Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)

Endpoint summary

Description of key information

Acute oral toxicity, LD50: > 2000 mg/kg bw





































  
  
  
  
  
  
  
  
  
  
  
  
  








































      
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

Acute inhalation toxicity: waiving
Acute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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.

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.

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.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral Toxicity

The acute oral toxicity was determined according to the OECD Guideline 401 (Acute Oral Toxicity) and EU Method B.1 (Acute Toxicity (Oral), in GLP.

LD50 in rats of both sexes is greater than 2000 mg/kg body weight.

In another test, performed not in GLP, but according to OECD 401, the LC50 was found to be > 5000 mg/kg bw (male and female).

In two studies, performed not in GLP and without guideline reported, the acute oral LD50 of the substance in rats of both sexes observed over a period of 14 days was found to be greater than 10000 mg/kg.

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 values are > 2000 mg/kg/body weight.

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.