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

Pesticide use or uses that remain allowed:

None

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

Summary of the final regulatory action:

National Constitution. Sanitary Code. Law No. 66, 10 November 1947, notified on 1998.

Law No. 12 of 14 June 2000 approved the Rotterdam Convention for the application of the Prior Informed Consent Procedure for certain hazardous pesticides and chemicals in the international trade, signed in Rotterdam on 10 September 1998.

Law No.1 of 10 January 2001 on medicines and other hazardous products for human health.

Executive Decree No. 305 of 9 September 2002 establishing the automatic cancellation in order to regulate the import of certain potentially hazardous chemical substances (such as substances or controlled hazardous materials), and determining other provisions.

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

Summary of known hazards and risks to human health:

Reducing exposure to risk factor will reduce the effects on direct exposed population (occupational) and indirect exposed population (accidental, environmental or acquired) to this product, and this is confirmed by special studies of toxicity on systematized mammals by IRPTC, cataloging Captafol as biochemical interactor, possible carcinogenic to human, mutagenic, producing primer irritation, affecting reproduction and is teratogenic. Producing effects in aquatic and terrestrial organisms.

During the Second Forum of the IFCS it was outlined that other studies were not necessary if the information was validated and confirmed by experts. However, the communication of risk evaluation could change.

In 1985 the Joint Meeting on Pesticide Residues (JMPR) examined two studies on carcinogenicity for mice and one study on chronic toxicity for rats. In one study on mice, Captafol caused increased cases of heart hemangioendotheliomas and small intestine tumors (Ito et. al., 1984). The number of heart hemangioendotheliomas increased with the doses, and some of them developed metastases. The number of cases for these two diseases was higher for male mice. In another study (Eissenlord and Wong, 1982) heart tumors were observed in both sex groups administered with high doses, and neoplastic lesions in the small intestine of male, but in none of the cases the increase was statistically significant. Both studies revealed, however, the manifestation of similar effects and biologically significant. In rats studies (Cox et. al. 1983), Captafol caused increased cases of neoplastic lesions in kidneys of male, in groups administered at high doses; lesions were as well observed in females administered at lower doses. The neoplastic nodes also increased significantly in the females liver of the high doses group. On the basis of these studies the Meeting concluded that Captafol is carcinogenic in mice and rats. Having taken into consideration the importance of the effects observed and that there was not demonstrated that there is a No Observed Effect Level, no ADI was established. Given the conclusion about the product carcinogenicity, the meeting considered unnecessary to examine other available data on the inocuicity of Captafol.

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

The product is subject to the Prior Informed Consent (PIC) procedure which requires that those hazardous substances and pesticides that are banned or severely restricted must not be exported, unless the importing country provides explicit consent. Those countries that do not consent such substances are obliged to prohibit national production of the substance for domestic uses. It is declared prohibited by the Government of Panama.

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

All registered formulations have been cancelled. It is considered hazardous waste subject to specialized control and treatment.

Date of entry into force of the final regulatory action: 01/01/2002