Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Based on the available data on the test material sodium glucoheptonate, a screening assessment has been conducted by a qualified toxicologist. The screening assessment looks into adsorption, distribution, metabolism and excretion.
The following conclusions were made by the toxicologist:
The available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin. Once absorbed, the substance would be distributed in the serum and urine is the significant route of excretion. There is no evidence suggesting that the test substance may be metabolised, however no studies have been conducted to identify metabolites.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Absorption:

Although the test item is lipophobic in nature the high water solubility (55.8-58.1% at 20°C + 0.5°C; Butler, 2013) and small molecular size of the substance could allow absorption through passive diffusion. This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood.

Limited absorption may also take place via the skin due to small molecular size and water solubility.

The low vapour pressure value (3.5 x 10-5 Pa at 25°C; Tarran, 2013 b) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.

Distribution:

Once absorbed, the substance may be distributed in serum due to the water solubility and may therefore be distributed systemically. The lack of evidence to suggest the test item is a sensitizer suggests that it does not bind to circulatory proteins. The high water solubility and low log octanol/water partition coefficient value would also suggest that the test item does not accumulate in body fat.

Metabolism:

The results of the repeated dose reproductive screening study did not show evidence to indicate any test item influenced hepatic metabolism (McRae, 2013). The results of the genotoxicity assays have shown no evidence that genotoxicity is either enhanced or diminished in the presence of the S9 metabolising system (Thompson, 2012; Morris, 2013).

Excretion:

There is no evidence to indicate the route of excretion but high water-soluble products are not favourable for biliary excretion and therefore urinary excretion may well be a significant route for this material. Any test item that is not absorbed will be excreted in the faeces.

Conclusion:

The available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin. Once absorbed, the substance would be distributed in the serum and urine is the significant route of excretion. There is no evidence suggesting that the test substance may be metabolised, however no studies have been conducted to identify metabolites.