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Description of key information

Basazol Gelb 8511 was tested in a 28 day and 90 d oral gavage study. 
In the 90 d study 2/10 males and 7/19 females of the high dose (180/120 mg/kg) died prematureley due to chronic tympania. The NOAEL was 10 mg/kg bw.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
10 mg/kg bw/day

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 oral administration of Basazol Gelb 8511 caused lethality at 180/120 mg/kg body weight due to chronic tympania. Toxicity was further characterized by mild neutrophilia in both sexes indicating a slight inflammatory reaction. Discoloration of urine and/or feces was seen in all treatment groups. This was, however, related to the physical properties of the test compound (dye stuff) but does not represent a toxicologically relevant effect. The affection of the respiratory system is probably due to an unintentional aspiration of the test substance as a consequence of attempts to vomit the test substance. It may therefore be addressed as a substance-related effect, but not an adverse effect. Thus, under the conditions of this study, the no observed adverse effect level (NOAEL) was 10 mg/kg bodyweight/day in both sexes .

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: other

Justification for classification or non-classification

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

No classification.

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

No classification.