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Administrative data

Description of key information

Valid acute toxicity data for the oral route of exposure are available for the test item DMAC Trocken Flüssig.
The test item was tested in Wistar rats according to the OECD TG 401 (1981) in BASFAG81/366 (1982).
For the males, the LD50 was > 5000 mg/kg bw
No data are available for the dermal and the inhalative route of exposure.
For the females, the LD50 was > 3160 — < 5000 mg/kg bw

Key value for chemical safety assessment

Additional information

Referring to the oral route, the test item first was tested at a dose level of 3160 mg/ kg bw in Wistar rats of both sexes according to the OECD TG 401 (1981); in this study, no mortalities occurred and therefore the LD50 for both sexes was set > 3160 mg/kg bw (BASFAG81/366[1981]). A further test was conducted under conditions similar as above; this time, the following dose levels were considered: 2150, 3160 and 5000 mg/kg bw (BASFAG81/366[1982]).

None of the male and female animals treated with 2150 and 3160 mg/kg bw died. At 5000 mg/kg bw, 2/5 males and 4/5 females died within 1 hour after treatment. Clinical symptoms only were seen in the high dose group, generally about 15 minutes to 4 hours after treatment. Males mainly suffered from dyspnoea, apathy, staggering, convulsion, diarrhea, and poor general state. Females mainly suffered from dyspnoea, apathy, abnormal position, staggering, convulsion, tremor, ruffled fur, diarrhea, cyanosis, breathlessness and poor general state. Body weights and body weight gain for the surviving animals of both sexes were inconspicuous. Necropsy of those animals that died revealed general congestive hyperemia and atonic intestines with diarrheic content. Necropsy of the animals that survived revealed no abnormalities.

Thus, the LD50 for both sexes was between 3160 and 5000 mg/kg bw.

Justification for classification or non-classification

For the oral route of exposure, a valid study revealed a LD50 for male and female rats that is > 3160 and < 5000 mg/kg bw.

According to the EU Directive 67/548/EC, no classification is needed.

According to the CLP Regulation 1271/2008, no classification is needed.