Registration Dossier

Administrative data

Description of key information

In the study of Chibanguza (1988) the acute oral toxicity (LD50) of Cholorange(2 -Amino-6 -chloro-4 -nitrophenol) was determined orally on male and female rats.Crl.:(WI) BR - Wistar rats.

The test substance was administered as a 20% dilution in aqua deionto animals orally by stomach tube at a limit dose of 2000 mg/kg bw to ten animals (5 males and 5 females).

Post treatment, animals were examined for mortality and clinical signs at about 20 minutes, 1h, 2 h, 3h, 6 h, 24h, 48 h and thereafter once daily up to Day 14. Body weights were recorded on Day 0, Day 7 and on Day 14. After 14 days of observation, all surviving animals were subjected to complete gross necropsy following their sacrifice at the end of Day 14 or spontaneous death. No mortality was observed during the study.Red-orange-stained bedding (urines red-orange-stained) was observed up to 5 days post administration.Body weights changes after each observation period showed a normal weight gain. No macroscopic findings were noted during necropsy.

Based on above, the acute oral toxicity (LD50) of Cholorange was determined to be > 2000 mg/kg bw.Therefore, this test substance is not classified according to EU criteria for classification.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliability 1

Additional information

Justification for classification or non-classification

Based on above, the acute oral toxicity (LD50) of Cholorange was determined to be > 2000 mg/kg bw.Therefore, this test substance is not classified according to EU criteria for classification.