Registration Dossier
Registration Dossier
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EC number: 458-890-5 | CAS number: 2138848-94-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 458-890-5
- EC Name:
- -
- Cas Number:
- 2138848-94-7
- Molecular formula:
- C35H31N8O18S3.xNa.yK, where x+y=3
- IUPAC Name:
- dipotassium sodium 3-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-2-sulfonatophenyl}diazen-1-yl]-2,5-bis(2-hydroxyethoxy)phenyl}diazen-1-yl]-4,5-dihydroxynaphthalene-2,7-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
- Clinical signs:
- other: Signs of toxicity related to dose levels: There were no deaths Clinical observations: Signs of systemic toxicity noted during the study were hunched posture, ataxia and black staining of the urine and faeces. All animals appeared normal thre
- Gross pathology:
- Effects on organs:
All animals showed expected gains in body weight over the
study perod.
Necropsy:
No abnormalities were noted at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
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