General Information
Revision date
2017-01-12
Product name
OXACILLIN SODIUM STERILE MONOHYDRATE
Substance name
is not subject to registration under REACH for number, if given their use
Product Synonyms
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-6- (if available)
Chemical name
Penicillins
CAS No.
7240-38-2
REACH No
is
1.2.1 Relevant identified uses
Active ingredient addressed to a professional use in pharmaceutical
supplier name
Fresenius Kabi iPSUM S.r.l
Emergency telephone
Fresenius Kabi iPSUM S.r.l
Icons in SDS
Company Information
company name
Fresenius Kabi iPSUM S.r.l
e-mail address of the competent person responsible for the Safety Data Sheet
mi-italy@fresenius-kabi.com, mg-italy@fresenius-kabi.com, vd-italy@fresenius-kabi.com, pz-italy@fresenius-kabi.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H317, H334
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
2.1 Classification of the substance or mixture
Classification of substance/mixture according to Regulation (EC) No 1272/2008
Hazard categories
Class code and Respiratory or skin Resp. Sens. 1 H334 May cause allergy or sensitization asthma symptoms or breathing difficulties if inhaled. Respiratory or skin Skin. Sens. 1 H317 May cause an allergic sensitization skin reaction. Main adverse effects Physico-chemical The substance/mixture can form explosive mixtures, under certain effects conditions. Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture, and any source of ignition, i.e. flame or spark, may cause fire or explosion. In case of fire, the substance/mixture emits toxic fumes.
Potential health effects
Ingestion: may cause heartburn and abdominal pain. Inhalation exposure: may cause upper respiratory tract irritation. Contact with skin: may cause irritation. Contact with eyes: may cause irritation. Sensitization: may cause sensitization by inhalation and skin contact. People who are allergic to beta – lactam (penicillin, cephalosporin, griseofulvin, penicillamine) should avoid exposure to this substance/mixture. Adverse drug reactions such as anaphylactic shock, asthma, rash or other phenomena may occur. [1]
Environmental effects
Not known. See also sections from 9 to 12.
2.2 Label elements
Labelling according to Regulation (EC) No 1272/2008
Hazard pictograms
Class code and
Precautionary statements
hazard category Resp. Sens. 1 H334 P261 P280 P362 P363 P501 P302 + P352 P333 + P313 GHS08 – Danger P342 + P311 Skin. Sens. 1 H317 P261 P280 P362 P363 P501 P302 + P352 P333 + P313 P342 + P311 For the full text of Hazard statement and Precautionary statements see Section 16.
2.3 Other hazards
The substance/mixture satisfies the PBT criteria
PBT Substances
Yes No
vPvB Substances
Yes No
Health hazards
Ingestion: may cause heartburn and abdominal pain. Inhalation exposure: may cause upper respiratory tract irritation. Contact with skin: may cause irritation. Contact with eyes: may cause irritation. Sensitization: may cause sensitization by inhalation and skin contact. People who are allergic to beta – lactam (penicillin, cephalosporin, griseofulvin, penicillamine) should avoid exposure to this substance/mixture. Adverse drug reactions such as anaphylactic shock, asthma, rash or other phenomena may occur. [1]
Environmental hazards
Not known. Physico-chemical The substance/mixture can form explosive mixtures, under certain effects conditions. Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture, and any source of ignition, i.e. flame or spark, may cause fire or explosion. In case of fire, the substance/mixture emits toxic fumes. Specific effects Not known
