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Description of key information

Key value for chemical safety assessment

Additional information

TOXICOKINETIC BEHAVIOUR

 

Physico-chemical properties:

2-ethylhexanoic acid, monoester with propane-1,2-diol (FX511) is a clear colourless liquid at room temperature and pressure and the molecular weight is 202.3 g/mol. The mean measured Log P (octanol-water) is 2.98 at 40 degC and the water solubility has been determined as 1.79 g/L at 20 degC. The vapour pressure value is 1.2 Pa at 25 degC which is indicative that the substance is not volatile at room temperature and pressure, therefore inhalation exposures are not a concern.

 

Absorption:

There are no directly measured ADME data by any route for FX511.

 

Oral: In the key study for acute oral toxicity (Snell, 1995), some minor clinical signs were present during the first day after a single 2000 mg/kg bw dose was administered unchanged and by oral gavage, suggesting the material had absorbed rapidly into the body. The animals appeared normal after 1 day, which may be indicative that the absorbed material is rapidly metabolised, cleared and excreted. There are no repeat dose studies for this material.

 

Inhalation: no data, as the substance is not volatile and not expected to be inhaled.

 

Dermal: FX511 is not a skin irritant. It is not a skin sensitiser. 

In the key study for acute dermal toxicity (Sanders, 2012), there are no reported systemic effects and no mortality when the substance was dosed neat up to 2000 mg/kg. It is not possible from the data to ascertain whether or not the substance absorbed across the skin and into systemic circulation.

 

Distribution:

There are no specific data on differential distribution to organs.

 

Metabolism:

There is no information on metabolism of this substance in the body.

 

FX511 is likely to undergo some degree of hydrolysis by esterases, particularly under acidic conditions to form 2-ethylhexanoic acid and propan-1,2-diol.

 

There is no evidence from in vitro genotoxicity studies to suggest that metabolism plays a role in the genotoxic properties of this substance. FX511 is non genotoxic in the absence and presence of metabolic activation.

 

Excretion:

No data are available to determine the pathways or extent of excretion.