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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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
Value:
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.