Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

VALPROIC ACID, SEMISODIUM SALT

NFPA

PRODUCT USE

Anticonvulsant; antiepileptic. Used in the treatment of various forms of epilepsy
including petit mal and in infantile spasms. Given as the acid or sodium salt. The action
of valproic acid may involve a modification of the behaviour of gamma- aminobutyric acid
(GABA) in the brain. Anticonvulsant; antiepileptic. Used in the treatment of various forms
of epilepsy including petit mal and in infantile spasms. Given as the acid or sodium salt.
The action of valproic acid semisodium may involve a modification of the behaviour of
gamma- aminobutyric acid (GABA) in the brain. Medicine

SYNONYMS

C16-H21-O4.Na, "pentanoic acid, 2-propyl, sodium salt (2:1)", "pentanoic acid, 2-
propyl, sodium salt (2:1)", "aliphatic monocarboxylic acid (C6-28) light metal salt",
"sodium 2-propylpentanoate", "sodium 2-propylpentanoate", "2-propylpentanoic acid
semisodium salt", "2-propylpentanoic acid semisodium salt", "Divalproex sodium", Convulex,
DPA, Depakene, Depakine, "Depakote Depakote Cp", "Depakote Er", "Depakote Sprinkle
Dipropylacetic Acid", "Divalproex Sodium", Epilim, "Epival Ergenyl", Mylproin, "N-
dipropylacetic acid semisodium", "N-dipropylacetic acid semisodium", N-DPA, N-DPA,
"propylvaleric acid semisodium semisodium valproate", "valproate semisodiumValproic Acid
semisodium USP", "Valproic Acid", "semisodium USP24 anticonvulsant/ antiepileptic"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Although ingestion is not thought to produce harmful effects, the material may still be damaging to the health of the individual following ingestion, especially where pre-  existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, ingestion of insignificant quantities is not thought to be cause for concern.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material may produce foreign body irritation in certain individuals.  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.  

INHALED

  Inhalation may produce health damage*.  Inhalation of dusts, generated by the material during the course of normal handling, may be damaging to the health of the individual.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of dusts, or fume, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  

CHRONIC HEALTH EFFECTS

  Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray.  There is some evidence that human exposure to the material may result in developmental toxicity. This evidence is based on animal studies where effects have been observed in the absence of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not secondary non-specific consequences of the other toxic effects.  Several off-spring of eight pregnant women taking valproate as an  antiepileptic drug were deformed -  two babies had facial abnormalities  and one baby had a heart lesion.  Intraperitoneal administration to mice (340 mg/kg on days 6-18 of  gestation) produced a 30% incidence of neural tube defect in the cranial  region of embryos and a reduced head size  When the free acid was given by gavage to rats, 600 mg/kg was maternally  toxic and produced 100% embryonic resorption. At 400 mg/kg 52% of all  embryos were resorbed and 49% of survivors were malformed. Defects  included ectrodactyly, hydronephrosis, cardiovascular defects, hypoplastic  bladder, rib and vertebral defects. At 200 mg/kg, defects included  hydronephrosis, cardiovascular abnormalities and rib defects (primarily  wave ribs).