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PBT assessment

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PBT assessment: overall result

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Name:
Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Name:
Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment of Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate (EC 944-336-4) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistence Assessment

One OECD 301 screening study is available investigating the ready biodegradability of the substance. After 34 d the substance reached a degradation of 9-10%. Thus, the substance does not fulfill the criteria for ready biodegradability and is therefore considered to be potentially P/vP.

 

Bioaccumulation Assessment

In accordance with ECHA Guidance R.11 (ECHA, 2017) Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate (EC 944-336-4) is not considered to meet the screening criterion for bioaccumulation in aquatic species since the log Kow of 3.35 and 3.76 is below the trigger value of 4.5.

However, according to ECHA Guidance R.11 (ECHA, 2017) there is indication that accumulation in air breathing organisms might occur based on the calculated log Koa of > 5 (8.24 - 9.47) in combination with the log Pow > 2. These screening values (Kow and Koa) referred to in the ECHA Guidance R.11 are a function of the modelled organisms, food webs and environments used to obtain these values. To develop this partition coefficient combination it was clearly indicated in the guidance that biomagnification potential is only assumed for substances with high chemical absorption efficiency from the diet, no biotransformation after absorption and negligible active transport (in or out).

The evaluation of the toxicokinetic behavior indicates that the substance will be readily absorbed from the GI tract based on the physical state, log Pow and water solubility, while the molecular weight is likely to be a limiting factor (≥ 442.51 g/mol). However, the test item is predicted to undergo enzymatic hydrolysis in the gastrointestinal tract and absorption of the hydrolysis products rather than (or in addition to) the parent substance is likely. Because the target substance contains ester as well as urethane groups, several hydrolysis products are possible. The absorption rate of the hydrolysis products is expected to be high. Due to the limited information and high complexity on the hydrolysis products of the target substance, as a worst-case approach the oral absorption potential is assumed to be high. Absorption via the inhalation route is assumed to be limited. Also low absorption via the dermal route is expected. The absorbed hydrolysis products are readily distributed throughout the organism, with limited distribution in adipose tissue. The hydrolysis products are expected to be rapidly conjugated and excreted via the urine, or metabolised and excreted via air as CO₂.

Two dermal metabolites and 20 hepatic metabolites were predicted for each of the main components using QSAR OECD toolbox v3.3 (OECD, 2014). The metabolites are mainly the result of hydrolysis of the ester groups and of a hydroxyl group being added to, or substituted with, a methyl group, and furthermore the hydrolysis of the amino group. The hydroxyl groups make the substances more water-soluble and susceptible to metabolism by phase II-enzymes. Up to 99 metabolites were predicted to result from microbiological metabolic pathways (QSAR OECD toolbox, v3.3.0.152, 2014). For further details on the toxicokinetic behavior please refer to the toxicokinetic statement in IUCLID section 7.1.

In conclusion, the trigger values for biomagnification in air-breathing (terrestrial) organisms as stipulated in the ECHA Guidance R.11 are likely to overestimate the potential for biomagnification in the food chain. Even though absorption via oral exposure cannot be excluded the described metabolic and excretion pathways are likely to minimize biomagnification in the food chain.

 

Toxicity Assessment

The available effect concentrations for acute and long-term toxicity to aquatic organisms are > 0.01 mg/L. Furthermore, the substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to the CLP Regulation. Therefore this substance does not meet the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 and it is concluded that the substance is not T.

 

In conclusion, the substance is not PBT/vPvB.