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Bulgaria - Final Regulatory Action
Captafol CAS number:
2425-06-1
Date circular:
12/12/2005

Chemical name: 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-[(1,1,2,2-tetrachloroethyl)thio]-

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Banned

Use or uses prohibited by the final regulatory action:

All formulations and uses are prohibited.

Pesticide use or uses that remain allowed:

No remaining uses allowed.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

Captafol was excluded from the list of active substances authorized for use in plant protection products in 1986 under the Law on protection of plants against pests and blights. It has prohibited to production, use and place on the market all plant protection products containing Captafol according to annual adopted list of active ingredients banned for use in plant protection products under the lant Protection Act. Captafol is designated as a PIC chemical. (Annex I of the Regulation on the import and export of certain dangerous chemicals on the Bulgarian territory). The chemical is listed in Annex II of the Regulation as prohibited for export from and import in the country.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Captafol has caused allergic and contact dermatitis in man. During occupational exposure, it has also been reported to cause severe irritation of the respiratory tract and allergic dermatitis, eye damage, and other systemic effects. In a limited study of employees involved in the manufacture of captafol, no significant excess in mortality could be associated with exposure to this pesticide.
In view of the severe toxicity induced in experimental animals with repeated exposure, including a proven carcinogenic action, exposure of human beings should be kept to a minimum.

Expected effect of the final regulatory action in relation to human health:

Decrease of hazards and risks to human health.

Summary of known hazards and risks to the environment:

Captafol, administered as a single oral dose, or in short-term dietary studies, was not toxic for birds (LC50 >5620 mg/kg diet). However, high levels of exposure may cause reproductive impairment. The toxicity of captafol for bees is low. Captafol is highly toxic for fish and moderately to very highly toxic for freshwater invertebrates (96-h LC50s ranged between 0.04 and 3 mg/litre). The 96-h LC50 reported in three investigations on rainbow trout ranged from 0.027 to 0.19 mg/l.
Captafol is not persistent and small quantities of the compound are readily hydrolyzed in soil and surface waters. Its half-life in soil is less than 11 days. The environmental impact of the pesticide is likely to be limited by its high chemical reactivity, high rate of biodegradation, and lack of tendency to bioaccumulate. However, because of its demonstrated high toxicity, exposure of aquatic organisms to captafol through drift and/or run-off is a cause for concern. Fish kills have been associated with the use of this pesticide. Contamination of ponds, waterways, and ditches with captafol should be avoided.

Expected effect of the final regulatory action in relation to the environment:

To avoid exposure of the chemical and the related risks to the environment.

Date of entry into force of the final regulatory action: 01/04/2003