Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment based on available information
Adequacy of study:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on available information

Data source

Reference
Reference Type:
other: Statement
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Objective of study:
other: toxicokinetic assessment
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A toxicokinetic assessment has been performed based on physical chemical properties of the substance and available open literature.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS: 22174-70-5

Administration / exposure

Route of administration:
other: oral, dermal, inhalation

Results and discussion

Any other information on results incl. tables

A toxicokinetic assessment has been performed based on physical chemical properties of the substance and available open literature.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Based on available data, dermal, oral and inhalation absorptions are set to 100%
Based on the available data, oral, dermal and inhalation potenial are set to 100% for risk assessment.
Whereas log Kow is > 4, the calculated BCF remains < 2000, suggesting that 2 -ethylhexylal has NO BIOACCUMULATIVE potential.
Executive summary:

ABSORPTION

The calculated partition coefficient of 2-ethylhexylal is 6.53, meaning that the substance is lipophilic with a water solubility < 1 mg/L. This property of the substance is favourable for absorption.

- Oral/GI absorption

Low molecular weight of the substance is favourable for absorption. However, absorption of very hydrophilic substances by passive diffusion may be limited.

For risk assessment purposes, the oral absorption is set at 100%. The results of the toxicity studies do not provide reason to deviate from this proposed oral absorption.

 

- Respiratory absorption-inhalation

With a vapor pressure <0.01 kPa, 2 -ethylhexylal shows a low volatility. As a highly lipophilic substance, it would be poorly absorbed.

For risk assessment purposes, the inhalation absorption is set at 100%. The results of the toxicity studies do not provide reason to deviate from this proposed oral absorption.

- Dermal absorption

Dermal uptake is likely to be low with a WS < 1 mg/L. At more, with a log Kow above 6, uptake into the stratum corneum may be slow. The criteria for 10% dermal absorption as given in the TGD (3) (MW > 500 and log Pow < -1 or > 4) are not met, and hence a dermal absorption of 100% is proposed for risk assessment purposes.

DISTRIBUTION

Once absorbed, widely distribution of 2 -ethylhexylal in the body is expected based on its low molecular weight.

This lipophilic substance is likely to distribute into cells.

Accumulative potential

Whereas log Kow is > 4, the calculated BCF remains < 2000, suggesting that 2 -ethylhexylal has NO BIOACCUMULATIVE potential.

METABOLISM and EXCRETION

Based on the available data, no additional conclusions can be drawn on the metabolism and excretion of 2 -ethylhexylal after dermal and inhalatory absorption.