Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)

Endpoint summary

Description of key information

The substance was not acutely toxic by the oral rout and after intraperitoneal application. In an inhalation risk test none of the test animals died when exposed to an atmosphere enriched with the test article for 7 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Scientifically acceptable study report

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

In an acute oral toxicity study the test substance was given to groups of 5 female and 5 male rats at concentrations of 2150 and 5000 mg/kg body weight (21.5 % and 35 % of test substance in vehicle) in an 0.5 % aqueous CMC solution. During an observation period of 14 days the clinical signs, mortality, body weight and histological signs were observed. The results showed no mortality, no clinical signs and no negative effects on the body weight (normal development). The LD50 (oral) was above 5000 mg/kg body weight.

Acute inhalation toxicity

An inhalation risk test with rats was conducted according to H .F. Smyth et al.: Am. Ind. Hyg. Ass. J. 95-107 (1962). Six male and six female rats (3 males and 3 females in two tests) were kept for 7 hours at room temperature in an atmosphere enriched with dust of the test substance. The mean concentration was 0.125 mg/L. After 7 hours no mortality was observed and no abnormality of the rat organs was detected. The results of the inhalation risk test only classify a danger, which could occur by inhalation of the test substance. The labelling of an acute toxic effect by inhalation is not possible by the test results alone.

Acute intraperitoneal toxicity

The intraperitoneal toxicity of the test substance was tested on male and female mice (strain NMRI) for a test period of 14 days. The used concentrations were 200, 700 and 2000 mg/kg bw (5 male and 5 female animals per dose rate). In the test with the highest concentration (2000 mg/kg bw) 2 male animals died within 15 minutes after trial start. Within the first hours up to day 1 living animals showed clinical signs like irregular respiration, tremor, convulsion, bad general condition, apathy or symptoms on fur and skin at all concentrations. After day 1 these symptoms disappeared. At beginning of the test a body weight stagnation was visible. At gross pathology intra-abdominal substance residues were found at the two male animals, which died first. Depending on the given dose rate the animals which were sacrificed after the test (at day 14) exhibited intra-abdominal substance residues (200 and 700 mg/kg) or intra-abdominal substance incorporations (2000 mg/kg). Due to the given results a LD50 (male/female) of >2000 mg/kg bw was determined.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No 1272/2008.