Oligomerisation products of ethylene oxide with reaction products of rape oil and ethanolamine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20/08/2010-26/08/2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Toxikocinetic Statement

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex VIII (point 8.8) of Regulation (EC) No 1907/2006

Deviations:

no

Principles of method if other than guideline:

The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, May 2008).

GLP compliance:

no

Test material

Test material information

Constituent 1

Details on test material:

-Physical state: yellow slightly viscous liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

other: oral route

Vehicle:

not specified

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

The substance is absorved via the gastro-intestinal tract. This is supported by the phisic-chemical properties of the substance; relative low molecular weight and high log octanol/water partition coefficient value may enhance the oral absorption but only to the limited extent due to its low water solubility (290-399.62g/mol, log Pow of 5.57-5.73 and water solubility of 4-9.4mg/L at 20±0.5º)

Details on distribution in tissues:

The subtance is distributed systemically. The low water solubility of the substance may limit the substance to diffuse through channels and pores. If absorbed, the substance is likely to be accumulated in the fatty tissue due to the high log octanol/water partition coefficient valu (log Pow of 5.57-5.73)

Details on excretion:

There is no evidence to indicate the route of excretion of the substance. Proorly water-soluble products are not favourable for urinary excretion but this should not be limited for this substance due to the relatively small molecular weight. Biliary excretion may well be the another significant route of excretion for this substance. Excretion of the substance is the air may be also feaible due to its relatively high vapour pressure. Any test material that is not absorbed will be excreted in the faeces.

Metabolite characterisation studies

Metabolites identified:

no

Details on metabolites:

There is no clear evidence of enhanced metabolism following repeated oral exposure of the substance in rats. The follicular cell hypertrophy observed in the thyroid glans in male rats in the repeated dose study might have indicated an induced hepatic metabolism; however this assumption lacks evidence in the liver. The results of the in vivo genotoxicity studies do not show any evidence that the addition of the metabolic system either enhances or diminishes the activity of the substance.

Any other information on results incl. tables

There is no clear evidence of enhanced metabolism following repeated oral exposure of the substance in rats (Dunster et al., 2003; Marr, 2009). The follicular cell hypertrophy observed in the thyroid glands in male rats in the repeated dose study might have indicated an induced hepatic metabolism (Dunster et al., 2003); however this assumption lacks evidence in the liver. The results of the in vitro genotoxicity studies do not show any evidence that the addition of the metabolic system either enhances or diminishes the

activity of the substance (Durward, 1994; Thompson, 1993).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
The available information showed some evidence that the substance is expected to be absorbed via the gastro-intestinal tract. The substance is anticipated to cause severe local effects due to its irritant nature. There is no significant evidence of enhanced metabolism. There is no evidence of enhanced metabolism. there is no evidence to indicate the route of excretion of the substance but urinary and biliary excretion may well be significant routes for this substance. Any test material that is not absorbed will be excreted in the faeces.

Executive summary:

The available information showed some evidence that the substance is expected to be absorbed via the gastro-intestinal tract. The substance is anticipated to cause severe local effects due to its irritant nature. There is no significant evidence of enhanced

metabolism. There is no evidence to indicate the route of excretion of the substance but urinary and biliary excretion may well be significant routes for this substance. Any test material that is not absorbed will be excreted in the faeces.