Registration Dossier

Administrative data

Description of key information

Oral LD50 values ranged from 1250 to 1807 mg/kg bw/day for cats, guinea pigs, mice and rats. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 250 mg/kg bw

Additional information

Non-human data:

Data on acute toxicity of phenazone were available for different species and several LD50 values for acute toxicity after oral application were reported:

In two oral acute toxicity studies with mice LD50 values of 1310 and 1492 mg/kg bw/day were reported.

In two oral acute toxicity studies with rats LD50 values of 1705 and 1807 mg/kg bw/day were reported.

In an oral acute toxicity study with cats a LD50 of 1250 mg/kg bw/day was reported.

In an oral acute toxicity study with guinea pigs a LD50 of 1492 mg/kg bw/day was reported.

General clinical symptoms for acute toxicity in rodents are decrease in motility, incoordination, tonoclonic or tonic spasm. Spasms were reported predominantly after administration of lethal doses. Symptoms of acute toxicity subside after one day. After 2-3 weeks no macroscopic organ damages were detectable.

Data on acute toxicity of phenazone were available for acute toxicity following administration via alternative routes were reported:

In a subcutaneous acute toxicity study with mice a LD50 of 1000 mg/kg bw/day was reported.

In an intraperitoneal acute toxicity study with mice a LD50 of 750 mg/kg bw/day was reported.

In an intravenous acute toxicity study with mice a LD50 of 500 mg/kg bw/day was reported.

Human data:

No data available.

Justification for classification or non-classification

Oral:

Based on Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP), phenazone was classified as hamful if swallowed ( Xn, R22; cat 4, H302).

Inhalation:

Based on Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP), phenazone was not classified for acute inhalative toxicity.

 

Dermal:

Based on Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP), phenazone was not classified for acute dermal toxicity.