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EC number: 242-355-6 | CAS number: 18472-87-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- secondary source
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING -ACID RED 92, COLIPA n° C53
- Author:
- SCCNFP
- Year:
- 2 004
- Bibliographic source:
- COLIPA n° C53 , SCCNFP/0788/04, 23 April 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- In vivo Mammalian Erythrocyte Micronucleus Test of Acid Red 92 in NMRI mouse was conducted.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- EC Number:
- 242-355-6
- EC Name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- Cas Number:
- 18472-87-2
- Molecular formula:
- C20H4Br4Cl4O5.2Na
- IUPAC Name:
- Sodium 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- IUPAC name: 3,4,5,6-Tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
Molecular weight: 829.6388
Molecular formula: C20-H2-Br4-Cl4-O5.2Na
Smiles: [Na+].[Na+].[O-]c1c(Br)cc2c(Oc3c(Br)c([O-])c(Br)cc3C24OC(=O)c5c(Cl)c(Cl)c(Cl)c(Cl)c45)c1Br
Inchl: InChI=1S/C20H4Br4Cl4O5.2Na/c21-5-1-3-17(9(23)15(5)29)32-18-4(2-6(22)16(30)10(18)24)20(3)8-7(19(31)33-20)11(25)13(27)14(28)12(8)26;;/h1-2,29-30H;;/q;2*+1/p-2
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Fuchsia Red WR 802177
- Molecular formula: C20H2Br4Cl4O5Na2
- Molecular weight: 829. 6398 g/mol
- Substance type: Organic
- Physical state: Red powder
- Purity: 99.5 area % (HPLC), 85 % (w/w) (NMR, calculated as sodium salt).
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- No data available.
- Details on exposure:
- No data available
- Duration of treatment / exposure:
- Exp.1-
24 hrs- 25, 50, 100 mg/kg
48 hrs-100 mg/kg
Exp.2-100 mg/kg
Exp.3- 200 mg/kg
Exp.4-150 mg/kg
Doses / concentrations
- Remarks:
- Doses / Concentrations:Exp.1- 24 hrs- 25, 50, 100 mg/kg 48 hrs-100 mg/kg Exp.3- 200 mg/kg Exp.4-150 mg/kg Basis:
- No. of animals per sex per dose:
- Total 24 animals-12 male and 12 female
Exp.1-25 mg/kg: 2male and 2 female
50 mg/kg: 2male and 2 female
100 mg/kg: 2male and 2 female
Exp.2-100 mg/kg: 2male and 2 female
Exp.3- 200 mg/kg: 2male and 2 female
Exp.4- 150 mg/kg: 2male and 2 female - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive controls: Cyclophosphamide
- Justification for choice of positive control(s): No data available
- Route of administration: No data available
- Doses / concentrations: No data available
Examinations
- Tissues and cell types examined:
- Micronucleates (MN) produced in the polychromatic erythrocytes were observed
- Details of tissue and slide preparation:
- No data available
- Evaluation criteria:
- Frequency of MN was noted
- Statistics:
- No data available
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: No data available
- Solubility: No data available
- Clinical signs of toxicity in test animals: No data available
- Evidence of cytotoxicity in tissue analyzed: No data available
- Rationale for exposure: No data available
- Harvest times: No data available
- High dose with and without activation: No data available
- Other: No data available
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data available
- Induction of micronuclei (for Micronucleus assay): In the treated animals with 100 mg/kg a percentage of MN 0.150 (24h) and 0.110 (48h) was observed: these values, although higher than the control, had a p > 0.34. reduction of PCE was observed, thus indicating a cytotoxic effect of the test item in the bone marrow cells.
- Ratio of PCE/NCE (for Micronucleus assay): No data available
- Appropriateness of dose levels and route: No data available
- Statistical evaluation: No data available
Applicant's summary and conclusion
- Conclusions:
- The substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS Number: 18472-87-2) is non mutagenic in the In vivo Mammalian Erythrocyte Micronucleus Test performed.
- Executive summary:
Genetic toxicity in vivo study was performed for the test chemical3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS Number: 18472-87-2) on male and female NMRI mice. Acid red 92 was injected intraperitoneally in mice and the number of micronucleus formed in the polychromatic erythrocytes was noted.
The positive control (CPA) induced 2.030 % of MN in PCEs (0.08 % in the control animals: significance p 0.0040).
In the treated animals with 100 mg/kg a percentage of MN 0.150 (24h) and 0.110 (48h) was observed: these values, although higher than the control, had a p > 0.34. A reduction of PCE was observed, thus indicating a cytotoxic effect of the test item in the bone marrow cells.
Acid Red 92 is non mutagenicintheIn vivo Mammalian Erythrocyte Micronucleus Test performed.
In accordance with the CLP classification, 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS Number: 18472-87-2)is non mutagenic.
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