Registration Dossier
Registration Dossier
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EC number: 402-480-0 | CAS number: 111850-26-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 402-480-0
- EC Name:
- -
- Cas Number:
- 111850-26-1
- Molecular formula:
- C24H23ClN8O11S3.xK.yNa
- IUPAC Name:
- potassium disodium 4-({4-chloro-6-[(4-sulfophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-[(E)-2-[1-ethyl-6-hydroxy-4-methyl-2-oxo-5-(sulfomethyl)-1,2-dihydropyridin-3-yl]diazen-1-yl]benzene-1-sulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: dest. Wasser + 4% CMC-Na-salt
- Details on oral exposure:
- Method of administration: Magensonde
- Duration of treatment / exposure:
- Test duration: 28 days
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations: No mortalities occurred.
Effects in organs:
Yellow colouration of the skin in the neck and back region and of the mucous membrane of some animals from the medium and high-dose groups was a substance-related change. However, it was interpreted as non-toxic. The comparison between all of the examined parametes did not reveal any significant differences between the controls and the treatment groups.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: orignal NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: orignal NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as : Not classified
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