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Administrative data

Description of key information

oral
rat: LD50 >25 <200 mg/kg bw , no signs of toxicity (GLP, comp. OECD 423; BASF AG 1997)
dermal
rat: LD50 > 2000 mg/kg bw (GLP, OECD 402; BASF AG 2006)
inhalation
no data available

Key value for chemical safety assessment

Additional information

There are reliable data available to assess the acute oral and dermal toxicity of the test substance.

oral

A GLP conform study was performed to assess the acute toxicity following oral administration of MGDN (purity: 97.9%) in Wistar rats comparable to the acute toxic class method described in OECD guideline 423 (based on EEC guideline 92/69, B.1; BASF AG 1997).

To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation in Tylose CB 30.000, 0.5%in aqua bidest.. At a dose level of 25 mg/kg body weight was given. Another group of three male rats was treated in the same way with a dose of 200 mg/kg body weight. In both treatments, the dose volume was 10 mL/kg body weight.

Signs of toxicity noted in the 200 mg/kg dose group were poor general state, dyspnoea, apathy, ataxia, tremor, twitching and salivation. The animals of the 25 mg/kg dose group did not show any symptoms.

The expected body weight gain was observed in the course of the study.

All animals of the 200 mg/kg dose group died within 2 hours after application. Necropsy finding of the animals that died was agonal congestion. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Under the conditions of this study the median lethal dose of MGDN after oral application was found to be greater than 25 mg/kg and less or equal 200 mg/kg body weight.

dermal

The GLP conform study was performed to assess the acute dermal toxicity of MGDN in Wistar rats and followed OECD guideline 402 (BASF AG 2006). A single dose of 2000 mg/kg body weight of a test material preparation (purity: 99.5 area-%; dose volume 2.86 g/kg bw) in 0.5% CMC-solution in doubly distilled water was applied in five male and five female animals to ca. 10% of the clipped skin (dorsal and dorsolateral parts of the trunk) and covered by a semi-occlusive dressing for 24 hours.

No mortality occurred. No systemic clinical observations or skin effects were noted in the animals. The mean body weights of the animals increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study, the acute dermal median lethal dose (LD50) of MGDN after dermal application was found to be greater than 2000 mg/kg body weight in male and female rats.

inhalation

no data available

Justification for classification or non-classification

oral

Based on the available data, the oral LD50 is > 25 and <200 mg/kg bw in rats. Therefore, MGDN has to be considered as toxic if swallowed and has to be classified with R25 according to 67/548/EEC. Regarding the complete absence of signs of toxicity at 25 mg/kg bw, it is assumed that the LD50 level is > 50 mg/kg bw. Therefore, Cat. 3 is warranted according to EU-GHS and OECD-GHS, respectively.

dermal

Based on the available data, the dermal LD50 is > 2000 mg/kg bw in rats. No signs were observed at this level. Therefore, no indication is given for classification according to 67/548/EEC, EU-GHS and OECD-GHS, respectively.

inhalation

No data available.