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Description of key information

The oral LD50 value of the test item in rats is ca. 1380 mg/kg bw (calculated from nominal dose (30% solution) in study report: 5000 mg/kg bw).
An 7h inhalation exposure of rats to an atmosphere enriched with the test item caused no deaths. The LC50 was >13.6 mg/L and was calculated from the net total of 19.1 g test item applied within 1400 L air.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
1 380 mg/kg bw

Additional information

In an acute oral toxicity study (BASF SE, 1987), groups of young adult rats (5/sex) were given a single oral dose of unchanged test item as a 30% solution at nominal doses of 1500, 948, 645, 300, 139 mg / kg bw, calculated (30%) from the nominal dosages specified in the study report (5000, 3160, 2150, 1000, 464 mg/kg bw). Animals were then observed for 14 days. Oral LD50 combined: ca. 1380 mg/kg bw (calculated from 4600 mg/kg bw, interpolated in study report for both genders). No differences occurred between the sexes. The following treatment related clinical signs were noted: dyspnea, apathy, abnormal position, staggering, atonia, paresis, piloerection, cyanosis, poor general state. Results were supported by a less reliable study (Peters et al., 1978), where an LD50 of 1990 and 1165 mg/kg bw were reported for males and female rats, respectively.

In an acute inhalation toxicity study (BASF SE, 1987), six young adult rats (3/sex) were exposed by inhalation route to an enriched atmosphere of the test item for 7 hours to the whole body at a nominal mean concentration of 13.6 mg/L.  The LC50 was calculated from the net total of 19.1 g test item applied within 1400 L air. Animals then were observed for 14 days. No mortality occurred during this assay. The following clinical signs were noted during exposure: eyelid closure, respiratory rate increased, panting, respiratory sounds, reddish discharge from nose; after exposure: respiratory sounds, reddish discharge from nose (tested positive for blood), stilted gait. Nominal LC50 (combined) from raw data > 13.6  mg/L.

Justification for classification or non-classification

The oral administration of the test item as a 30% solution is harmful (EU: R22; CLP acute oral Cat. 4, H302) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

The test item did not cause deaths after inhalation at the highest dose applicable (calculated air saturation at 13.6 mg/L). A classification for acute inhalation toxicity is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation 1272/2008/EC.