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EC number: 700-736-9 | CAS number: -
An Acute Oral (9 females rats): LD50 = 1000mg/kg
An acute Dermal (5 males and 5 females rats): LD50 > 2000mg/kg
An acute oral toxicity study (Kumamoto Laboratory, 2009) was conducted to assess the toxicity of MTF following a single oral administration to rats.
The study was conducted according to OECD test guideline 423 and in compliance with GLP.
A single dose of the test substance was administered by oral route to female rats Crl:CD(SD) rats.
Dose levels in both experiments 1 and 2 were set at 300 mg/kg, and that in experiment 3 was set at 2000 mg/kg. Three animals were used in each experiment. Clininal observation and body weight measurement were conducted during the observation period and necropsy was performed at the completion of the observation period.
Three animals in experiment 3 (2000 mg/kg) died 2 days after administration (day 3).
In observation for clinical signs, mucous stool or soiled periproctal region was observed in experiments 1 and 2. Besides the findings, hypoactivity, tremor, lateral position, or bradypnea was observed in dead animal in experiment 3.
In surviving animals in experiments 1 and 2, mucous stool or soiled periproctal region all disappeared by 2 days after administration.
There were also changes to the body weights after administration and in dead animals.
An acute dermal toxicity study (Huntingdon Life Sciences, 2013) was conducted to assess the toxicity of MTF following a single dermal exposure to rats.
The study was conducted according to OECD test guideline 402, EC test guideline B3, and US EPA OPPTS 870.1200, and in compliance with GLP.
A group of ten rats (five males and five females) received a single topical application of the test substance, as supplied, at a dose level of 2000 mg/kg bodyweight, for duration of 24 hours. The animals were retained for a 14 day observation period during which clinical signs, dermal reaction and bodyweight investigations were performed.
There were no deaths and no systemic response to treatment in any animal. Very slight erythema (barely perceptible) was seen in four males and five females. These reactions had resolved by Day 11. A bodyweight loss was noted for four females on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
No inhaled toxicity study was conducted, as the requirement for an acute toxicity study by a second route of exposure was satisfied by the dermal toxicity study, noted above. It is considered unlikely that MTF will be available in a vapour or other airborne / inhalable state.
The LD50 by oral administration was determined to be 1000 mg/kg bodyweight in rats.
According to the CLP Regulation (Regulation (EC) 1272/2008), classification as Acute Toxiticy Category IV applies when the LD50 is greater than 300 mg/kg but equal to or less than 2000 mg/kg. On this basis, MTF, will be calssified Acute Toxicity (oral) category IV; the signal word "Warning" and the Hazard statement "H302: Harmful if swallowed" are applicable. The corresponding classification according to the Dangerous Substances Directive (Directive 67/548/EEC, DSD) is "R22, Harmful if swallowed", applicable when the acute oral LD50 is between 200 and 2000 mg/kg.
The LD50 by dermal administration to rats was determined to be greater than 2000 mg/kg; on this basis no classification is required for dermal toxicity according to either the CLP regulation, or the DSD.
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