MATERIAL SAFETY DATA SHEET S E C T I O N 1 - I D E N T I F I C A T I O N O F P R O D U C T A N D C O M P A N Y Pfizer Inc Pfizer Animal Health 2 3 5 E a s t 4 2 n d S t r e e t N e w Y o r k, N Y 1 0 0 1 7 E m e r g e n c y t e l e p h o n e H o u r s o f o p e r a t i o n T e l e p h o n e T r a d e n a m e s V A L B A Z E N S U S P E N S I O N P r o d u c t N a m e A l b e n d a z o l e s u s p e n s i o n T h e r a p e u t i c u s e Anthelmintic D e s c r i p t i o n Odorless, white, smooth, uniform liquid suspension 1-866-531-8896 24 Hours 1-800-366-5288 S E C T I O N 2 - C O M P O S I T I O N Ingredient CAS Number Amount Albendazole* 54965-21-8 <12.0% Benzoic Acid* 65-85-0 Proprietary Glycerin* 56-81-5 Proprietary Magnesium aluminum silicate* 1327-43-1 Proprietary Polysorbate 80 - NF 9005-65-6 Proprietary Potassium sorbate* 590-00-1 Proprietary Simethicone 8050-81-5 Proprietary Sodium carboxymethyl cellulose USP 9004-32-4 Proprietary Sorbitan monolaurate 1338-39-2 Proprietary *Hazardous Note: Ingredient(s) indicated as hazardous have been assessed under US OSHA Hazard Communication Standard for workplace safety (29 CFR 1910.1200). S E C T I O N 3 - H A Z A R D S I D E N T I F I C A T I O N Signal word W A R N I N G! S t a t e m e n t s o f h a z a r d R E P R O D U C T I V E H A Z A R D M A Y C A U S E B L O O D, L I V E R, O R T E S T I C U L A R E F F E C T S E y e e f f e c t s Active ingredient is not an irritant (based on animal data). May cause irritation based on components. S k i n e f f e c t s Active ingredient is not a skin irritant (based on animal data). May cause irritation based on components. May cause allergic skin reaction based on components. Page 1 of 7
S E C T I O N 3 - H A Z A R D S I D E N T I F I C A T I O N... continued I n h a l a t i o n e f f e c t s An Occupational Exposure Limit has been established for one or more of the ingredients (see Section 8). I n g e s t i o n e f f e c t s See 'Statements of hazard', 'Known clinical effects', and/or 'Other potential health effects' in this section. K n o w n c l i n i c a l e f f e c t s Adverse effects seen in clinical use include gastrointestinal discomfort, dizziness, and headache. O t h e r p o t e n t i a l h e a l t h e f f e c t s While incidental administration to mothers during the first trimester of pregnancy was without adverse effects on offspring, albendazole has caused teratogenic effects in animals and is considered to be a reproductive hazard. N O T E : This document has been prepared in accordance with the US OSHA Hazard Communication Standard, which requires the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. If your workplace is regulated by OSHA, this document must be used as a part of a complete hazard-training program. S E C T I O N 4 - F I R S T A I D M E A S U R E S S k i n Remove clothing and wash affected skin with soap and water. If irritation occurs or persists, get medical attention. E y e s Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, get medical attention. Inhalation Remove to fresh air. If not breathing, give artificial respiration. Get medical attention. I n g e s t i o n Get medical attention. Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person. S E C T I O N 5 - F I R E F I G H T I N G M E A S U R E S General hazard Toxic or corrosive emissions may be given off in a fire. F i r e f i g h t i n g i n s t r u c t i o n s Wear approved positive pressure, self-contained breathing apparatus and full protective turn out gear. E x t i n g u i s h i n g m e d i a Use water, carbon dioxide, foam or dry chemical extinguishers. F l a s h p o i n t Not applicable H a z a r d o u s c o m b u s t i o n p r o d u c t s Not known Page 2 of 7
S E C T I O N 6 - A C C I D E N T A L R E L E A S E M E A S U R E S G e n e r a l Review Sections 3, 8 and 12 before proceeding with clean up. Small spill Use non-combustible absorbent material to wipe up spill and place in a sealed container for disposal. Clean spill area thoroughly. Prevent discharge to drains. L a r g e s p i l l Use appropriate containment to avoid environmental contamination. Collect spill with a non-combustible absorbent material and transfer to labeled container for disposal. Close container and move it to a secure holding area. S E C T I O N 7 - H A N D L I N G A N D S T O R A G E G e n e r a l h a n d l i n g Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and follow appropriate grounding and bonding procedures. Use only in a well-ventilated area. Avoid breathing dust, vapor or mist. S t o r a g e c o n d i t i o n s Avoid prolonged storage at elevated temperatures (greater than room temperature, approximately 20 degrees C). Keep in tightly closed containers or packages away from moisture. Protect from freezing. T e m p e r a t u r e r a n g e f o r s t o r a g e Store at room temperature 15-30 C (59-86 F) S E C T I O N 8 - E X P O S U R E C O N T R O L S / P E R S O N A L P R O T E C T I O N E x p o s u r e l i m i t s Compound Issuer Type OEL Albendazole Pfizer TWA-8 HR 0.8 mg/m³ Glycerin OSHA TWA-8 Hr 5 mg/m³ (respirable fraction) OSHA TWA-8 Hr 15 mg/m³ (total dust) ACGIH TWA-8 Hr 10 mg/m³ (mist) E x p o s u r e i n f o r m a t i o n The exposure limit(s) listed for solid components are only relevant if dust may be generated. M e a s u r e m e n t m e t h o d Albendazole: CAM-KAS-97-08 (contact Pfizer for additional details). V e n t i l a t i o n Engineering controls should be used as the primary means to control exposures. R e s p i r a t o r y p r o t e c t i o n If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. E y e p r o t e c t i o n Wear safety glasses with sideshields if eye contact is possible. Page 3 of 7
S E C T I O N 8 - E X P O S U R E C O N T R O L S / P E R S O N A L P R O T E C T I O N... continued S k i n p r o t e c t i o n Use protective clothing (uniforms, lab coats, disposable coveralls, etc.) in both production and laboratory areas. Wash hands and arms thoroughly after handling this material. H a n d p r o t e c t i o n Wear protective gloves to avoid routine skin contact. S E C T I O N 9 - P H Y S I C A L A N D C H E M I C A L P R O P E R T I E S Physical form Suspension C o l o r White O d o r Odorless M o l e c u l a r w e i g h t Mixture M o l e c u l a r f o r m u l a Mixture p H No data available B o i l i n g p o i n t Not applicable M e l t i n g p o i n t No data available D e n s i t y No data available V a p o r p r e s s u r e Not applicable W a t e r s o l u b i l i t y Soluble S o l v e n t s o l u b i l i t y No data available S E C T I O N 1 0 - S T A B I L I T Y A N D R E A C T I V I T Y R e a c t i v i t y Stable C o n d i t i o n s t o a v o i d Avoid extreme temperatures I n c o m p a t i b i l i t i e s None known H a z a r d o u s d e c o m p o s i t i o n p r o d u c t s H a z a r d o u s p o l y m e r i z a t i o n No data available Will not occur S E C T I O N 1 1 - T O X I C O L O G Y I N F O R M A T I O N T o x i c o l o g y s u m m a r y The information included in this section describes the potential hazards of the active ingredient, except where noted. Page 4 of 7
S E C T I O N 1 1 - T O X I C O L O G Y I N F O R M A T I O N... continued A c u t e t o x i c i t y Compound Type Route Species Dosage Albendazole LD 50 Oral Rat >1320 mg/kg LD 50 Oral Mouse >3000 mg/kg Irritation Dermal Rabbit 500mg:NEG Irritation Ocular Rabbit 100mg:NEG Glycerin Irritation Dermal Rabbit 500mg:MLD Irritation Ocular Rabbit 500mg:MLD E y e Some irritation may be expected based on components. See Acute toxicity table. S k i n Some irritation may be expected based on components. See Acute toxicity table. Inhalation No data available I n g e s t i o n See table above M u t a g e n i c i t y This material was not mutagenic in bacteria (Ames test) or animal cells (cell-mediated Chinese hamster ovary test). S e n s i t i z a t i o n Albendazole is not a sensitizer. Sensitization (allergic skin reaction) may occur, based on effects of individual components. S u b c h r o n i c e f f e c t s Oral administration of up to 1600 mg/kg/day to rats, mice, or dogs in studies of 4-weeks to six months in duration resulted in reduced hematological counts; liver, testes, adrenal and spleen effects; and significant mortality in rats and mice at 168 and 1600 mg/kg/day, respectively. C h r o n i c e f f e c t s / c a r c i n o g e n i c i t y In a two-year oral administration study in mice with doses up to 400 mg/kg/day, histopathologic changes in the testes of males and in the liver of males and females were noted at 400 and at both the 100 and 400 mg/kg/day dose levels, respectively. A two-generation feeding study was conducted in rats, with the second (F 1 ) generation receiving up to 20 mg/kg/day for 28 months. There were no effects noted in the first generation (F 0 ), however, reduced hematologic counts and effects on testes and liver were observed in the high-dose F 1 animals. C a r c i n o g e n s t a t u s None of the components of this formulation is listed as a carcinogen by IARC, NTP or OSHA. R e p r o d u c t i v e e f f e c t s Rat reproductive toxicity studies showed only minimal effects on male and female reproduction. T e r a t o g e n i c i t y Teratogenic effects (birth defects) and/or toxicity to developing offspring occurred in studies with rats, rabbits, sheep and swine at doses as low as 5 to 10 mg/kg. T a r g e t o r g a n s Hematological system, testes, liver Page 5 of 7
S E C T I O N 1 1 - T O X I C O L O G Y I N F O R M A T I O N... continued A t i n c r e a s e d r i s k f r o m e x p o s u r e This material produced developmental toxicity in studies with animals. Over exposure during pregnancy might have an adverse effect on developing offspring. Additional information FDA PREGNANCY CATEGORY C. Animal studies have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. S E C T I O N 1 2 - E C O L O G I C A L I N F O R M A T I O N E n v i r o n m e n t a l o v e r v i e w In the environment, the active ingredient in this formulation is expected to bind to soil or sediment and not persist. Harmful effects to aquatic organisms could occur. M o b i l i t y, p e r s i s t e n c e, and degradability: B i o a c c u m u l a t i o n a n d t o x i c i t y : The active ingredient in this formulation is expected to bind to soil, sediment, or with solids in a wastewater treatment facility and degrade rapidly when exposed to sunlight. [Half-life<1/2 day in sunlight.] Acute toxicity to aquatic organisms may occur. The active ingredient in this formulation has low potential to bioaccumulate and long-term adverse effects to aquatic organisms are not expected. See aquatic toxicity data, below. A q u a t i c t o x i c i t y Compound Type Species Dosage Glycerin LC50/96h Rainbow Trout 50-67 mg/l L o g P ( o c t a n o l / w a t e r p a r t i t i o n c o e f f i c i e n t ) A d s o r p t i o n C o e f f i c i e n t ( K o c ) 2.7 (albendazole) 7800-27500 (albendazole) S E C T I O N 1 3 - D I S P O S A L I N F O R M A T I O N D i s p o s a l p r o c e d u r e Incineration is the recommended method of disposal for this material. Observe all local and national regulations when disposing of this material. S E C T I O N 1 4 - T R A N S P O R T A T I O N I N F O R M A T I O N G e n e r a l s h i p p i n g i n s t r u c t i o n s Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. S E C T I O N 1 5 - R E G U L A T O R Y I N F O R M A T I O N E U C l a s s i f i c a t i o n Substance toxic to reproduction, Category 2 Page 6 of 7
S E C T I O N 1 5 - R E G U L A T O R Y I N F O R M A T I O N... continued E U L a b e l l i n g T E U L a b e l P i c t o g r a m ( s ) R i s k p h r a s e s R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed. R61 - May cause harm to the unborn child. S a f e t y p h r a s e s S53 - Avoid exposure - obtain special instructions before use. Canadian WHMIS Class D, Division 2, Subdivision A S E C T I O N 1 6 - O T H E R D i s c l a i m e r P f i z e r I n c b e l i e v e s t h a t t h e i n f o r m a t i o n c o n t a i n e d i n t h i s M a t e r i a l S a f e t y D a t a S h e e t i s a c c u r a t e, a n d w h i l e i t i s p r o v i d e d i n g o o d f a i t h, i t i s w i t h o u t a w a r r a n t y o f a n y k i n d, e x p r e s s e d o r i m p l i e d. Page 7 of 7