Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, acetates

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1971

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Objective of study:

excretion

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides

EC Number:

295-835-2

EC Name:

Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides

Cas Number:

92129-33-4

Molecular formula:

R2N+(CH3)2, Cl- with R is fatty alkyl with chainlengths C16-C18 (even numbered)

IUPAC Name:

N-C16-C18(even numbered)-alkyl-N,N-dimethyl-C16-C18(even numbered)-alkyl-1-aminium chloride

Details on test material:

Dimethyldihydrogenated tallow ammonium chloride manufactured by the Armour Industrial Chemical Company.

Radiolabelling:

no

Test animals

Species:

rat

Strain:

other: Charles River albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

Charles River albino rats, obtained from Charles River Breeding Laboratories, Massachusettes. Rats were fed ad libitum. They were housed individually in standard wire-bottomed steel cages.

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Duration and frequency of treatment / exposure:

91 days, provided daily in the diet. The parents of these rats were also exposed for approximately 4 weeks prior to mating.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

7 ppm

Doses / concentrations 2

Dose / conc.:

140 ppm

Doses / concentrations 3

Dose / conc.:

2 800 ppm

No. of animals per sex per dose / concentration:

3 males and 3 females per dose

Control animals:

yes, plain diet

Positive control reference chemical:

Not examined

Details on study design:

A 90 day feeding study was conducted at Industrial BIO-TEST laboratories with groups of rats who were the offspring of previously exposed rats. At the end of the 90 day feeding study, some of the rat s were maintained on the diet for an extra 24 hours and housed in metabolism cages for the collection of urine and faeces. Average dose levels per day were calculated based on body weights and individual feed consumption during the last six weeks of the feeding study.

Details on dosing and sampling:

24 hour urine and faeces were collected and frozen separately. The samples were analysed for quarternary compound content at Armour Industrial Chemical Company Laboratories. Samples were extracted with chloroform prior to colorimetry analysis.

Statistics:

None reported

Results and discussion

Preliminary studies:

Not applicable

Main ADME results

Type:

excretion

Results:

The authors concluded that significant amounts of the compound were metabolised by the rats.

Toxicokinetic / pharmacokinetic studies

Details on excretion:

Very little test substance was found in the urine from the highest feeding level. Tests on the lower feeding levels were negative within experimental error. It was necessary to develop a background correction factor for the faecal analysis because each
control sample exhibited a different background value. An average of 13% was eliminated in the faeces from the high dose group.

Any other information on results incl. tables

 

Test substance excretion data from rats fed 2800 ppm
Animal No. and Sex	Average Intake (mg)	Amount Recovered (mg)	% Recovered
1M	64.7	5.7	8.8
2M		22.8	35.3
3M		2.2	3.4
Average			15.8
4F	51.0	6.1	11.9
5F		0.5	0.9
6F		2.6	5.0
Average			5.9

 

At lower dietary levels (7 and 140 ppm) virtually no quarternary compound was recovered. At the higher dietary level (2800 ppm) an average of 15% was excreted by males and 5.9% by females, with the majority of excreted compound being found in the faeces. The authors concluded that significant amounts of the compound were metabolised by the rats.

Applicant's summary and conclusion

Conclusions:

The authors concluded that significant amounts of the compound were metabolised by the rats.

Executive summary:

Albino rats were fed with the test substance in the diet as part of a separate 90-day feeding study. At the end of the study they were maintained on the diet for a further 24 hours for collection of urine and faeces in metabolism cages. The excretion of the quarternary compound in the urine and faeces was determined by colorimetry following chloroform extraction.

At lower dietary levels (7 and 140 ppm) virtually no quarternary compound was recovered.

At the higher dietary level (2800 ppm) an average of 15% was excreted by males and 5.9% by females, with the majority of excreted compound being found in the faeces. The authors concluded that significant amounts of the compound were metabolised.