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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Methyl abietate for effects in the environment:

 

The chemical Methyl abietate (CAS no. 127-25-3) is used as a fragrance agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for the substance Methyl abietate. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradability of test chemical methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate( CAS no. 127 -25 -3) is predicted using OECD QSAR tool box v.3.3 using log Kow as primary descriptor. The percent biodegradability estimated of test chemical methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate is 28.39 % by considering BOD as parameter and microorganism as inoculum in 28 days. Therefore, it is concluded that this test chemical methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate is not readily biodegradable.

 

Another prediction done by using Estimation Programs Interface Suite (EPI suite, 2017) estimated biodegradation potential of the test compound methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate (CAS No: 127 -25 -3) in the presence of mixed populations of environmental microorganisms 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 methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate is expected to be not readily biodegradable.

 

Experimental study on read across substances (CAS: 510-15-6; 25155-23-1 and 8050-31-5) also indicate the substances to be not readily biodegradable.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 70.01%).Thehalf-life in soil (120 days estimated by EPI suite) indicates that the chemical is not persistent in soil.

 

If released in to the environment, 24.9 and 5.0% of the chemical will partition into sediment and water, respectively according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (541.6 days in sediment and 60 days in water as estimated by EPI suite) indicates that the substance is persistent in both compartments.

 

Although the half-life values in sediment suggest classification as very persistent (vP), the substance is classified only as persistent (P) since only estimated half-life values are available for the same.

 

Hence it has been concluded that the substance Methyl abietate is likely to be persistent in nature.  

 

Bioaccumulation assessment

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

 

The estimated BCF value from various databases was determined to be in the range 13140 - 19675 and theoctanol water partition coefficient of the test chemical is 6.75 which is more than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a moderate to high 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

 

As per Column 2 (Annex VIII) of the REACH regulation, a study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water. The test substance was determined to be highly insoluble in water. 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 fulfils the P and B criterion but does not fulfil the T criterion and has therefore not been classified as a PBT compound within Annex XIII.