Registration Dossier
Registration Dossier
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EC number: 268-859-6 | CAS number: 68152-93-2
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Absorption: The substance Envamul 600 is a complex mixture of components, addition products of tall oil fatty acids and maleic anhydride. Water solubility of the UVCB substance is limited (376 mg/L at 20 °C). In the subacute oral toxicity study performed with the substance no systemic toxic effects were observed. However, based on the molecular weight (~ 300 Da) and the log Pow (~5) some bioavailability is to be assumed. No adverse effects were observed in the subacute toxicity study (OECD 422) and also no effects on fertility or teratogenicity. An irritating potential was observed in the in vitro skin irritation tests as well as skin sensitisation effects. Based on the physical-chemical properties of Envamul 600 it would be expected that its rate of transfer between the stratum corneum and the lower epidermis and dermis after topical administration is limited [ECHA, Chapter R.7c: Endpoint specific guidance]. In the Local Lymph Node Assay (LLNA) in mice a skin sensitising potential was determined. These effects show that at some absorption of the substance via skin may occur. Systemic availability after dermal exposure is expected to be low (assumed < 10%). Dermal absorption of highly water-soluble substance may occur where the log Pow is between 1 - 4 with log Pow values between 2 and 3 favouring uptake. When log Pow exceeds 4, penetration may be limited by the rate of transfer between the stratum corneum and epidermis although uptake of a substance by the stratum corneum will be high. Based on these criteria, the substance may enter the stratum corneum; however, the possibility for absorption (either by stratum corneum or skin as a whole) is not clear and expected being low compared to gastrointestinal route. Inhalation exposure to maleated tall-oil is unlikely, because it has a very low vapour pressure (0.19 Pa at 20 °C) limiting its availability under a vapour state, and as the substance is a highly viscous liquid its availability to form aerosols is limited too.
Distribution in tissues: There is no indication in the available study results regarding the metabolism or distribution of maleated tall-oil or components thereof.
Excretion: In available studies no indication for specific excretion was observed.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
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