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Diss Factsheets

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:
Toxicokinetic study with oral administration of the radiolabelled test item and examination of the excretion via urine and feces.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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
Molecular formula:
C20H12N2O2
IUPAC Name:
5,12-dihydroquino[2,3-b]acridine-7,14-dione
Test material form:
not specified
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:
CMC (carboxymethyl cellulose)
Duration and frequency of treatment / exposure:
single exposure with excreta collection up to 72 h post exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
3.22 mg/kg (33.68 uCi/kg) for males, 5.44mg/kg (56.81 uCi/kg) for females
Control animals:
other: not required

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Based on the excretion data there is no oral absorption
Details on excretion:
Recovery of administered radioactive dose was virtually complete: 91.9 +/- 6.9 % of dose males; 100.5 +/-8.7% of dose females. There were no gender related differences in the route of excretion. More than 90 % of the recovered radioactivity was eliminated in the feces and cage washes, which appeared to contain residual fecal matter. At 72 hours virtually all radioactivity had been eliminated by the rats. The urine from both groups of rats contained very low amounts of radioactivity, 0.0089% of dosed males; 0.0020% of dose females.

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 was negligible.
Executive summary:

In this toxicokinetic study, the radiolabelled test item was administered orally per gavage to male and female F-344 rats as a suspension in aqueous 1% carboxymethyl cellulose (3.22 mg/kg (33.68 uCi/kg) for males, 5.44 mg/kg (56.81 uCi/kg) for females). Urine and feces were collected from each rat at 2, 8, 24, 48 and 72 hours after dosing; cage washes and gastrointestinal tract of each rat were removed after euthanasia at 72 hour post-dose. Recovery of administered radioactive dose was virtually complete: 91.9 +/- 6.9 % of dose males; 100.5 +/-8.7% of dose females. There were no gender related differences in the route of excretion. More than 90 % of the recovered radioactivity was eliminated in the feces and cage washes, which appeared to contain residual fecal matter. At 72 hours virtually all radioactivity had been eliminated by the rats. The urine from both groups of rats contained very low amounts of radioactivity, 0.0089% of dosed males; 0.0020% of dose females.