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Administrative data

Description of key information

The test substance is harmful after a single oral application (LD50 rat oral ca. 2000 mg/kg) and virtually nontoxic after a single dermal application (LD50 rat dermal > 2000 mg/kg).

Key value for chemical safety assessment

Additional information

The data discussed in this section were derived from toxicity studies with the hydrochloride of the same azo dye (read-across to Basisch Gelb 8511, CAS 118208-02-9).

The acute toxicity of Basazol Gelb 8511 was tested in an OECD Guideline 401 (acute oral toxicity) and OECD Guideline 402 (acute dermal toxicity) test in rats. After oral application the LD50 was ca. 2000 mg/kg in female rats and > 2200 mg/kg in male rats. In the dermal study no toxicity or mortality was observed at 2000 mg/kg.

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

- harmful after oral application, R 22

- practically nontoxic after dermal application

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- oral route: category 4

- dermal route: no classification required