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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2013-1345

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 12110101

Nom du titulaire (nom légal complet, aucune abbréviation): Nufarm Agriculture Inc.

Adresse: 5507 1st Street SE

Ville: Calgary

État: AB

Pays: Canada

Code postal /Zip: T2H 1H9

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez l'humain

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

01-NOV-12

5. Lieu de l'incident.

Pays: UNITED STATES

État: OHIO

6. Date de la première observation de l'incident.

Inconnu

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 228 366

Nom du produit: Razor Pro Herbicide

  • Matière active
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Garantie/concentration 41 %

7. b) Type de formulation.

Liquide

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Inconnu

9. Dose d'application.

10. Site d'application (choisir tout ce qui s'applique).

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Inconnu

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Professionnel de la santé

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

  • Système respiratoire
    • Symptôme - Congestion pulmonaire
    • Symptôme - Toux
  • Peau
    • Symptôme - Ictère
  • Foie
    • Symptôme - Hépatique
  • Système cardiovasculaire
    • Symptôme - Arrêt cardiaque
  • General
    • Symptôme - Mort

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Oui

6. a) Est-ce que la personne a été hospitalisée?

Oui

6. b) Pendant combien de temps?

5

Hour(s) / Heure(s)

7. Scénario d'exposition

Professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Inconnu

10. Voie(s) d'exposition.

Inconnu

11.Durée de l'exposition?

Unknown / Inconnu

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

Unknown / Inconnu

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

1 1 2012 10 34 28 AM WT from Chemtrec (number) Chemtrec case # (number) Chemtrec employee indicates he has a doctor on the line that is from (name) County medical examiner s office in (city). The doctor is investigating a human death that took place in (month). The doctor is transferred. Razor Pro Herbicide No label or EPA reg is available; the doctor has the MSDS History: The doctor describes a (age) YO male landscaper who began to feel punky around Labor day. Symptoms were primarily respiratory such as a cough. Over the next week he felt progressively more ill and decided to stay home from work. On the 13th (09/13/12) he is sitting home watching television and went into cardiac arrest. He was transported to the hospital and resuscitated. He died 5 6 hours later. The autopsy was done and there are some changes associated with poor perfusion following the cardiac arrest (hypoxic encephalopathy). The notable change found on autopsy was liver failure or necrosis that appears fulminant. The family had mentioned the patient had switched the herbicide protocols he used at work to include the product. The caller indicates he is doing due diligence for the family. He had spoken to his staff toxicologist and they could find no information that indicated this may be seen with this AI. Chemtrec (C) Exposure would have been dermal or respiratory I assume, there was no report of ingestion? Attending Doctor (AD) correct C The skin is a pretty effective barrier to absorption here and the respiratory route is not one where generalized harm is typically seen. We would primarily expect an irritant effect here. Even following ingestion the AI is fairly well tolerated. There is report in our literature that liver effects can be seen, but that is not qualified. I am unsure what this is referring to. AD I see that. C Since you are asking for information beyond my scope I can offer a consult with our medical toxicologist if you would like The caller accepted 11 1 2012 10 54 48 AM PROSAR call out Responding doctor (RD) Prosar Case # (number) Conveyed history and conferenced with AD RD Do we have an idea when the time frame of the switch over to the glyphosate herbicide took place AD No, when they had heard he was in a nursery they had focused on the OP angle. RD It s not a OP, did they do a cholinesterase assay AD They did not, I did it was 40% normal but it was after cardiac arrest and resuscitation RD Was it RBC or serum AD I think it was whole blood. Enzymes do a lot of funny things after cardiac arrest and resuscitation. RD Well yes we can have hemolysis. AD He basically had a cough and nasal secretions, became progressively more and more fatigued and this fits with a guy going into liver failure. He is jaundiced. He hits the door with pretty impressive liver necrosis that is mostly centralobular. Expanding out but there is broad geographic areas of necrosis. He did not take medications such as acetaminophen. RD There has been described microvascular steatosis in the hepatocytes, centralobular. In fact there was just publication about this sept 2012 American Journal of Forensic Medicine Vol 33 244 247 in association with a glyphosate ingestion . AD I have no reason to suspect this type of exposure. The route is either cutaneous or inhalation and he was away from it (work) for a week. RD The AI is absorbed less than 2 % dermally Inhalation it is not very volatile, you do not want it to be volatile as a herbicide Most of it is irritation signs mucosal , eyes burning nasal burning AD He has a cough initially which he attributes to allergies RD Any lung injury AD Shock lung stuff RD Liver is not typically a target organ for glyphosate per say. Plus the mechanism you describe is unusual by the routes you describe. If he was drinking it this may be different. Especially outdoors. AD I m not ringing the bell on causation, more coincidental. About 10 15 %

À être déterminé par le titulaire

14. Classification selon la gravité.

Mort

15. Donner des renseignements additionnels ici.

acute fulminate liver things we see are left etiology unknown RD Ask the family about supplements he may be taking AD He is not a medicine guy according to his family RD Consider ergogenic drugs, anabolic steroids. Look for steatosis. The kidneys were fine? AD Acute injury is present from the period of poor perfusion RD The mechanism and route are not consistent of the expectation of glyphosate AD Fair enough Call closed, case # and call back # provided