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EC number: 277-554-7 | CAS number: 73612-40-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 16th September to the 25th of February, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted testing guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 277-554-7
- EC Name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 73612-40-5
- Molecular formula:
- C32H24Cl2CoN10NaO8S2
- IUPAC Name:
- sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: CIBA-GEIGY Limited, Animal Production 4332 Stein / Switzerland
Weight at study initiation: 183 to 211 g
Housing: Macrolon cages (type 4), segregated by sex, were group-housed (5 animals per cage). Within the groups the animals were identified with
numbers from 1 to 5 using picric acid stain on the fur. Standardized soft wood bedding (Société Parisienne des sciures, Pantin).
Diet: rat food -NAFAG, Gossau SG -), ad libitum
Water: ad libitum
Acclimatization: at least for 5 days
ENVIRONMENTAL CONDITIONS
Temperature: 22°C (+/- 2°)
Humidity: 55 (+/- 10) %
Photoperiod (hrs dark / hrs light): 11 hours
15 air changes/h.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- One single dose, per os, by gastric intubation (gavage)
Prior to dosing, the animals were fasted overnight - Doses:
- Volume: 10 ml/kg body weight
- No. of animals per sex per dose:
- 10, 5 rats (5 male, 5 female)
- Details on study design:
- OBSERVATION
Observation period 14 days
Mortality
daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study. The animals recovered within 3 to 4 days.
- Clinical signs:
- Piloerection, hunched posture, exophthalmos, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in all animals.
- Gross pathology:
- All animals dying spontaneously or being sacrificed (either for humane reasons or at termination of the study) were subjected to a complete necropsy.At necropsy, no deviations from normal morphology were found in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- LD50 in male rats: greater than 2000 mg/kg body weight
LD50 in female rats: greater than 2000 mg/kg body weight
LD50 in rats of both sexes: greater than 2000 mg/kg body weight - Executive summary:
The acute oral toxicity was tested on the substance according to OECD 401 and EU B.1. Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for the substance:
LD50 in male rats: greater than 2000 mg/kg body weight
LD50 in female rats: greater than 2000 mg/kg body weight
LD50 in rats of both sexes: greater than 2000 mg/kg body weight
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