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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
stoddard solvent
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
stoddard solvent
Reference substance:
stoddard solvent
Name:
stoddard solvent
Type of composition:
legal entity composition of the substance
State / form:
liquid
Related composition:
stoddard solvent
Reference substance:
stoddard solvent
Reference substance:
stoddard solvent
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.

 

Persistence Assessment:

  

The BIOWIN QSAR predicts that the substance Stoddard solvent will be readily biodegradable.

Data of studies are demonstrating rapid biodegradation of Stoddard solvent under aerobic conditions.

The result is that it was achieved 63% degradation after 28 days. This test was carried out according to the guidelines of OECD Guide-line 301 B "Ready Biodegradability: Modified Sturm Test (CO2 evolution)"

Stone & Watkinson (1982) conducted test for ready biodegradability of low aromatic Stoddard solvent using OECD test guidelines 301B. 

The formula of the Stoddard solvent was considered as C10H22 (relative molecular mass, 142), leading to a theoretical oxygen demand of 3.49 mg oxygen per mg and a theoretical carbon dioxide evolution of 3.10 mg  CO2 per mg. The Stoddard solvent was degraded by 55-63% in the Stum test   (guideline 301B). Stoddard solvent was considered to be readily degradable

 

        

Therefore,Stoddard solvent is not persistent.

 

Bioaccumulation Assessment:

 

QSAR estimation using the BCFBAF v3.01 of the EPISUITE 4.1 indicate that the BCF of Stoddard solvent is 39.66 L/kg wet-wt.

This is well below the threshold for Bioaccumulation (B) for the PBT determination.

The octanol/water partition coefficient (log Pow) of Stoddard solvent has been found to be 3.5 to 6.4.

This indicates a moderate potential for bioaccumulation by organisms from water and a likelihood of partitioning to fat within organisms. 

 

A reliable QSAR method predicts a value for the partition co-efficient (logKow) of 5.25 for this substance.

The sorption to soil/sediment in the environment will tend to reduce bioavailability and, therefore, uptake of Stoddard solvent components. 

 

 

There are no studies quantifying bioconcentration factors for Stoddard solvent. No information is available on the bioconcentration of Stoddard solvent directly.

However, organisms have been found to accumulate the hydrocarbons present in fuel oils, some of which occur Stoddard solvent.

 

Therefore, Stoddard solvent is not considered to be bioaccumulative.

 

  

 

Toxicity Assessment:

None of the long-term EC10 or NOECs for marine or freshwater organisms are below 0.01 mg/L. Stoddard solvent (benzene < 0.1 w/w%) is not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3).

Classification with Xn; R48/20 or STOT RE 1, H372 was added and is to be considered as a toxicity end-point of serious nature as impaired CNS performance and the diverse pattern of CNS symptoms and the irreversible nature of these effects should be considered as adverse effects of concern.

Stoddard solvent is considered to be T on the basis of CNS symptoms and the irreversible nature

 

 

Summary and overall Conclusions on PBT or vPvB:

Properties Based on the data collected and the discussion above, Stoddard solvent 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.