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EC number: 224-909-9 | CAS number: 4548-53-2
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviwed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- SKIN PAINTING STUDIES IN MICE ON 11 FD&C AND D&C COLORS: F D & CGre en NO. 3, Red No. 2, Red No. 4, Yellow No. 6, and External DC No. 7, D&C Orange No. 4, Violet No. 2, Red No. 17, Red No. 34, and Yellow No. 7
- Author:
- STEVEN CARSON
- Year:
- 1 984
- Bibliographic source:
- J. Toxico1.-Cut. & Ocular Toxicol. 3(3), 309-331 (1984)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- The experiment was access the chronic toxicity of test chemical FD&C Red No. 4 on mice skin.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- EC Number:
- 224-909-9
- EC Name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- Cas Number:
- 4548-53-2
- Molecular formula:
- C18H16N2O7S2.2Na
- IUPAC Name:
- disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FD&C Red No. 4- Molecular formula (if other than submission substance): C18H16N2O7S2.2Na- Molecular weight (if other than submission substance): 480.4276- Smiles notation (if other than submission substance): [Na+].[Na+].Cc1cc(C)c(cc1N=Nc2cc(c3ccccc3c2O)S(=O)(=O)[O-])S(=O)(=O)[O-]- InChl (if other than submission substance): 1S/C18H16N2O7S2.2Na/c1-10-7-11(2)16(28(22,23)24)8-14(10)19-20-15-9-17(29(25,26)27)12-5-3-4-6-13(12)18(15)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;- Substance type: Organic- Physical state: Solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: No data available- Age at study initiation: No data available- Weight at study initiation: 17 to 25 g- Fasting period before study: No data available- Housing: All groups were equally divided as to sex. Mice of the same sex were housed five per cage.- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum- Water (e.g. ad libitum): Water ad libitum- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: Distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Each chemical was dissolved in water for application in depilated skin TEST SITE- Area of exposure: Skin- % coverage: 6 cm2- Type of wrap if used: No data available- Time intervals for shavings or clippings: according to the rate of hair growth.REMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableTEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml- Concentration (if solution): 1.0% of the respective color - Constant volume or concentration used: yes- For solids, paste formed: Not applicableVEHICLE- Justification for use and choice of vehicle (if other than water): No data available - Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 19.5 months
- Frequency of treatment:
- Twice weekly
Doses / concentrations
- Remarks:
- Doses / Concentrations:1428.5 mg/kg ( 0.1 ml)Basis:no data
- No. of animals per sex per dose:
- 50 animal/sex
- Control animals:
- yes
- Details on study design:
- 50 mice/ sex/dose were used and 0.1 ml of the test material was applied to the dorsal of each mouse with rubber applicator.Animals that died, those sacrificed moribund and those surviving the 19.5 month experimental period were necropsied and tissues were preserved in 10% formalin.
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data DETAILED CLINICAL OBSERVATIONS: YesDERMAL IRRITATION (if dermal study): No data BODY WEIGHT: YesFOOD CONSUMPTION:- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No dataFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No dataWATER CONSUMPTION: No data OPHTHALMOSCOPIC EXAMINATION: No dataHAEMATOLOGY: No dataCLINICAL CHEMISTRY: No data URINALYSIS: No dataNEUROBEHAVIOURAL EXAMINATION: No data OTHER: No data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes HISTOPATHOLOGY: Yes
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs: no effect on growth, behavior, or survival indicative of a dose related effect was observed.Mortality: no significant difference between treatment and control groups .BODY WEIGHT AND WEIGHT GAIN-Body weight of treated and control groups have no significant difference.FOOD CONSUMPTION-No data availableFOOD EFFICIENCY-No data availableWATER CONSUMPTION-No data availableOPHTHALMOSCOPIC EXAMINATION-No data availableHAEMATOLOGY-No data availableCLINICAL CHEMISTRY-No data availableURINALYSIS-No data availableNEUROBEHAVIOUR-No data availableORGAN WEIGHTS-No data availableGROSS PATHOLOGY-No significant incidence of histo-pathological changes.HISTOPATHOLOGY: NON-NEOPLASTICHISTOPATHOLOGY: NEOPLASTIC (if applicable)-No data availableHISTORICAL CONTROL DATA (if applicable)-No data availableOTHER FINDINGS-No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 428.5 other: mg/kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Gross pathology and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The end point for the dermal repeated dose toxicity study was found to be No Observed Adverse effect level (NOAEL) at 1428.5 mg/kg of FD&C Red No. 4 (4548-53-2) when treated to mice.
- Executive summary:
Repeated dermal dose toxicity test was performed on Swiss Webster mice for 19.5 months. 50 animals per sex were used and the distilled water was the vehicle.100 female and 100 male mice were used in each control group.
First the hair was removed and to the depilated area dosage was applied. Each mouse was observed daily for behavior, survival and visible or palable growth.
No abnormalities were observed in treated group as compare with control group and no significant change was observed in gross or histopathology.
Therefore, from the study it was found that the end point for the dermal repeated dose toxicity study was found to be No Observed Adverse effect level (NOAEL) at 1428.5 mg/kg of FD&C Red No. 4 (4548-53-2) when treated to mice.
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