PROCESS OIL

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 417 (Toxicokinetics)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate nr 2011/40 on July 19th 2011

Test material

Test material information

Constituent 1

Reference substance name:

PROCESS OIL

IUPAC Name:

PROCESS OIL

Test material form:

gas under pressure: refrigerated liquefied gas

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

Oral

Main ADME results 2

Type:

absorption

Results:

Dermal

Main ADME results 3

Type:

absorption

Results:

Inhalation

Main ADME results 4

Type:

distribution

Results:

Bioaccumulation

Main ADME results 5

Type:

metabolism

Main ADME results 6

Type:

excretion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Oral:
In the acute oral toxicity study in rats, noclear systemic effects were found up to the highest dose of 2000 mg/kg. The only potential effect of OIL T279 was an equivocal slightly reduced mean weight gain (when compared with historical control data) at 2000 mg/kg, which was probably related to stress.
Dermal:
The assumed high molecular weight of the constituents of OIL T279 would be expected to preclude passage across the skin.
Inhalation:
No inhalative toxicity are available for OIL T279. Based on the physical state, vapour pressure, high molecular weight and boiling point (non volatile liquid), fugacity is expected to be very low. Based on these data, systemic exposure by this route of exposure could be expected to be negligible.

Details on distribution in tissues:

Measured levels of analytes in body fluids (blood, plasma), organs or excreta (urine, faeces) are not available for OIL T279. In any case, it would not be feasible to generate such data for each of the components of OIL T279.
Distribution may be assessed from systemic effects observed in toxicology studies. No conclusions can be drawn on distribution, in view of the lack of any proof of absorption in the available animal studies.
Bioaccumulation:
The lack of any worsening toxicity with continued treatment in the repeated dose studies does not point to any indications of bioaccumulation. This does not,however, preclude the bioaccumulation of non-toxic components of OIL T279 with no physiological conséquences.

Details on excretion:

Experimental excretion data are not available for OIL T279. Some hints about the excretion pattern may be derived from the results of toxicity studies. No noteworthy coloration (urine, faeces), odour or lesions of gastro-intestinal or urinary tracts were noted in any oral or dermal toxicity study. Therefore, no conclusions could be drawn on the route of excretion.

Metabolite characterisation studies

Metabolites identified:

not measured

Any other information on results incl. tables

Metabolism:

. The addition of S9 mix did not have any noticeable effect on the solubilitu of the test item.

. No genotoxicity of OIL T279 was found, with or without S9 mix.

. The addition of S9 mix generall led to decreased cytotoxicity. Therefore, there is a strong indication that liver enzymes are able to metabolize OIL T279 to less cytotoxic metabolites. However, the biological pertinence of this finding very limited in view of the lack of demonstrated systemic exposure following oral or dermal administration.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
No indication of possible bioaccumulation of toxicologically relevant components in the performed toxicity studies.