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Description of key information

The oral LD50 for male and female rats was greater than 5000 mg/kg bw. Metanilic acid wet (free acid) did not cause any formation of methemoglobin nor did it induce any HEINZ bodies in the blood in the oral toxicity study a female and a male cat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

In an oral toxicity study metanilic acid moist, free acid (5000 mg/kg bw) was administered by oral gavage to 5 male and 5 female Wistar rats (Bayer AG 1980). No signs of toxicity were observed during a 14 day observation period. The LD50 for male and female rats was greater than 5.0 g / kg body weight. Furthermore, in a GLP study, 3-Aminobenzenesulfonic acid was studied for oral toxicity in rats in a single dose toxicity test, according to OECD 401, at doses of 500, 1000 and 2000 mg/kg (NIHS 2008). The single dose toxicity test revealed an LD50 of above 2000 mg/kg for both sexes.
In a non-GLP, non-guideline, oral toxicity study a female and a male cat were administered by oral gavage 10 and 50 mg/kg bw respectively metanilic acid moist (free acid) (in water) (Bayer 1985). Drip blood was collected from an ear vein after 0, 3, 7, 24 and 30 hours. Determined were met-hemoglobin (Met-Hb, hemoglobin with Fe3+) and HEINZ bodies (HK). At a dose Ievel of 10 mg/kg body weight, loss of appetite was observed up to 8 hours after treatment. Otherwise, no abnormal signs or symptoms were observed. The percentage of met-hemoglobin was not increased at both doses. No increase in HEINZ bodies was observed.

Metanilic acid wet (free acid) did not cause any formation of methemoglobin nor did it induce any HEINZ bodies in the blood under the test conditions described.

Justification for classification or non-classification

3 -aminobenzene sulphonic acid is listed on Annex 1 of Directive 67/548/EEC; Xn, R20/21/22.

3 -aminobenzene sulphonic acid is listed to Annex 6 of the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008; Cat. 4, H302, H312, H332.