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Greenstone LLC
100 Route 206 North
Peapack, NJ 07977
800-435-7095
Not applicable
None
Angiotensin converting enzyme inhibitor
Antihypertensive
2. HAZARDS IDENTIFICATION
Appearance:
Signal Word:
Statement of Hazard:
Long Term:
Animal studies have shown a potential to cause adverse effects on the fetus. In humans, the
use of drugs in this class (ACE inhibitors) can cause fetal and neonatal toxicity, including low
blood pressure and kidney failure, when they are taken during the second and third trimesters
of pregnancy.
Adverse effects most commonly reported in clinical use include dizziness, nausea, headache,
anxiety, drowsiness. Due to intended use, dangerous lowering of blood pressure can occur.
Toxic to Reproduction: Category 3
EU Hazard Symbols:
EU Risk Phrases:
Australian Hazard Classification
(NOHSC):
Note:
This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediates
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.
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PZ01009
3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous
Ingredient
Lisinopril
Starch, pregelatinized
Ferric oxide red
Corn Starch
Ferric oxide yellow
Magnesium stearate
CAS Number
83915-83-7
9005-25-8
1309-37-1
9005-25-8
51274-00-1
557-04-0
%
2-15
*
*
*
*
*
Ingredient
Dibasic Potassium Phosphate
Mannitol
CAS Number
7758-11-4
69-65-8
%
*
*
Additional Information:
For the full text of the R phrases mentioned in this Section, see Section 16
Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Skin Contact:
Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.
Ingestion:
Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation:
Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information.
Carbon monoxide, carbon dioxide, and oxides of nitrogen may be generated in a fire.
During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus.
Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.
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PZ01009
Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.
Storage Conditions:
Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken,
avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, use
appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin
after removal of PPE. Review and implement appropriate technical and procedural waste water
and waste disposal measures to prevent occupational exposure or environmental releases.
Potential points of process emissions of this material to the atmosphere should be controlled
with dust collectors, HEPA filtration systems or other equivalent controls. Releases to the
environment should be avoided.
Store as directed by product packaging.
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PZ01009
10 mg/m3
10 mg/m3
10 mg/m3
10.0 mg/m3
4.0 mg/m3
10 mg/m3
5 mg/m3
10 mg/m3
4 mg/m3
15 mg/m3
10 mg/m3
4 mg/m3
10 mg/m3
5 mg/m3
5 mg/m3
10 mg/m3
5 mg/m3
10 mg/m3
2 ppm
5 mg/m3
5.0 mg/m3
3.5 mg/m3
3.5 mg/m3
5 mg/m3
5 mg/m3
10 mg/m3
6 mg/m3
5 mg/m3
10 mg/m3
4 mg/m3
3.5 mg/m3
10 mg/m3
5 mg/m3
5 mg/m3
5 mg/m3
1.5 mg/m3
5 mg/m3
3.5 mg/m3
10 mg/m3
10 mg/m3
10 mg/m3
10.0 mg/m3
4.0 mg/m3
10 mg/m3
5 mg/m3
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PZ01009
10 mg/m3
5 mg/m3
5 mg/m3
Engineering Controls:
Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne
contamination levels below the exposure limits listed above in this section.
Refer to applicable national standards and regulations in the selection and use of personal
protective equipment (PPE).
Impervious gloves are recommended if skin contact with drug product is possible and for bulk
processing operations.
Wear safety glasses or goggles if eye contact is possible.
Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.
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.
Hands:
Eyes:
Skin:
Respiratory protection:
Tablet
Mixture
Solubility:
Partition Coefficient
(Calculated - Log Pow/Log Kow):
Partition Coefficient
(Calculated; pH 7.4 - Log D):
Soluble: Water
1.18 (Lisinopril)
Color:
Molecular Weight:
-1.41 (Lisinopril)
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PZ01009
The information included in this section describes the potential hazards of the individual
ingredients.
None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
Environmental Overview:
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PZ01009
LC50
96 Hours
Dispose of waste in accordance with all applicable laws and regulations. Member State
specific and Community specific provisions must be considered. Considering the relevant
known environmental and human health hazards of the material, review and implement
appropriate technical and procedural waste water and waste disposal measures to prevent
occupational exposure and environmental release. It is recommended that waste minimization
be practiced. The best available technology should be utilized to prevent environmental
releases. This may include destructive techniques for waste and wastewater.
Xn
Toxic to Reproduction: Category 3
EU Risk Phrases:
R63 - Possible risk of harm to the unborn child.
EU Safety Phrases:
S22 - Do not breathe dust.
S36/37 - Wear suitable protective clothing and gloves.
S53 - Avoid exposure - obtain special instructions before use.
OSHA Label:
WARNING
Suspected of damaging the unborn child.
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PZ01009
Present
Present
231-834-5
Present
Present
Present
232-679-6
Present
Present
215-168-2
Present
Present
Present
232-679-6
Present
Present
Present
200-711-8
Present
Present
257-098-5
Magnesium stearate
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Present
Present
209-150-3
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PZ01009
Prepared by:
It is believed that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is
without a warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known
information at this time
End of Safety Data Sheet
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PZ01009