Reaction mass of 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] and 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide] and 2-[[3,3'-dichloro-4'-[[1-[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-3-oxo-N-(o-tolyl)butyramide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Objective of study:

other: bioavailability of hypothetical cleavage products

Principles of method if other than guideline:

investigation of urinary excretion of a hypothetical cleavage product of the test item after oral application

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-[[2-chloro-4-[3-chloro-4-[[1-(2,4-dimethylphenylamino)-1,3-dioxobutan- 2-yl]diazenyl]phenyl]phenyl]diazenyl]-N-(2-methylphenyl)-3-oxobutanamide

EC Number:

911-715-0

Molecular formula:

C36H34Cl2N6O4 // C35H32Cl2N6O4 // C34H30Cl2N6O4

IUPAC Name:

2-[[2-chloro-4-[3-chloro-4-[[1-(2,4-dimethylphenylamino)-1,3-dioxobutan- 2-yl]diazenyl]phenyl]phenyl]diazenyl]-N-(2-methylphenyl)-3-oxobutanamide

Constituent 2

Reference substance name:

Pigment Yellow 174

IUPAC Name:

Pigment Yellow 174

Radiolabelling:

no

Test animals

Species:

rat

Strain:

other: Tif:RAI f (SPF)

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: oil (no further information)

Duration and frequency of treatment / exposure:

single exposure

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 40, 400 mg/kg

No. of animals per sex per dose / concentration:

The test was performed with 30 male rats, not indicated how many animals were investigated per substance and dose group

Control animals:

yes

Positive control reference chemical:

3,3'-dichlorobenzidine

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:

- No 3,3'-dichlorobenzidine metabolites were detected in the urine collected after administration of the test item.

Any other information on results incl. tables

- animals receiving 3,3'-dichlorobenzidine excreted 2-4% of the administered dose within 24 hours and additional 0.2-1% between 24 and 48 hours after application

- limit of detection: 5 µg/l urine

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: no indication for a metabolic spllitting of the pigment into 3,3'-dichlorobenzidine
No 3,3'-dichlorobenzidine was detectable in the urine of rats after oral application, which indicates that the test item is not splitted into 3,3'-dichlorobenzidine after oral application.

Executive summary:

Single oral application of 40 or 400 mg test item/kg bw to male rats did not result in the excretion of 3,3'-dichlorobenzidine in the urine during 48 hours after exposure. After application of 3,3'-dichlorobenzidine about 2 -4% of the applied dose was detected in the urine excreted within 24 hours after application.