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Toxicological information

Basic toxicokinetics

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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.