Reaction mass of Sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-,Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]naphthalen-2-olato(2-)]cobaltate(1-)and Sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)

Endpoint summary

Description of key information

Acute oral toxicity: A study according OECD TG 423 was performed and the acute oral LD50 was calculated to be > 375 < 2500 mg/ kg bw in female Wistar rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Quality of whole database:

OECD TG 423

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

Oral

In an acute oral toxicity study performed according to OECD TG 423 (Acute Toxic Class Method), doses of 2500 and 375 mg/kg bw of the test item preparations in corn oil were given by gavage to three test groups of three fasted Wistar rats each (2500 mg/kg bw in 3 females, 375 mg/kg bw in 6 females).

Mortality of two animals was observed in the 2500 mg/kg bw group. Furthermore, the following test substance-related clinical observations were recorded: impaired general state in all animals, dyspnoea in all animals, piloerection in all animals, cowering position in all animals, staggering in two animals, diarrhea in all animals, exsiccosis in one animal, red-brown discolored feces in all animals, body weight reduction in all animals and smeared fur with feces in one animal.

In one animal that died dark discoloration of the liver was detected. Due to advanced putrefaction no macroscopic pathological findings could be determined in the second animal.

In both test groups of the 375 mg/kg bw dose, no mortality occurred. The following clinical signs were recorded for the first test group: impaired general state in two animals, piloerection in two animals, smeared fur with feces in one animal, red-brown discolored feces in one animal and black discolored feces in three animals.

In the second test group of the 375 mg/kg bw group the following clinical sings were detected: impaired general state in one animal and piloerection in one animal.

There were no macroscopic pathological findings in the surviving animals of the 375 mg/kg bw group sacrificed at the end of the observation period.

The single surviving animal of the 2500 mg/kg bw test group lost body weight within the first 3 days after administration but gained weight in a normal range for the remainder of the observation period. In both 375 mg/kg bw test groups the body weight increased normally during the study period with one exception in the first 375 mg/kg bw test group. In this animal the body weight increased during the first observation week but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.

The acute oral LD50 was calculated to be > 375 < 2500 mg/kg bw (Bioassay, 2017).

 

Justification for classification or non-classification

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified for acute oral toxicity Cat.4 (H302: "Harmful if swallowed") under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.