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Administrative data

Description of key information

No experimental data is available. The substance is a metabolite from verious food dyes that are non-toxic in experimental animals. The acute oral toxicity of the sodium salt analogue was tested in rat, the LD50 was considered to be > 5000 mg/kg bw. Also, acute oral toxicity of sulfanilic acid was tested in rats. The LD50 of the free acid was found to be higher than 2000 mg/kg bw. However, no data about dermal  or inhalative toxicity are available.
Therefore, the test substance is considered to be not toxic after single oral application.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

No experimental data about oral, dermal or inhalative acute toxicity of the test material are available. But the substance is a metabolite from verious food dyes that are non-toxic in experimental animals. Moreover, there are several data from study reports, public journals and other literature sources which describe and characterize sulfanilic acid as well as the sodium salt. It is acceptable to derive the acute toxicity from experimental data of sulfanilic acid and the sodium analogue. The potassium salt as well as the sodium salt dissociates in aqueous solution in free sulfanilic acid and the respective ions.

The acute oral toxicity of the sodium salt analogue was tested in rat, the LD50 was considered to be > 5000 mg/kg bw. Also, acute oral toxicity of sulfanilic acid was tested in rats. The LD50 of the free acid was found to be higher than 2000 mg/kg bw. However, no data about dermal or inhalative toxicity are available.

Therefore, the test substance is considered to be not toxic after single oral application.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.