Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
cytotoxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed under GLP, no OECD guideline applicable

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988
Reference Type:
other:
Title:
Final toxicology review of carbazole violet (CI Pigment Violet 23) for use as a colorant in contact lenses
Author:
Additives Evaluation Branch (HFF-158), Division of Food and Color Additives, Center for Food Safety and Applied Nutrition, Department of Health and Human Services
Report date:
1988

Materials and methods

Principles of method if other than guideline:
In vitro cytotoxicity on monolayer of L-929 mouse fibroblast cells
GLP compliance:
yes
Type of method:
in vitro
Endpoint addressed:
skin irritation / corrosion
eye irritation

Test material

Constituent 1
Chemical structure
Reference substance name:
2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene
EC Number:
606-790-9
Cas Number:
215247-95-3
Molecular formula:
C34H22Cl2N4O2
IUPAC Name:
2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene
Test material form:
solid: particulate/powder

Administration / exposure

Route of administration:
other: in vitro exposure of cell line via the culture medium
Vehicle:
other: MEM cell culture medium
Duration of treatment / exposure:
24 hours
Frequency of treatment:
one treatment
Post exposure period:
not relevant
Doses / concentrations
Remarks:
Doses / Concentrations:
0.1 g in 2 ml MEM cell culture medium
Basis:
nominal conc.
Details on study design:
A confluent monolayer of L-929 Mouse Fibroblast cells was used. Monolayers were washed with Calcium and Magnesium Free Phosphate buffered saline and 2 ml of 5% MEM (without neutral red) and the test sample (0.1 g ) and controls (amount not given) were added to the cultures.
Test Materials:
- Carbazole Violet (neat powder) Pigment,
- USP Negative Control Plastic
- Positive Control latex, P-11102*

Examinations

Examinations:
After a 24 hour incubation at 37 C the cultures were observed microscopically for cell lysis. Observations were scored as nontoxic, no change in cell
morphology, or toxic, death and degeneration of cells observed (no zones of lysis measured).

Results and discussion

Details on results:
A single culture exposed to 0.1 g of carbazole violet and a single negative control culture were scored as nontoxic.
The positive control was scored as toxic, cells around the control material were lysed.

Applicant's summary and conclusion

Conclusions:
In a in vitro cytotoxicity study, Carbazole violet (Pigment Violet 23) at a concentration of 50 mg/ml was not cytotoxic to cultured mammalian cells (L929 mouse fibroblasts) when incubated for 24 hours.
Executive summary:

In a in vitro cytotoxicity study, Carbazole violet (Pigment Violet 23) at a concentration of 50 mg/ml was not cytotoxic to cultured mammalian cells (L929 mouse fibroblasts) when incubated for 24 hours.

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