Registration Dossier
Registration Dossier
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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
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
Materials and methods
Test guideline
- 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:
- Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
- EC Number:
- 403-530-4
- EC Name:
- Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
- Cas Number:
- 129423-54-7
- Molecular formula:
- C17H15ClN4O7S2.Ca
- IUPAC Name:
- calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Hoe: WISKf
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: sesame oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
62.5 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
25 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 62.5 mg/kg bw/day
Male: 5 animals at 250 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 62.5 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No mortalities or symptoms of toxicity occured during the test period.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortalities or symptoms of toxicity occured during the test period.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No changes to the measured values.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The urine of the animals from the high-dose group had a reduced specific weight
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No substance-related changes.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- male/female
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Not classified.
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