(1) LD50 oral in rats

(2) LD50 dermal in rats or rabbits

The LD50 may be determined by a recognized method.

The LD50 should be determined by a recognized method.

LD50 (median lethal dose) is a statistically derived single dose of a substance that can be expected to cause death in 50 % of dosed animals.

100 LD50 units

200 < LD50 <= 2000 mg/kg,

400 < LD50 <= 2000 mg/kg.

Strength Not less than 1000 LD50 units

R 22 Harmful if swallowed Acute toxicity results: - LD50 per oral, rat:

R 21 Harmful in contact with skin Acute toxicity results: - LD50 dermal, rat or rabbit:

QHO = dose/oral LD50 (ig a.s. per bee)

QHC = dose/contact LD50 (ig a.s. per bee)

95 % confidence interval for the LD50 (where this can be provided),

95 % confidence interval for the LD50 (where this can be provided);

Xeomin 100 LD50 units powder for solution for injection [ See Annex I - To be completed nationally ]

TERa = LD50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)

One LD50 unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.

The test should provide the acute oral and contact LD50 value of the active substance.

The test should provide the LD50 values (by oral and contact exposure).

Cladribine is moderately acutely toxic to mice, with an LD50 of 150 mg/ kg by intraperitoneal administration.

The LD50 value is expressed in terms of weight of test substance per unit weight of test animal (milligrams per kilogram)

The LD50 value is expressed in terms of weight of test substance per unit weight of test animal (milligrams per kilogram).

Each dose of half a millilitre contains not less than 1000 LD50 units of the virus, which is a measure of the actions of the virus in animals.

LD50 value for the sex subjected to a full study, determined at 14 days with the method of determination specified;

LD50 value for the sex subjected to a full study determined at 14 days (with the method of determination specified),

The data should be sufficient to produce a dose/response curve and, where possible, permit an acceptable determination of the LD50.

The oral LD50 is approximately 300 mg zinc/ kg body weight (about 100 to 150 times the human therapeutic dose).

1 vial contains 100 LD50 units of Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins

1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.

When at a dose of 2 000 mg/kg body weight, one animal per sex dies, the LD50 value is expected to exceed 2 000 mg/kg body weight.

discussion of the results (particular attention should be given to the effect that humane killing of animals during the test may have on the calculated LD50 value),

For acute toxicity, the LD50 or LC50 value or, where the fixed dose procedure has been used, the discriminating dose shall be derived.

* One unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.

discussion of results (particular attention should be given to the effect that humane killing of animals during the test may have on the calculated LD50 value);

recommended for toxic substances and preparations if the LD50 dermal value is unknown but the substance or preparation is likely to be toxic through skin contact,

Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins

Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins

Due to differences in the LD50 assay, these units are specific to Xeomin and are not interchangeable with other Botulinum toxin preparations.

recommended for toxic substances and preparations if the LD 50 dermal value is unknown but the substance or preparation is likely to be harmful by skin contact,

TERa = LD50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight) TERst = LC50 (mg a.s./kg food) / ETE (mg a.s./kg food) TERlt = NOEC (mg a.s./kg food) / ETE (mg a.s./kg food) where ETE = estimated theoretical exposure.

The pharmaceutical form (powder and solvent for suspension for injection) and the strength (each 0.5ml dose contains live yellow fever virus not less than 1000 LD50 units) are identical for all countries.

For acute toxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or, where the fixed dose procedure has been used, the discriminating dose shall be derived.

The test should provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.

The test should provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery and the NOEL, and must include relevant gross pathological findings.

if facts show that for the purposes of classification it is inadvisable to use the LD50 or LC50 values as a principal basis because the substances or preparations produce other effects, the substances or preparations shall be classified according to the magnitude of these effects.

Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.

classification as very toxic, toxic or harmful shall be effected by determining the acute toxicity of the commercial substance or preparation in animals, expressed in LD50 or LC50 values with the following parameters being taken as reference values:

Yellow fever virus1 17 D-204 strain (live, attenuated) …………………….not less than 1000 LD50 units2 1 produced in specified pathogen-free chick embryos 2 The statistically determined lethal dose in 50% of animals tested

Dependent on the toxicity of the substance, a limit test approach to a full LD50 may be considered, although no limit test is specified in inhalation studies, because it has not been possible to define a single inhalation exposure limit value.