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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.