3-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile

Endpoint summary

Description of key information

Acute toxicity in rats

LD50 = 3980 mg/kg, corresponding to 1592 mg/kg a.i..

LD50 = 4970 mg/kg, corresponding to 1759 mg/kg a.i..

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 592 mg/kg bw

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

Acute oral toxicity of Disperse Red 050 was assessed relying on 2 available studies from 1974 and 1986. Due to a well-detailed descriptioon of test methods and results, the study from 1974 was selected as key study. In both studies, LD50 values were recalculcated based on the active ingredient content, due to the low purity of tested samples, ranging from 35 to 40 % of active ingredient. Remaining components were mainly natural dispersing agents, e.g. sodium lignosulphonate, for which no indication of toxic potential was known.

In the study from 1974, test sample composition is: 40 % dye and remaining as coupage. A preliminary and a main study were conducted, following up and down method as described in J. Amer. Stat. Assoc. 48 (1953), starting from a dose of 5000 mg/kg. Observations for deaths and clinical symptoms were done for 14 days after administration.

In the main study, no symptoms were seen. Deaths occurred between 5 and 48 h after dosing.

Taking into account the 40 % purity of test material, a LD50 value of 1592 mg/kg bw, as active ingredient, was obtained.

In the study from 1986, no details on procedure and results were available. Based on the 35.4 % content of active ingredient, a LD50 of 1759 mg/kg was obtained.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as LD50 (oral, dermal) or LC50 (inhalation) values as well as acute toxicity estimates (ATE).

 

In available studies in rats, oral LD50 values of 1592 and 1759 mg a.i./kg bw was found.

Accordingly, the test substance was classified for acute oral toxicity in category 4 (LD50 between 300 and 2000 mg/kg bw) in the CLP Regulation (EC 1272/2008).