Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Structural assessment

The substance is a complex UVCB which contains a variety of esters (C32-48), alcohols (C18-24), ethers (C34-48) and paraffins (C28-30).

 

Different components and functional groups within this substance could undergo a variety of Phase I metabolism reactions, for example oxidation of alcohol groups to aldehydes and/or carboxylic acids, followed by Phase II conjugation reactions. The ester components might also undergo some degree of hydrolysis to the corresponding carboxylic acid and alcohol moieties.

 

The Molecular Weight of the component substances would indicate that some degree of absorption is possible. Furthermore any hydrolysis of the ester components will create lower MW species which would be more easily absorbed.

 

Phys-chem

The substance is very poorly soluble in water (<1 mg/l). The Log Pow is high (>6.5). The low water solubility and high lipophilicity means the substance is likely to be poorly absorbed.

 

Toxicology

In an acute oral study dosed at 2000 mg/kg, clinical signs were seen in one of 5 animals. In addition in an acute dermal study dosed at 2000 mg/kg, slight body weight loss was seen in two of 5 animals during week 1 after dosing, but the animals then gained weight during week 2. These were the only signs of toxicity seen in any of the available toxicology studies. In both acute studies no target organ(s) were identified. No signs of toxicity were seen following repeated dosing at 1000mg/kg in 28 day sub-acute and developmental toxicity studies. The limited signs of toxicity seen in some animals provides limited evidence of some absorption at the very highest dose however there is no evidence of absorption following repeated dosing at only slightly lower doses.

 

Conclusion

Limited toxicokinetic conclusions can be made on the basis of the available dataset. However from the available structural data, phys-chem properties and toxicology data,  it is likely that the substance is very poorly absorbed.