Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide (CAS no. 39711-79-0) for effects in the environment:

The test chemical N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide (CAS no. 39711-79-0) is used in air care products, biocides (e.g. disinfectants, pest control products), perfumes and fragrances, polishes and waxes and cosmetics and personal care products. The test chemical herein critically and independently evaluated for the PBT.

The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forN-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models.

 

1. Persistence assessment

 

The tested substance doesn’t meet the P criterion within Annex XIII based on the assessment that here follows:

 

1.1.Overall degradability

 

By reviewing all the available biodegradation studies for the target chemical, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide (CAS no. 39711-79-0). The extended closed bottle test reveals that test chemical is has degraded only up to 33% in the 42 days. By which it is categorised into primary inherent biodegradable chemical.

In conclusion, the chemical was estimated to be non-persistent in water, because of it biodegradable nature

1.2 Environmental fate and exposure risk

The test chemical 39711-79-0 if released intentionally or un intentionally into the environmental media. It is predicted that the test chemical would mostly accumulate in the soil up to 81.6 % followed by water (17.1%) and sediment (1.04%).

 

Table 2:Summary of estimated half-life and Mackay Fugacity model (level III) in freshwater, sediment and soil by EPI suite version 4.1:

 

Medium

Predicted half-life

Mackay fugacity model level III

fresh- or estuarine water

37.5 days

 17.1%

fresh- or estuarine sediment

337.5 days

1.04%

soil

75 days

81.6%

 

The test chemical, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide was estimated to be primary inherent biodegradable in nature, and it could be very persistence in soil. As the values obtained are predicted, thus it can be considered as persistent chemical rather than very persistent.

 

 

2. Bioaccumulation assessment

 

The tested substance doesn’t meet the B criterion within Annex XIII based on the assessment that here follows:

I.             Section 4.7, of Partition coefficient was studied based on the OECD 117 guidelines. The Reverse Phase High Performance Liquid Chromatographic method has been applied to determine the log Kow. The Log Kow value of the test chemical N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide was obtained to be 2.902 ± 0.001, at 25°C. On the basis of this value, test chemical N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide can be considered to have hydrophilic nature.

By relying on the data, CAS 39711-79-0 chemical cannot be classified into Bio accumulative category.

 

3.    Toxicity assessment

 

The tested substance doesn’t meet the T criterion within Annex XIII based on the assessment that here follows:

 

3.1. Mammals

 

The substance didn’t fulfil the criteria for the mammalian toxicity, neither CMR nor STOT RE as per ANNEX XIII of PBT classification.

 

3.2. Freshwater organisms

Test Substance was used to investigate for its adverse effects induced to the aquatic species (Fish, Daphnia and algae). The studies were conducted by following the OECD guidelines. The outcomes obtained from the studies states that test chemical is hazardous in nature and categorised into aquatic chronic category 3, with the toxic values ranging from 50 - <100 mg/L.

By considering the toxic values it can be presumed that the NOEC values for the long-term exposure would be not lower than the threshold value 0.01 mg/L. Thus, it can be classified as non-toxic chemical as per Annex XIII for PBT classification.   

 

Overall conclusion about Persistence, Bioaccumulation and Toxicity (PBT).

Based on critical, independent and collective evaluation of information summarized herein, the tested compound didn’t meet P,B and T criterion within Annex XIII. Hence, the tested compound has not been classified as a PBT compound within Annex XIII.