Registration Dossier
Registration Dossier
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EC number: 226-109-5 | CAS number: 5281-04-9
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:
- 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 toxicity studies
- Author:
- Leist et al.
- Year:
- 1 982
- Bibliographic source:
- Ecotoxicology and Environmental Safety
- Reference Type:
- secondary source
- Title:
- Scientific Opinion on the re-evaluation
- Author:
- EFSA
- Year:
- 2 010
- Bibliographic source:
- EFSA Journal
- Reference Type:
- secondary source
- Title:
- IUCLID Data set
- Author:
- EUROPEAN COMMISSION – European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- EUROPEAN COMMISSION – European Chemicals Bureau
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute Oral toxicity study of calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no. 5281-04-9) in rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate
- Details on test material:
- - IUPAC Name: calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Common Name: D & C Red no. 7- InChI:1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Smiles:c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- Name of test material (as cited in study report):C. I. Pigment 57:1- Molecular formula :C18H12CaN2O6S- Molecular weight :424.445 g/mol- Substance type:organic- Physical state:solid
Constituent 1
- Specific details on test material used for the study:
- - IUPAC Name: calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Common Name: D & C Red no. 7- InChI:1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Smiles:c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- Name of test material (as cited in study report):C. I. Pigment 57:1- Molecular formula :C18H12CaN2O6S- Molecular weight :424.445 g/mol- Substance type:organic- Physical state:solid
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- not specified
- Doses:
- 2000 mg/kg and 5000 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days -Other examinations performed: Animals were observed for mortality and clinical signs.
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed at dose 5000 mg/kg bw
- Clinical signs:
- other: No signs of toxicity were observed.
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral toxicity dose (LD50) was considered to be >5000 mg/kg bw, when rats were treated with calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate via oral route.
- Executive summary:
Acute oral toxicity study was conducted in rats using test material calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate (CAS no. 5281-04-9) at the dose concentration of 2000 or 5000 mg/kg bw. Animals were observed for mortality and clinical signs. No mortality was observed at dose 5000 mg/kg bw. No signs of toxicity were observed. Therefore, LD50 was considered to be >5000 mg/kg bw, when rats were treated with calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate via oral route.
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