Registration Dossier
Registration Dossier
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EC number: 247-368-0 | CAS number: 25956-17-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Acute dermal toxicity study of test chemical was performed in rabbits.
- Author:
- J. F. Borzelleca et. al.
- Year:
- 1 989
- Bibliographic source:
- food and chemical toxicology
- Reference Type:
- publication
- Title:
- WHO Food Additives Series
- Author:
- WHO
- Year:
- 2 017
- Bibliographic source:
- World Health Organization
- Reference Type:
- publication
- Title:
- Toxicological Evaluation of Certain Food Additives
- Author:
- WHO
- Year:
- 1 980
- Bibliographic source:
- WHO
- Reference Type:
- review article or handbook
- Title:
- Acute dermal toxicity study of test chemical in rodents.
- Author:
- Richard J. Lewis
- Year:
- 2 012
- Bibliographic source:
- Sax's Dangerous Properties of Industrial Materials
- Reference Type:
- other: authoritative database
- Title:
- Acute Dermal toxicity - Test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: authoritative database
- Title:
- Acute studies in rodents.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 012
- Bibliographic source:
- HSDB
- Reference Type:
- secondary source
- Title:
- Environment and Quality of Life
- Author:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC)
- Year:
- 1 988
- Bibliographic source:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC),1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity study of the given test chemical was performed in rabbit.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Details on test material:
- - IUPAC Name: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Common Name: Allura Red AC
- InChI: 1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)
(H,25,26,27);; /q;2*+1/p-2/b20-19+;;
- Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N =N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O. [Na+].[Na+]
- Molecular formula :C18H14N2Na2O8S2
- Molecular weight:496.4266 g/mole
- Substance type:organic
- Physical state:Solid, Dark red powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- not specified
- Duration of exposure:
- not specified
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 10000 mg/kg bw in treated animals.
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute dermal toxicity dose (LD50) value was considered to be >10000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.
- Executive summary:
Acute dermal toxicity study was conducted by using the given test chemical in rabbits at the dose concentration of 10000 mg/kg bw.
Animals were observed for mortality. No mortality was observed at 10000 mg/kg bw in treated animals.
Hence, the LD50 value was considered to be >10000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.
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