Why was the use of ethephon banned by the FDCA​

Explanation:

Toxicity

Ethephon is corrosive in acute dermal irritation studies using rabbits,

has the potential to cause eye irritation, and has been placed in Toxicity

Category I (the highest of four categories) for these effects. It is moderately

acutely toxic by the oral, dermal and inhalation routes (Toxicity Category

III), and does not cause skin sensitization.

An organophosphate pesticide, ethephon caused plasma cholinesterase

inhibition in a 16-day oral human study and clinical signs of toxicity in a

second study. In a dermal toxicity study using rabbits, skin effects were

observed at all doses.

In a combined chronic/oncogenicity study using rats, plasma and

erythrocyte cholinesterase were inhibited at all doses. At the highest dose

levels, ethephon caused body weight decrease and kidney effects, but no

carcinogenic effects were observed. In a cancer study using mice, no

evidence of treatment related tumors was observed. Ethephon has been

classified as a Group D carcinogen based on "the insufficiency of the weight

of evidence" regarding its cancer-causing potential.

One chronic toxicity study using beagle dogs caused plasma

cholinesterase inhibition at all doses, and smooth muscle atrophy in the gut.

In a second beagle dog study, treatment related effects included decreased

spleen and body weight plus decreased hemoglobin and hematocrit in the

males.

Developmental toxicity studies using rats and rabbits show no

evidence of a potential for developmental effects at doses that are not toxic

to the mother. In a reproductive toxicity study using rats, administration of

the test compound caused decreased survival in the offspring and decreased

body weight gain in adult females, but no effects on fertility, gestation,

mating, organ weights, or histopathology in any generation.

Ethephon was positive in one mutagenicity study and negative in two

others. It does not appear to cause delayed neurotoxicity based on a study

using hens, however studies using mammals are now required as

confirmatory data.

Human poisoning incidents involving ethephon include four cases of

skin injury (irritation) in California as a result of exposure to field residues,

one possible systemic poisoning case, and 29 telephone calls to the National

Pesticides Telecommunications Network reporting eye and skin irritation

from misuse of ethephon, sometimes in combination with other pesticides.

Dietary Exposure

People may be exposed to residues of ethephon through the diet.

Tolerances or maximum residue limits have been established for ethephon in

many raw agricultural commodities, processed foods, and feed. Please see

40 CFR 180.300(a) and (b), 185.2700(a), (b) and (c), and 186.2700(a).

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