Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-909-9 | CAS number: 4548-53-2
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviwed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic Toxicity of Ponceau SX to Rats, Mice, and Dogs
- Author:
- K. J. DAVIS, A. A. NELSON, R. E. ZWlCKEY, W. H. HANSEN, AND O. G. FITZHUGH
- Year:
- 1 966
- Bibliographic source:
- TOXICOLOGY AND APPLIED PHARAMACOLOGY 8, 306-317 (1966)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- The experiment was undertaken to provide data on chronic toxicity of test chemical Ponceau SX.
- 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): Ponceau SX- 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:
- other: C57B1/He
- 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: No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): commercial laboratory chow diet- Water (e.g. ad libitum): No data available- 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
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- other: Not applicable
- Vehicle:
- other: diet
- Details on exposure:
- - Mixing appropriate amounts with (Type of food): laboratory chow diet
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 2yrs
- Frequency of treatment:
- Daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:2.0, 1.0 or 0.0% dietary levels (3333.3, 1666.6 and 00% mg/kg) Basis:no data
- No. of animals per sex per dose:
- 50 rats per sex per dose
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- HAEMATOLOGY: Yes
- 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
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITYGrowth effect was negligible, and there was no effect on survivalBody weight and weight gain:No data availableFood consumption and compound intake: No data availableFood efficiency: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data availableOPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGY: No effect of chemical were observedCLINICAL CHEMISTRY: No data availableURINALYSIS: No data availableNEUROBEHAVIOUR: No data availableORGAN WEIGHTS: No effect of chemical were observedGROSS PATHOLOGY: Gross lesions most commonly seen were tumors and granular kidneys but none was related to Ponceau SX treatment.HISTOPATHOLOGY: NON-NEOPLASTIC: No data availableHISTOPATHOLOGY: NEOPLASTIC (if applicable)No data availableHISTORICAL CONTROL DATA (if applicable) No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3 333.3 other: mg/kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Non- carcinogenic
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
- Conclusions:
- After 2 yrs study Ponceau SX (4548-53-2) was found to be non-carcinogen to C57B1/He mice.
- Executive summary:
The carcinogenicity test was performed on C57B1/He mice. Different concentrations of Ponceau SX (4548-53-2)0, 2% and 1%
(3333.3, 1666.6 mg/kg) )were used. For treated group 50 animals per sex per dose and control group 100 animals per sex per dose were used. Various parameters were tested are, number of survivors at 80 weeks,number received by Pathology,number of males and female with tumors,Tumor type,Other pathology were studied. From various other findings, such as liver enlargement, abscesses, distendedurinary bladders, ovarian cysts, distended uteri, enlarged parathyroids, enlarged seminal vesicles and other miscellaneous changes, and were present in approximately equal incidence and degree in test and control mice.Therefore, After 2 yrs study Ponceau SX (4548-53-2) was found to be non-carcinogen toC57B1/He mice at dose concentration 3333.3 mg/kg.Thus NOAEL for this study considered to be 3333.3 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
