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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
O-isopropyl ethylthiocarbamate
Type of composition:
boundary composition of the substance
State / form:
liquid
>= 85 - < 100 % (w/w)
Reference substance:
O-isopropyl ethylthiocarbamate
Reference substance:
O-isopropyl ethylthiocarbamate
This impurity is considered relevant for the classification and labelling of the substance
Reference substance:
O-isopropyl ethylthiocarbamate
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

Annex XIII of the REACH Regulation (1907/2006) lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), as well as the information that must be considered for the purpose of assessing the P, B, and T properties of the substance. The criteria require that all available information is to be used, employing a weight-of-evidence approach. Substances must meet all three criteria to be considered PBT.

Propan-2-ol (Isopropyl alcohol) and Butan-1-ol (Butyl alcohol) are both reagents used in the manufacture of IPETC/ O-isopropyl ethyl thiocarbamate. Therefore, the Biodegradation in water of Propan-2-ol (Isopropyl alcohol) and Butan-1-ol (Butyl alcohol) need to be considered in the assessment of IPETC/ O-isopropyl ethyl thiocarbamate  .

The results suggest that Propan-2-ol (Isopropyl alcohol) and Butan-1-ol (Butyl alcohol) are readily biodegradable and therefore IPETC/ O-isopropyl ethylthiocarbamate will be readily biodegradable and it is not expected to persist in the environment.

 

Therefore, IPETC/O-isopropyl ethylthiocarbamate is not persistent.

 

Bioaccumulation Assessment:

 

Bioaccumulation is considered to be low for IPETC/ O-isopropyl ethylthiocarbamate which is rapidly metabolised in higher organisms.

 

The estimated Log BCF of IPETC/O-isopropyl ethylthiocarbamate is 1.86 (BCF = 71.8 L/kg wet-wt).This substance has a limited potential to bioaccumulate (based on log Kow used by BCF estimates: 3.32, and predicted bioconcentration factors, log BCF = 1.86 (EPIWIN/BCF Program).

 

Two evidences result in the conclusion that IPETC/ O-isopropyl ethylthiocarbamate is not expected to be B/vB:

 

-The chemical belongs to the thiocarbamate group. In general, thiocarbamates are absorbed via the skin, mucous membranes, respiratory and gastrointestinal tracts, with rapid elimination via expired air and urine.

-Thiocarbamates are also rapidly metabolised, producing either mercapturic acid compounds or compounds that enter the carbon metabolic pool

 

Therefore, IPETC/ O-isopropyl ethylthiocarbamate is not considered to be bioaccumulative.

 

  

Toxicity Assessment:

None of the long-termEC10 or NOECs for marine or freshwater organisms are below 0.01 mg/L. IPETC/ O-isopropyl ethylthiocarbamate is not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3). There is no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC. Therefore IPETC/ O-isopropyl ethylthiocarbamate does not meet the PBT criteria for toxicity.

 

Summary and overall Conclusions on PBT or vPvB:

Properties Based on the data collected and the discussion above,IPETC/ O-isopropyl ethylthiocarbamate does not meet the criteria for either PBT or VPvB as it is readily biodegraded in the environment, has a very low bioaccumulation potential, low chronic aquatic toxicity and is not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.