Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

year of study report: 1991

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: secondary source, original study report not available

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Reference 2

Reference Type:

review article or handbook

Title:

High Production Volume (HPV) Challenge Program Test Plan for C.I. Pigment Violet 19 (CAS NO.: 1047-16-1) and C.I. Pigment Red 122 (CAS NO. 980-26-7) and Dihydro Quinacridone (CAS NO. 5862-38-4)

Author:

CPMA, Color Pigments Manufacturers Association, Inc. Quinacridone Committee

Year:

2006

Bibliographic source:

http://www.epa.gov/HPV/pubs/summaries/ci19122d/c16303tc.htm

Report date:

2006

Materials and methods

Objective of study:

toxicokinetics

Principles of method if other than guideline:

Tissue distribution of radioactivity was determined by whole body autoradiography at selected time points up to 48 hours after dosing of rats.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

213-879-2

EC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Cas Number:

1047-16-1

IUPAC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Details on test material:

- Name of test material (as cited in study report): C.I. Pigment Violet 19 (CAS NO.: 1047-16-1), QV19

Radiolabelling:

yes

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Duration and frequency of treatment / exposure:

single exposure and analysis of tissue distribution by autoradiography up to 48 h post exposure

No. of animals per sex per dose / concentration:

not stated

Control animals:

other: not required

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Based on the distribution data there is no absorption by the oral route.

Details on distribution in tissues:

The autoradiogram showed that radioactivity was localized only in the gastrointestinal tract of both male and female rats. No radioactivity was detected in other organs and tissues of the animals. The highest concentrations of radioactivity were found at 2 hours post dosing . Most of the radioactivity was eliminated from the rats at 24 hours and it was virtually undetected at 18 hours post-dose (according to the authors).

Details on excretion:

- "Most of the radioactivity was eliminated from the rats at 24 hours and it was virtually undetected at 18 hours post-dose."
- excretion seems to be via faeces

Metabolite characterisation studies

Metabolites identified:

not measured

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Under the conditons of this study, the systemic absorption of the test item (Pigment Violet 19) was negligible.

Executive summary:

In this toxicokinetic study, the radiolabelled test item (Pigment Violet 19) was administered orally to groups of male and female Fisher 344 rats by gavage. The tissue distribution of radioactivity was determined by whole body autoradiography at selected times up to 48 hours after dosing. The autoradiogram showed that radioactivity was localized only in the gastrointestinal tract of both male and female rats. No radioactivity was detected in other organs and tissues of the animals. The highest concentrations of radioactivity were found at 2 hours post dosing . Most of the radioactivity was eliminated from the rats at 24 hours and it was virtually undetected at 18 hours post-dose.