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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
review article or handbook
Title:
Toxicology and Carcinogenesis Studies of C.I. Pigment Red 23 (CAS No. 6471-49-4) in F344 Rats and B6C3F1 Mice (Feed Studies)
Author:
NTP
Year:
1992
Bibliographic source:
NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, November 1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells.
GLP compliance:
not specified
Type of assay:
other: chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
EC Number:
229-313-2
EC Name:
3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
Cas Number:
6471-49-4
Molecular formula:
C24H17N5O7
IUPAC Name:
3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Common name : 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide, C.I. Pigment Red 23
- Molecular formula : C24H17N5O7
- Molecular weight : 487.4263 g/mol
- Smiles notation : c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1)[N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
- InChl : 1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
- Substance type : Organic
- Physical state : Solid
Specific details on test material used for the study:
- Name of test material : 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Common name : 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide, C.I. Pigment Red 23
- Molecular formula : C24H17N5O7
- Molecular weight : 487.4263 g/mol
- Smiles notation : c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1)[N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
- InChl : 1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
- Substance type : Organic
- Physical state : Solid
-Purity->96 %

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
Not specified
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced male Sprague-Dawley rats
Test concentrations with justification for top dose:
0,30, 50, 100 µg/ml
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
cyclophosphamide
mitomycin C
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: No data available
- Exposure duration:
Without metabolic activation- 15 hour
With metabolic activation- 2 hour

- Expression time (cells in growth medium): Without metabolic activation- 15 hour
With metabolic activation- 13 hour

SPINDLE INHIBITOR (cytogenetic assays): Colcemid

STAIN (for cytogenetic assays):stained with Giemsa


OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:

Evaluation criteria:
Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). were observed .
Statistics:
Not applicable.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
The pigment C.I. Pigment Red 23 was negative for the induction of chromosomal aberrations in Chinese hamster ovary cells both in the presence and absence of S9.
Executive summary:

The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells.In the Abs test without S9, cells were incubated in McCoy's 5A medium with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 for 10-h Colcemid was added and incubation continued for 2 to 3 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa.For the Abs test with S9, cells were treated with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 11 hours in fresh medium, with Colcemid present for the final 2 hours. No induction of chromosome aberration was observed in Chinese hamster ovary cell in presence and absence of metabolic activation.