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Key value for chemical safety assessment

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Since no toxicokinetic studies are available for Soybean oil, epoxidized, reaction products with methanol the following assessment is based on the available physicochemical properties and results from toxicological studies.

1) Uptake

Oral:

The substance is a multi-constituent UVCB which appears as a yellow liquid at room temperature. The log Pow value is > 4.0 at 23°C and thesubstanceis very poorly soluble in water. The substance’s low water solubility and high Log Pow indicate that the substance could be taken up by the gastro-intestinal tract. Acute toxicity data indicate low toxicity: the oral LD50 > 2000 mg/kg bw in rats. No clinical findings were noted (Henkel 1983). No repeated dose oral toxicity test is available with Soybean oil, epoxidized, reaction products with methanol. Based on the category approach, studies performed with Epoxidized soybean oil (ESBO) and Fatty acids, tall-oil, epoxidized, 2-ethylhexylesters (ETP) are applied. The results of the chronic repeated oral dose toxicity study with ESBO indicate that the substance is taken up by the organisms as (transient) systemic effects were observed e.g lower lactic dehydrogenase activity and increased incidence in cystic endometrium (BIBRA & Hazelton 1986). Furthermore, minimal hepatocellular hypertrophy in animals treated with 1000 mg/kg bw/d ETP was observed (Marburg 2005). This change was considered to represent an adaptive reaction most likely induced by an increased biotransformation of the test article. This suggests some absorption through the GI tract may have taken place.

 

Inhalation:

No experimental data is available concerning the respiratory hazard Soybean oil, epoxidized, reaction products with methanol. No data on the particle size distribution, boiling point or vapour pressure of the test substance are available. The substance is highly hydrophobic and very poorly soluble in water, therefore, if the substance is available for inhalation, the substance would most likely be absorbed by micellular solubilisation. In addition, as systemic effects were observedin the available repeated dose oral toxicity test with Epoxidized soybean oil (ESBO) and Fatty acids, tall-oil, epoxidized, 2-ethylhexylesters (ETP), it is very likely that the compound would also be absorbed if inhaled. Therefore for the DNEL derivation the default as reported in the REACH guidance will be used (100% absorption).

 

Dermal:

The log Pow of > 4 and the low water solubility suggest that the substance may easily be taken up by thestratum corneum but the rate of transfer between stratum corneum and the epidermis will limit the uptake of the substance by the organism. This is further substantiated by the lack of systemic effects observed in the acute dermal toxicity study performed with the test substance (Bioassay, 2013). The substance has been identified as not skin sensitizing (FREY-TOX 2013). This strengthening the suggestion that dermal uptake of the test substance will be low. As both oral and dermal absorption are expected to be low a default factor of 1 for oral-to-dermal extrapolation is used for DNEL derivation.

2) Distribution, metabolism, excretion

 

No experimental data is available concerning the distribution, metabolism and excretion of Soybean oil, epoxidized, reaction products with methanol. The repeated dose oral toxicity studies performed with Epoxidized soybean oil (ESBO) and Fatty acids, tall-oil, epoxidized,2-ethylhexylesters (ETP) are several systemic effects were observed. In a embyotoxicity/teratogenicity study according to OECD 414 (Savary, 1993) with ESBO, no effects were observed on fetal development suggesting limited to no passage of the placental barrier by the test item. In addition, in a one generation study according to OECD 415 (Savary, 1993) performed with ESBO, no developmental effects were seen pups suggesting that the test transfer dam to pup via lactation is limited. Its log Pow of > 4 and its low water solubility would suggest distribution into cells and the intracellular concentration may thus be higher than the extracellular concentration particularly in fatty tissues.