Registration Dossier

Administrative data

Description of key information

One key acute rat oral study and one supporting acute rabbit oral study was identified. 
One key acute rabbit dermal study was identified for this compound.
One key acute rat inhalation study was identified.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
725 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
2 186 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

In the key study, groups of 5 rats were administered various doses of 100, 200, 400, 800, and 1200 mg/kg bw of 2 -nitropropane to determine the oral LD50. The results indicated the estimated LD50 was 725 mg/kg +/- 160 mg/kg bw.

In the key study for acute dermal exposure, 5 male and 5 female New Zealand White rabbits were administered 2000 mg/kg of 2 -nitropropane under an occusive bandage for 24 hours and observed for 14 days. None of the animals exhibited signs of toxicity and the treated skin sites did not exhibit any erythema or edema 24 hours after treatment. Therefore, the acute dermal LD50 is >2000 mg/kg.

In the key study for acute inhalation exposure, 8 male Sprague Dawley rats per group were exposed to 367, 405, 461, and 574 ppm of 2 -nitropropane and 10 female Sprague Dawley rats were exposed to 370, 416, 464, 602, and 805 ppm of 2-nitropropane. The animals were exposed to the test material for 6 hours and observed for 14 days. The LC50 value for males was 400 +/- 38 ppm and for females was 720 +/- 46 ppm. This value can be adjusted to a 4 hour LC50 according to Haber's Law where C x T = C* x T*, where C = (400 ppp x 6 hours)/4 = 600 ppm or 2.2 mg/l/4 hours for male rats and C = (720 ppm x 6 hours)/4 hours = 1080 ppm or 3.8 mg/l/4 hours for female rats

Justification for classification or non-classification

Based on the range of acute oral LD50s in male and female rats, 2 -nitropropane can be classified as category 4 according to GHS.

Based on the results of the acute dermal LD50 study in rabbits, 2 -nitropropane is not classifiable under GHS.

Based on the range of acute inhalation LD50s in male and female rats, 2 -nitropropane can be classified as category 3 according to GHS