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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: 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 authorative handbook source
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- The acute oral toxicity study of substance FD&C Red No. 4 in rat.
- Author:
- Maryadele J ‘O Neil
- Year:
- 2 006
- Bibliographic source:
- Merck Index (14th edition, Merck´s publishing); 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- The acute oral toxicity study of substance FD&C Red No. 4 in rat.
- GLP compliance:
- not specified
- Test type:
- other: no data
- Limit test:
- yes
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:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 value of substance FD&C Red No. 4 is considered to be >2000 mg/kg in rat.
- Executive summary:
Acute oral toxicity study was conducted to evalaute the toxic nature of the test compound FD and C Red no 4 in rats. The acute oral LD50 value of substance FD&C Red No. 4 is considered to be >2000 mg/kg in rat.
As per the CLP classification, the test material does not classify as an acute oral toxicant.
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.
