Registration Dossier
Registration Dossier
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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Information from migrated NONS file, as per inquiry number 06-2120053365-59- 0000, permission to refer granted by ECHA
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- EC number 401-560-2
Notification number 87-04-0062-02
Result Partly provided (some studies submitted less than 12 years previously)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: mus, NMRI (SPF Han)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- 0.5 % aqueous cremophor emulsion
- No. of animals per sex per dose:
- Male: 7500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 7500 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 7500 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 7500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 7500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 7500 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Results and discussion
Any other information on results incl. tables
The treatment induced toxic signs in the bone marrow but no cyto-toxic effects (PCE/NCE-ratio).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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