Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The LD50 value for acute oral toxicity was > 300 < 2000 mg/kg b.w. in rats, the LD50 for acute dermal toxicity was > 2000 mg/kg b.w. in rats.

Key value for chemical safety assessment

Additional information

Oral exposure route:

In an acute oral toxicity study (BASF SE, 2010) performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test-item 4-Nitrotoluene-2-sulphonic acid (preparation in doubly distilled water) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner. All animals of the 2000 mg/kg test group were found dead within 2 days after the administration. No mortality occurred in the six females administered 300 mg/kg bw.

Clinical observation in the 2000 mg/kg bw test group revealed impaired and poor general state, dyspnoea, staggering, salivation, non feces, hemorrhagic urine, piloerection, ataxia and exsiccosis at hour 0 until study day 1 after administration. No clinical signs were observed in the first 300 mg/kg administration group. Clinical observation in the second 300 mg/kg test group revealed impaired general state, piloerection and dyspnoea in one animal from hour 1 until hour 2 after administration.

Dermal exposure route:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of 4-Nitrotoluene- 2-suphonic acid (as suspension in doubly distilled water) to the clipped skin and covered by semi occlusive dressing for 24 hours. No mortality occurred. (BASF SE, 2010)

Justification for classification or non-classification

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

- Harmful if swallowed, R 22

GHS classification (EU GHS, CLP 1272/2008)

- Harmful if swallowed, Category 4