Registration Dossier
Registration Dossier
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EC number: 942-795-5 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- The structure of the read-across substance is the para form of the CJ301 without the meta form. However, this difference does not influence the toxicity of the CJ301. CJ301 contains Li/Na salt form and the read-across substances contains only Na salt. This will not lead to difference on the toxicity results.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium sodium 5-(5-(4-chloro-6-(4-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinemethanesulfonate
- Cas Number:
- 111850-26-1
- Molecular formula:
- C24H23ClN8O11S3.xK.yNa
- IUPAC Name:
- Potassium sodium 5-(5-(4-chloro-6-(4-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinemethanesulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: OF-1 SPF
Administration / exposure
- Route of administration:
- oral: unspecified
- No. of animals per sex per dose:
- Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 20 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 68 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 20 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 44 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 68 hours
Results and discussion
Any other information on results incl. tables
Der Test wurde für einen Meldevorgang nach der 6. Änderung der Richtlinie 67/548/EWG durchgeführt
Applicant's summary and conclusion
- Conclusions:
- No symtoms of toixicty oberserved at the 5000 mg/kg/bw dose.
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