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Description of key information

ORAL 
LD50 (rat) > 2000 mg/kg bw (acute toxic class method; OECD TG 423) (BASF SE, 2009).
Classification: not classified (EU); Cat. 5 (OECD GHS).
No labeling required.
DERMAL and INHALATION
No data is available / required.

Key value for chemical safety assessment

Additional information

ORAL

In an acute oral toxicity study (BASF, 2009), groups of fasted, approximately 10-week old, female Wistar rats were given a single oral dose of 2-Methyl-3,4-dibrombuttersäureethylester (ca. 98% pure), either undiluted at a dose level of 2000 mg/kg bw (two groups of 3 animals) or as a solution in olive oil at a dose level of 50 mg/kg bw (one group of 3 animals) according to the acute toxic class procedure. After dosing, the animals were observed for 14 days. The study was carried out in accordance with the test guidelines OECD 423, EU B.1, OPPTS 870.1100, and Japan MAFF 8147.

  • Oral LD50 Females > 2000 mg/kg bw
    (No deaths occurred; but clinical symptoms were noted at 2000 mg/kg bw)
  • Oral LD50 Combined > 2000 mg/kg bw (calculated)

2-Methyl-3,4-dibrombuttersäureethylester is of LOW Toxicity based on the LD50 in females.

No mortality was observed in any group. Clinical signs of toxicity were reported for 3 of totally 6 animals of the 2000 mg/kg bw groups and comprised impaired general state, dyspnea, staggering, lacrimation, chromodacryorrhea, diarrhea, exsiccosis, piloerection and reduced feces. No clinical symptoms were noted in the animals given 50 mg/kg bw. There was no adverse effect on body weight gain, and there were no macroscopic pathological findings.

DERMAL and INHALATION

No data is available.

Justification for classification or non-classification

Based on the LD50 exceeding 2000 mg/kg bw, on the lack of mortality and on the occurrence of clinical symptoms, there is no need to classify 2-Methyl-3,4-dibrombuttersäureethylester for acute oral toxicity according to the Directive 67/548/EC. According to the GHS criteria., 2-Methyl-3,4-dibrombuttersäureethylester has to be classified as follows: Acute Oral Toxicity Cat. 5.

Reliable data on acute toxicity via the oral route of exposure is available. Thus, according to the articles 10(a) and 12(1) in connection with Annex VII-X of REACH, data on the acute toxicity via the inhalation and dermal route is not required.

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