Registration Dossier
Registration Dossier
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EC number: 458-890-5 | CAS number: 2138848-94-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute 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:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Duration of exposure:
- 24 h
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Black staining of the urine was noted in all the animals one to three days after treatment. There were no signs of systemic toxicity noted during the study.
- Gross pathology:
- Effects on organs:
No effects on organs related to the dose level were
observed. No abnormalities were noted at necropsy. - Other findings:
- Signs of toxicity (local):
Black staining was noted at all treatment sites one to six
days after the treatment. This did not affect the evaluation
of dermal reactions. There was no signs of dermal irritatio
n
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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