O-isobutyl ethylthiocarbamate

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

O-isobutyl ethylthiocarbamate

Type of composition:

boundary composition of the substance

State / form:

liquid

> 90 - < 100 % (w/w)

Reference substance:

O-isobutyl ethylthiocarbamate

Reference substance:

O-isobutyl ethylthiocarbamate

This impurity is considered relevant for the classification and labelling of the substance

Reference 2

Name:

O-isobutyl ethylthiocarbamate

Type of composition:

legal entity composition of the substance

State / form:

liquid

Related composition:

O-isobutyl ethylthiocarbamate

Reference substance:

O-isobutyl ethylthiocarbamate

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.

 

Isobutyl alcohol is reagents used in the manufacture of O-isobutyl ethylthiocarbamate. Therefore, the Biodegradation in water of Isobutyl alcohol need to be considered in the assessment of O-isobutyl ethylthiocarbamate . 

The ready biodegradability of the substance was examined. After 28 days, approximately 74% of the test material was degraded.

The results suggest that Isobutyl alcohol is readily biodegradable and therefore O-isobutyl ethylthiocarbamate will be readily biodegradable and it is not expected to persist in the environment.

 

Therefore O-isobutyl ethylthiocarbamate is not persistent.

 

Bioaccumulation Assessment:

 

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

 

This substance has a limited potential to bioaccumulate (based on log Kow used by BCF estimates: 3.81, and predicted bioconcentration factors, log BCF = 2.18  (EPIWIN/BCF Program). The estimated BCF of 151.4 L/kg wet-wt was measured by calculation from EPI SuiteTM v4.1 Program.

 

  

Two evidences result in the conclusion that O-isobutyl 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, O-isobutyl ethylthiocarbamate is not considered to be bioaccumulative.

 

  

Toxicity Assessment:

None of the long-termEC10 orNOECs for marine or freshwater organisms are below 0.01 mg/L. O-isobutyl 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 O-isobutyl 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, O-isobutyl 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.