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Administrative data

Description of key information

LD50 (acute oral, rats)> 300 < 2000 mg/kg b.w. 
LD50 (acute dermal, rats) > 2000 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
> 300 - < 2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

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

According to the CLP Regulation (EC) No.1272/2008 Annex I: 3.1.2.1.: "Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE)."


The LD50 obtained in the acute dermal toxicity study is above 2000 mg/kg bw and therefore no classification applies. However, the LD50 obtained in the acute oral toxicity is between 300 mg/kg bw and 2000 mg/kg bw and for this reason the substance is classified in Category 4 (H302) according to the CLP classification criteria.