2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics in vivo

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed based on available data on the substance and its constituents.

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment was performed based on available data on the substance and its constituents.

GLP compliance:

no

Type:

absorption

Results:

There is no data available on the registered substance. Following an exposure via the oral route it is expected to dissociate into its constituents. Dermal and inhalation routes are not considered relevant.

Type:

distribution

Results:

There is no data available on the registered substance. Its constituents are expected to be well-dsitributed in a mammalian body.

Type:

metabolism

Results:

There is no data available on the registered substance. The metabolisation process of its constituents is well-known.

Type:

excretion

Results:

There is no data available on the registered substance. Its constituents will be eliminated through respiration and urine respectively.

Details on absorption:

- Oral exposure: There is no data available on the substance following an oral exposure. It is expected that following an exposure to the substance via the oral route, it will dissociate into its constituents 2-ethylhexanoic acid and 2-aminoethanol. Available data on these constituents indicate that they will be absorbed in the gastrointestinal tract.

- Inhalation exposure: There is no data available on the substance following an inhalation exposure, which is not considered as a relevant route of exposure taking into account the uses of the substance.

- Dermal exposure: There is no data available on the substance following a dermal exposure, which is not considered as a relevant route of exposure taking into account the uses of the substance.

Details on distribution in tissues:

There is no data available on the substance following an exposure via the oral, inhalation or dermal routes. Absorption of its constituents is expected to occur following an oral exposure. Both are hydrophilic compounds expected to be well-distributed in the body and unlikely to accumulate.

Details on excretion:

There is no data available on the substance following an exposure via the oral, inhalation or dermal routes. Respiration was identified as the main elimination route for 2-aminoethanol and urine for 2-ethylhexanoic acid.

Metabolites identified:

not specified

Details on metabolites:

There is no data available on the substance following an exposure via the oral, inhalation or dermal routes. 2-aminoethanol is expected to be metabolised exhaled CO2, glycine, serine, choline, urea and uric acid while 2-ethylhexanoic acid will be metabolised into glucuronide-2-ethylhexanoic acid, glucuronide-diacid and hydroxylated 2-ethylhexanoic acid.

Conclusions:

An assessment was performed based on available data on the substance and its constituents.

Executive summary:

The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of 2-ethylhexanoic acid, compound with 2-aminoethanol.

It is expected that the individual constituents of the substance will behave independently following exposure via the oral route. Therefore the toxicokinetics behaviour of 2-ethylhexanoic acid, compound with 2-aminoethanol is expected to be driven by the toxicokinetics behaviour of 2-aminoethanol and 2-ethylhexanoic acid.

It is expected that 2-aminoethanol and 2-ethylhexanoic acid will be well absorbed and distributed following an exposure by the oral route. However, available animal data on the substance do not allow confirmation that absorption occurs following an oral exposure to 2-ethylhexanoic acid, compound with 2-aminoethanol. Based on the uses of the substance no exposure via inhalation or the dermal route of 2-ethylhexanoic acid, compound with 2-aminoethanol is expected.

Metabolisation is expected for both 2-ethylhexanoic acid and 2-aminoethanol with an elimination occurring mainly through urine and respiration respectively.

It is not considered justified to perform animal studies on this substance to further investigate its toxicokinetics behaviour.

Description of key information

The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of 2-ethylhexanoic acid, compound with 2-aminoethanol.

It is expected that the individual constituents of the substance will behave independently following exposure via the oral route. Therefore the toxicokinetics behaviour of 2-ethylhexanoic acid, compound with 2-aminoethanol is expected to be driven by the toxicokinetics behaviour of 2-aminoethanol and 2-ethylhexanoic acid.

It is expected that 2-aminoethanol and 2-ethylhexanoic acid will be well absorbed and distributed following an exposure by the oral route. However, available animal data on the substance do not allow confirmation that absorption occurs following an oral exposure to 2-ethylhexanoic acid, compound with 2-aminoethanol. Based on the uses of the substance no exposure via inhalation or the dermal route of 2-ethylhexanoic acid, compound with 2-aminoethanol is expected.

Metabolisation is expected for both 2-ethylhexanoic acid and 2-aminoethanol with an elimination occurring mainly through urine and respiration respectively.

It is not considered justified to perform animal studies on this substance to further investigate its toxicokinetics behaviour.