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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on measurements made for physical chemistry properties and  qualitative observations for systemic toxicology, the test substance is considered to have only a low potential for absorption and bioaccumulation.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

The low water solubility of the substance (0.0476 mg/l), its relatively high molecular weight (414.49) and moderate water/octanol partition coefficient (Log Kow 2.78-3.5) indicates that, on balance, the test substance has a potential for low bioavailability. 

The low potential for absorption via the gastro-intestinal tract is supported by the mild systemic effects apparent at high dosages in sub-acute and sub-chronic oral toxicity studies in rats.(Section 5.6.3) and the complete absence of effects following acute oral exposure (Section 5.2.3). A limited uptake via the lymphatic system cannot be excluded. 

The test substance is a dimethyl benzylidene derivative of sorbitol, .The four ether bonds would be expected to be relatively stable, so the primary metabolic pathway would probably be via the oxidation of the sorbitol carbon chain to give diols, dicarboxylic acids or a combination of the two. . The residual benzylidine moiety, alcohols and carboxylic acids could be conjugated with glucuronic acid to give hydrophilic metabolites that would be readily excreted. None of the metabolites formed by these processes would be considered to have any genotoxic potential. 

There is no toxicological evidence of distribution to the central nervous system, but the moderate water/octanol partition coefficient would indicate slight potential for tissue accumulation.  

The absence of systemic effects following acute dermal exposure to the test material (Section 5.2.3) indicates that no significant absorption occurs through the skin, and the very low vapour pressure and modest particle size (median diameter 14µm) suggests that the air concentration of the substance available for absorption via the lungs would be low.