Cinnamaldehyde

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Cinnamaldehyde for effects in the environment:

 

The chemical Cinnamaldehyde (CAS no. 104 -55 -2) is used as a flavouring agent in foods, beverages, chewing gum, dental products and as a fragrance agent in perfumes, cosmetics etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forCinnamaldehyde. 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

On the basis of various experimental results of biodegradation studies conducted as per the OECD test guideline for the target chemical Cinnamaldehyde (CAS no. 104-55-2), overall the percentage degradation of the chemical ranges from 61.02% to 100% after 28 days, which indicates that chemical Cinnamaldehyde was considered to be readily biodegradable in water and thus likely to be not persistent (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 67.6%). In soil, Cinnamaldehyde was expected to have moderate mobility based upon a Log KOC value of 1.98 ± 0.003 at 25°C determined as per the OECD test guideline 121 and from other reliable source, logKoc value was evaluated to be 1.568. 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, 31.8 of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2018). 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 0.107% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Cinnamaldehyde 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:

 

The estimated BCF value from authoritative database was evaluated to be 8.0 and theoctanol water partition coefficient of the test chemical was determined to be 2.1065±0.0017at 25°C as per the OECD guideline no. 117 & from handbook, it was evaluated to be 1.88 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 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 substanceCinnamaldehyde(CAS no. 104-55-2) indicates the LC50/EC50 value to be in the range 1.67 to 31.6 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since, the chemical is readily biodegradable in water, chemical was considered as non-toxic and hence, considered to be ‘not classified’ as per the CLP regulation.

 

On the basis of the available long term toxicity data of fish and aquatic invertebrates forchemicalCinnamaldehyde, the 28 days NOEC was evaluated to be 15.159 mg/l & 21 days EC50 value was determined to be 0.402 mg/l. Thus, chemical can be considered to be toxic and hence, considered to be classified in ‘aquatic chronic category 3’ as per the CLP regulation.

 

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.