count of microorganism.The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 73.49% at 20 ± 1°C. Degradation of Sodium Benzoate exceeds 43.37% on 7th days & 58.43% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid. The BOD28 value of test chemical Decan-5-olide was observed to be 1.25 mgO2/mg. ThOD was calculated as 2.53 mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 49.4%. Based on the results, the test item, under the test conditions, was considered to be ultimate inherently biodegradable in nature.

 

Thus, based on the available information of the test chemical Decan-5-olide, it has been concluded that chemical Decan-5-olide is likely to be not persistent (not P) 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 71.1%). In soil, Decan-5-olide was expected to have negligible to slow mobility based upon a Log KOC value of 3.698, respectively. The half-life in soil (17.33 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, 24.9% and 0.205% of the chemical will partition into water and sediment according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (8.66 days in water & 77.916 days in sediment estimated by EPI suite) indicates that the chemical is not persistent in water and sediment & the exposure risk to aquatic and sediment dwelling animals is moderate to low.

 

Hence it has been concluded that chemical Decan-5-olide is not persistent 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 ranges from 22.95 to 40.5, respectively and theoctanol water partition coefficient of the test chemical was determined to be 2.27, 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.

 

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

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substance Decan-5-olide indicates the LC50/EC50 value to be in the range 6.25 to 30.1 mg/L, respectively. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be classified ‘Aquatic Chronic Category 2’ as per the CLP regulation.

 

On the basis ofthe estimated data of long term eco-toxicity data for fish and aq. Invertebrates, the NOEC value was estimated to be ranges from 2.92 to 4.5 mg/l, respectively. 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.