Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Endpoint summary

Description of key information

LD50 (oral, rat) ca. 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

The acute oral toxicity was evaluated in a test performed on rats similarly to the OECD Guideline 401 method. Based on the results obtained in the preliminary study, five males and five females were dosed by oral gavage at concentration of 5000 mg/kg bw. Animals were observed for 14 days after the treatment and at the end of the study period all animals were necropsied.

The LD50 was found to be about 5000 mg/kg bw.

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) acute toxicity is defined as “those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours”. A substance can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route. The numeric criteria based on the acute toxicity estimates (ATE) in mg/kg bodyweight are presented in Annex I, Part 3, Table 3.1.1. For acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000".

Based on the available experimental data of acute oral toxicity (LD50 ca. 5000 mg/kg bw), no classification for acute oral toxicity is warranted under the CLP Regulation (EC 1272/2008).