reaction product of: saturated, monounsaturated and multiple unsaturated long-chained partly estrified alcohols of vegetable origin (Brassica napus L., Brassica rapa L., Helianthus annuus L., Glycine hispida, Gossypium hirsutum L., Cocos nucifera L., Elaeis guineensis) with O,O-diisobutyldithiophosphate and 2-ethylhexylamine and hydrogen peroxide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Expert statement

Adequacy of study:

key study

Study period:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The toxicokinetic assessment was derived from available physiochemical and toxicity data, not based on actual experimental examinations..

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

Principles of method if other than guideline:

Toxicokinetic assessment was performed based on physicochemical properties and available toxicity data

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-630-5

EC Name:

-

Molecular formula:

Not applicable

IUPAC Name:

reaction product of Z-9-octadecen-1-ol and O,O-diisobutyl hydrogen dithiophosphate

Details on test material:

- Name of test material (as cited in study report): Becrosan 6920

Test animals

Species:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Strain:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Sex:

not specified

Administration / exposure

Route of administration:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Vehicle:

unchanged (no vehicle)

Duration and frequency of treatment / exposure:

Not Applicable

Doses / concentrations

Remarks:

Doses / Concentrations:
Not Applicable

No. of animals per sex per dose / concentration:

Not Applicable

Control animals:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Positive control reference chemical:

Not applicable

Details on study design:

Not applicable

Details on dosing and sampling:

Not applicable

Statistics:

Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Results and discussion

Preliminary studies:

Not Applicable

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Not Applicable

Details on distribution in tissues:

Not Applicable

Transfer into organs

Transfer type:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Observation:

not determined

Details on excretion:

Not Applicable

Toxicokinetic parameters

Toxicokinetic parameters:

other: Prediction toxicokinetic behavior based on physicochemical properties and available toxicity data.

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

Not Applicable

Any other information on results incl. tables

Assessment of Toxicokinetics of Becrosan 6920

The assessment of the toxicokinetical behaviour of the test substance Becrosan 6920is based on the information of its chemical-physical properties andofthe results of acute and subacute toxicity studies.

Becrosan 6920is a mixture of lipophilic compounds whereby a Thio-phosphorus ester is the main constituent. After oral administration a good enteral absorption through the stomach and the intestine and a fast distribution is probably. Organophosphorus ester are quickly metabolised in dependence on their reactivity with ester splitting enzyrns accompanied by a decreased toxicity for mammals. After single oral or dermal administration of doses of 2000mg/kg body weight no acute or delayed toxicity signs were recorded in rats. This shows a relatively quickly absorption and excretion without systemic toxic effects. The repeated administration of doses up to1000 mg/kg body weight over 28 days in rats has given no evidence of cumulation, plasma protein binding or enzyrn induction.Theliver can be considered as the most important target organ in mammals. The activity of aspartate aminotransferase of serum was dose-dependent decreased corresponding with a slight decrease of liver weights. This is an expression of toxic effects. The liver is the site of metabolismus of the test substance possibly via a first pass effect with presystemic elimination. Other target organs seem to be the kidneys which relative weights were decreased in male rats. Histopathological findings have given no evidence of binding of the test substance to tissue sites. Therefore a relatively quickly elimination of test substance and/or its metabolites with urine and faeces is assumed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: predicted no bioaccumulation.
Based on the representative chemical structure and available physicochemical property and toxicity data, a prediction of toxicokinetic behavior was created, and absorption, distribution to distance organs, possible metabolism and excretion process were involved.

Executive summary:

Assessment of Toxicokinetics of Becrosan 6920

The assessment of the toxicokinetical behaviour of the test substance Becrosan 6920 is based on the information of its chemical-physical properties andofthe results of acute and subacute toxicity studies.

Becrosan 6920 is a mixture of lipophilic compounds whereby a Thio-phosphorus ester is the main constituent. After oral administration a good enteral absorption through the stomach and the intestine and a fast distribution is probably. Organophosphorus ester are quickly metabolised in dependence on their reactivity with ester splitting enzyrns accompanied by a decreased toxicity for mammals. After single oral or dermal administration of doses of 2000mg/kg body weight no acute or delayed toxicity signs were recorded in rats. This shows a relatively quickly absorption and excretion without systemic toxic effects. The repeated administration of doses up to1000 mg/kg body weight over 28 days in rats has given no evidence of cumulation, plasma protein binding or enzyrn induction.Theliver can be considered as the most important target organ in mammals. The activity of aspartate aminotransferase of serum was dose-dependent decreased corresponding with a slight decrease of liver weights. This is an expression of toxic effects. The liver is the site of metabolismus of the test substance possibly via a first pass effect with presystemic elimination. Other target organs seem to be the kidneys which relative weights were decreased in male rats. Histopathological findings have given no evidence of binding of the test substance to tissue sites. Therefore a relatively quickly elimination of test substance and/or its metabolites with urine and faeces is assumed.