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MIS0102N - MIS0092N

Methylprednisolone hemisuccinate Edition: 08

Revision: 07
Date: 08/06/2017

Safety data sheet

SECTION 1. Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier

Product name METHYLPREDNISOLONE HEMISUCCINATE
Chemical name and synonym 4-[(11,17-dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl)oxy]-4-oxobutanoic acid
EC number 220-863-9
CAS number 2921-57-5
Registration Number 01-2120052366-58-0001

1.2. Relevant identified uses of the substance or mixture and uses advised against
Intended use Intermediate for the preparation of Pharmaceutical Active Ingredients (API).

1.3. Details of the supplier of the safety data sheet

Name NEWCHEM SPA
Full address via Roveggia 47
District and Country 37136 Verona (VR)
Italia
Tel. +39 045 504922
Fax +39 045 8201568
e-mail address of the competent person
responsible for the Safety Data Sheet segreteria@[Link]

1.4. Emergency telephone number

For urgent inquiries refer to +39 045 504922 (8 a.m. to 6.30 p.m., Mon-Fri).

SECTION 2. Hazards identification

2.1. Classification of the substance or mixture

The product is classified as hazardous pursuant to the provisions set forth in EC Regulation 1272/2008 (CLP) (and subsequent amendments and
supplements). The product thus requires a safety datasheet that complies with the provisions of EC Regulation 1907/2006 and subsequent amendments.
Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet.

Hazard classification and indication:

Reproductive toxicity, category 1B H360 May damage fertility or the unborn child.
Specific target organ toxicity - repeated exposure, category 2 H373 May cause damage to organs through prolonged or repeated
exposure.

2.2. Label elements

Hazard labelling pursuant to EC Regulation 1272/2008 (CLP) and subsequent amendments and supplements.

Hazard pictograms:

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Signal words: Danger

Hazard statements:

H360 May damage fertility or the unborn child.

H373 May cause damage to organs through prolonged or repeated exposure.
Restricted to professional users.

Precautionary statements:

P201 Obtain special instructions before use.

P202 Do not handle until all safety precautions have been read and understood.
P260 Do not breathe dust.
P280 Wear protective gloves / clothing and eye / face protection.
P308+P313 IF exposed or concerned: Get medical advice / attention.
P314 Get medical advice / attention if you feel unwell.

Contains: METHYLPREDNISOLONE HEMISUCCINATE

2.3. Other hazards

On the basis of available data, the product does not contain any PBT or vPvB in percentage greater than 0,1%.

SECTION 3. Composition/information on ingredients

3.1. Substances

Contains:

Identification Classification 1272/2008

(CLP)
METHYLPREDNISOLONE HEMISUCCINATE
CAS 2921-57-5 99.5% < - < 99.9% Repr. 1B H360, STOT RE 2
H373
EC 220-863-9
INDEX -
Reg. no. 01-2120052366-58-0001

The full wording of hazard (H) phrases is given in section 16 of the sheet.

SECTION 4. First aid measures

4.1. Description of first aid measures

EYES: Remove contact lenses, if present. Wash immediately with plenty of water for at least 15 minutes, opening the eyelids fully. If problem persists,
seek medical advice.

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SKIN: Remove contaminated clothing. Wash immediately with plenty of water. If irritation persists, get medical advice/attention. Wash contaminated
clothing before using it again.

INHALATION: Remove to open air. In the event of breathing difficulties, get medical advice/attention immediately.

INGESTION: Get medical advice/attention. Induce vomiting only if indicated by the doctor. Never give anything by mouth to an unconscious person,
unless authorised by a doctor.

4.2. Most important symptoms and effects, both acute and delayed

INGESTION: possible abdominal and stomach pain.

INHALATION EXPOSURE: possible mucous membranes and upper breathing intakes irritation.

CONTACT WITH SKIN: possible redness.

CONTACT WITH EYES: possible burning sensation, redness of conjunctiva.

4.3. Indication of any immediate medical attention and special treatment needed

Provide an emergency shower with face and eye wash station.

SECTION 5. Firefighting measures

5.1. Extinguishing media

SUITABLE EXTINGUISHING EQUIPMENT

The extinguishing equipment should be of the conventional kind: carbon dioxide, foam, powder and water spray.

UNSUITABLE EXTINGUISHING EQUIPMENT

None in particular.

5.2. Special hazards arising from the substance or mixture

HAZARDS CAUSED BY EXPOSURE IN THE EVENT OF FIRE

Do not breathe combustion products. The product is combustible and, when the powder is released into the air in sufficient concentrations and in the
presence of a source of ignition, it can create explosive mixtures with air. Fires may start or get worse by leakage of the solid product from the container,
when it reaches high temperatures or through contact with sources of ignition.
In case of thermal decomposition related to the effect of high temperatures may develop toxic substances for human healt: COx principally.

5.3. Advice for firefighters

GENERAL INFORMATION
Use jets of water to cool the containers to prevent product decomposition and the development of substances potentially hazardous for health. Always
wear full fire prevention gear. Collect extinguishing water to prevent it from draining into the sewer system. Dispose of contaminated water used for
extinction and the remains of the fire according to applicable regulations.

SPECIAL PROTECTIVE EQUIPMENT FOR FIRE-FIGHTERS

Normal fire fighting clothing i.e. fire kit (BS EN 469), gloves (BS EN 659) and boots (HO specification A29 and A30) in combination with self-contained
open circuit positive pressure compressed air breathing apparatus (BS EN 137).

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SECTION 6. Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

For non-emergency personnel

Alert personnel responsible for the management of such emergencies. Move away from the vicinity if you are not in possession of the personal protective
equipment listed in Section 8.

For emergency responders

Keep away all staff not adequately equipped to deal with the emergency. Wear suitable protective equipment (including personal protective equipment
referred to in section 8 of the safety data sheet) to prevent any contamination of skin, eyes and personal clothing. Block the leakage if to do so. Make
available to workers the area affected by the incident only occurred to appropriate cleansing. Ventilate the premises concerned by the accident.

6.2. Environmental precautions.

The product must not penetrate into the sewer system or come into contact with surface water or ground water.

6.3. Methods and material for containment and cleaning up.

Collect the leaked product and place it in containers for recovery or disposal. If the product is flammable, use explosion-proof equipment. If there are no
contraindications, use jets of water to eliminate product residues.
Make sure the leakage site is well aired. Evaluate the compatibility of the container to be used, by checking section 10. Contaminated material should be
disposed of in compliance with the provisions set forth in point 13.

6.4. Reference to other sections.

Any information on personal protection and disposal is given in sections 8 and 13.

SECTION 7. Handling and storage

7.1. Precautions for safe handling

Before handling the product, consult all the other sections of this material safety data sheet. Avoid leakage of the product into the environment. Do not
eat, drink or smoke during use. Remove any contaminated clothes and personal protective equipment before entering places in which people eat.

7.2. Conditions for safe storage, including any incompatibilities

Store only in the original container. Store the containers sealed, in a well ventilated place, away from direct sunlight. Keep containers away from any
incompatible materials, see section 10 for details.
Do not store above 25 °C. Store in a dry place.

7.3. Specific end use(s)

Information not available

SECTION 8. Exposure controls/personal protection

8.1. Control parameters.

During the risk assessment process, it is essential to take into consideration the ACGIH occupational exposure levels for inert particulate otherwise
classified (PNOC respirable fraction: 3 mg/m3; PNOC inhalable fraction: 10 mg/m3). For values above these limits, use a P type filter, whose class (1, 2
or 3) must be chosen according to the outcome of risk assessment.

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8.2. Exposure controls.

HAND PROTECTION
In the case of prolonged contact with the product, protect the hands with penetration-resistant work gloves (see standard EN 374).
Material : nitrile rubber, hypoallergenic
Thickness : not inferior to 0.12 mm

SKIN PROTECTION
Wear category II professional long-sleeved overalls and safety footwear (see Directive 89/686/EEC and standard EN ISO 20344). Wash body with soap
and water after removing protective clothing.

EYE PROTECTION
Wear airtight protective goggles (see standard EN 166).

RESPIRATORY PROTECTION
Use a type P1, P2 or P3 filtering facemask (see standard EN 149) or equivalent device, must be defined according to the outcome of risk assessment.

ENVIRONMENTAL EXPOSURE CONTROLS.

The emissions generated by manufacturing processes, including those generated by ventilation equipment, should be checked to ensure compliance with
environmental standards.

SECTION 9. Physical and chemical properties

9.1. Information on basic physical and chemical properties

[7][9]
Appearance Igroscopic crystalline powder.
Colour White or almost white.
Odour Not available
Odour threshold Not available
pH Not available
Melting point / freezing point Not available
[2][4]
Initial boiling point 689,6 °C a 760 mmHg (estimated).
Boiling range Not available
[2]
Flash point 230,7 °C (estimated).
Evaporation rate Not available
Flammability (solid, gas) Not available
Lower inflammability limit Not available
Upper inflammability limit Not available
Lower explosive limit Not available
Upper explosive limit Not available
Vapour pressure Not available
Vapour density Not available
3 [2][4]
Relative density 1,334 g/cm (estimated).
[5][6]
Solubility Very little soluble in water.
[5]
Partition coefficient: n-octanol/water 1,82
Auto-ignition temperature Not available
Decomposition temperature Not available
Viscosity Not available
Explosive properties Not available
Oxidising properties Not available

9.2. Other information

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Molecular weight. 474,54 g/mol

Solubility in organic solvent Slightly soluble in acetone and dehydrated ethanol. It dissolves in dilute solutions of alkali
[6]
hydroxides.
[2]
Index of refraction 1,593

SECTION 10. Stability and reactivity

10.1. Reactivity

There are no particular risks of reaction with other substances in normal conditions of use.

10.2. Chemical stability

The product is stable in normal conditions of use and storage.

10.3. Possibility of hazardous reactions

The powders are potentially explosive when mixed with air.

10.4. Conditions to avoid

Avoid exposure to: air, heat, light, moisture.

10.5. Incompatible materials

Avoid contact with: strong oxidising agents.

10.6. Hazardous decomposition products

In case of thermal decomposition related to the effect of high temperatures may develop toxic substances for human healt: COx principally.

SECTION 11. Toxicological information

11.1. Information on toxicological effects

In the absence of experimental toxicological data on the product itself, the possible health hazards of the product were evaluated based on the properties
of the substances contained, according to the criteria established by the relevant regulations for the classification. Therefore, consider the concentration
of each hazardous substances possibly mentioned in sect. 3, to assess toxicological effects resulting from exposure to the product.

ACUTE TOXICITY
Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.
[7]
LD50 (Oral) - Rat: > 2000 mg/Kg

SKIN CORROSION / IRRITATION.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.

SERIOUS EYE DAMAGE / IRRITATION.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and

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subsequent amendments, the product is not classified for this hazard class.

RESPIRATORY OR SKIN SENSITISATION.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.

GERM CELL MUTAGENICITY.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.
[6]
Methylprednisolone showed no evidence of mutagenicity in the DNA damage/alkaline elution assay.

CARCINOGENICITY.
Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.
[6]
Methylprednisolone was negative for carcinogenicity in the DNA-cell-binding (DCB) assay.

REPRODUCTIVE TOXICITY.
Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is classified for this hazard class as Repr.1B H360.
[7]
May damage fertility or the unborn child, specific effect: development .
Methylprednisolone administered intravenously to pregnant rats at doses of 0.09, 0.9 and 27 mg/kg/day resulted in decreased maternal weight, fetal
growth retardation, increased skeletal anomalies, high incidence of cleft palate, and low neonatal body weight in the high dose group. High frequencies of
fetal death and variety of central nervous system and skeletal anomalies were reported in the offspring of pregnant rabbits treated with
[6]
methylprednisolone in doses less than those used in humans.

STOT - SINGLE EXPOSURE.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.

STOT - REPEATED EXPOSURE.

Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is classified for this hazard class as STOT RE 2 H373.

ASPIRATION HAZARD.
Based on the assessment of the classification of the substance and classification provisions of Annex I, Part 3 of the reg. (EC) 1272/2008 and
subsequent amendments, the product is not classified for this hazard class.

Symptoms related to the physical, chemical and toxicological characteristics

Most studies have concluded that therapeutic use of corticosteroids by pregnant women does not cause adverse effects on the fetus. A small increase in
cleft palate was seen in some human studies. One study of women receiving 10 mg/day of prednisone throughout pregnancy had a statistically significant
decrease in the birth weight of term infants. Infants born to mothers who received substantial doses of corticosteroids during pregnancy should be
observed for signs of hypoadrenalism. The incidence of adverse effects from the therapeutic use of corticosteroids increases with dose and duration of
exposure; effects are rare with administration of less than three weeks. The mineralocorticoid actions of this material may cause disruption of fluid and
electrolyte imbalance, causing swelling, increased blood pressure, confusion, lightheadedness, nausea, vomiting, numbness, and tremors. Glucocorticoid
effects may include bone fractures, back pain, joint pain or stiffness, weakness, high blood pressure, increased appetite, infection, delayed wound
healing, thinning skin, bruising, increased hair growth, acne, redistribution of body fat, menstrual irregularities, impotence, headache, increased sweating,
[6][8]
eye pain, change in vision, and mental or behavioral changes.

Information on likely routes of exposure

The main routes of exposure are inhalation, ingestion, skin contact, eye contact.

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SECTION 12. Ecological information

12.1. Toxicity

Information not available

12.2. Persistence and degradability

Information not available

12.3. Bioaccumulative potential

Information not available

12.4. Mobility in soil

Information not available

12.5. Results of PBT and vPvB assessment

On the basis of available data, the product does not contain any PBT or vPvB in percentage greater than 0,1%.

12.6. Other adverse effects

Information not available

SECTION 13. Disposal considerations

13.1. Waste treatment methods

Waste are generated during:

emission controls: filters of the local ventilation.
maintenance: solvent (and rags with solvent) used for the cleaning of the equipments.
use: empty containers.
Filters, solvent and rags are collected and disposed. They don’t need particular treatment.
The hazard level of waste containing this product should be evaluated according to applicable regulations.
Disposal must be performed through an authorised waste management firm, in compliance with national and local regulations.

CONTAMINATED PACKAGING
Contaminated packaging must be recovered or disposed of in compliance with national waste management regulations.

SECTION 14. Transport information

The product is not dangerous under current provisions of the Code of International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID), of
the International Maritime Dangerous Goods Code (IMDG), and of the International Air Transport Association (IATA) regulations.

14.1. UN number

Not applicable

14.2. UN proper shipping name

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Not applicable

14.3. Transport hazard class(es)

Not applicable

14.4. Packing group

Not applicable

14.5. Environmental hazards

Not applicable

14.6. Special precautions for user

Not applicable

14.7. Transport in bulk according to Annex II of Marpol and the IBC Code

Information not relevant

SECTION 15. Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture

Seveso Category - Directive 2012/18/EC: None

Restrictions relating to the product or contained substances pursuant to Annex XVII to EC Regulation 1907/2006

None

Substances in Candidate List (Art. 59 REACH)

On the basis of available data, the product does not contain any SVHC in percentage greater than 0,1%.

Substances subject to authorisarion (Annex XIV REACH)

None

Substances subject to exportation reporting pursuant to (EC) Reg. 649/2012:

None

Substances subject to the Rotterdam Convention:

None

Substances subject to the Stockholm Convention:

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None

Healthcare controls

Workers exposed to this chemical agent must not undergo health checks, provided that available risk-assessment data prove that the risks related to the
workers' health and safety are modest and that the 98/24/EC directive is respected.

German regulation on the classification of substances hazardous to water (VwVwS 2005)

15.2. Chemical safety assessment

No chemical safety assessment has been processed for the mixture and the substances it contains.

SECTION 16. Other information

Revisions:
- Edition n. 08 dated 08/06/2017 (General revision of document – Inclusion of registration number)
- Revision n. 07

Text of hazard (H) indications mentioned in section 2-3 of the sheet:

Repr. 1B Reproductive toxicity, category 1B

STOT RE 2 Specific target organ toxicity - repeated exposure, category 2
H360 May damage fertility or the unborn child.
H373 May cause damage to organs through prolonged or repeated exposure.

LEGEND:
- ADR: European Agreement concerning the carriage of Dangerous goods by Road
- CAS NUMBER: Chemical Abstract Service Number
- CE50: Effective concentration (required to induce a 50% effect)
- CE NUMBER: Identifier in ESIS (European archive of existing substances)
- CLP: EC Regulation 1272/2008
- DNEL: Derived No Effect Level
- EmS: Emergency Schedule
- GHS: Globally Harmonized System of classification and labeling of chemicals
- IATA DGR: International Air Transport Association Dangerous Goods Regulation
- IC50: Immobilization Concentration 50%
- IMDG: International Maritime Code for dangerous goods
- IMO: International Maritime Organization
- INDEX NUMBER: Identifier in Annex VI of CLP
- LC50: Lethal Concentration 50%
- LD50: Lethal dose 50%
- OEL: Occupational Exposure Level
- PBT: Persistent bioaccumulative and toxic as REACH Regulation
- PEC: Predicted environmental Concentration
- PEL: Predicted exposure level
- PNEC: Predicted no effect concentration
- REACH: EC Regulation 1907/2006
- RID: Regulation concerning the international transport of dangerous goods by train
- TLV: Threshold Limit Value
- TLV CEILING: Concentration that should not be exceeded during any time of occupational exposure.
- TWA STEL: Short-term exposure limit
- TWA: Time-weighted average exposure limit
- VOC: Volatile organic Compounds
- vPvB: Very Persistent and very Bioaccumulative as for REACH Regulation
- WGK: Water hazard classes (German).

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GENERAL BIBLIOGRAPHY
1. Regulation (EU) 1907/2006 (REACH) of the European Parliament
2. Regulation (EC) 1272/2008 (CLP) of the European Parliament
3. Regulation (EU) 790/2009 (I Atp. CLP) of the European Parliament
4. Regulation (EU) 2015/830 of the European Parliament
5. Regulation (EU) 286/2011 (II Atp. CLP) of the European Parliament
6. Regulation (EU) 618/2012 (III Atp. CLP) of the European Parliament
7. Regulation (EU) 487/2013 (IV Atp. CLP) of the European Parliament
8. Regulation (EU) 944/2013 (V Atp. CLP) of the European Parliament
9. Regulation (EU) 605/2014 (VI Atp. CLP) of the European Parliament
10. Regulation (EU) 2015/1221 (VII Atp. CLP) of the European Parliament
11. Regulation (EU) 2016/918 (VIII Atp. CLP) of the European Parliament
- The Merck Index. - 10th Edition
- Handling Chemical Safety
- INRS - Fiche Toxicologique (toxicological sheet)
- Patty - Industrial Hygiene and Toxicology
- N.I. Sax - Dangerous properties of Industrial Materials-7, 1989 Edition
- IFA GESTIS website
- ECHA website
- Database of SDS models for chemicals - Ministry of Health and ISS (Istituto Superiore di Sanità) – Italy

[1]ChemIDplus: [Link]
[2] ChemSpider: [Link]
[3]PubChem: [Link]
[4]Scifinder: [Link]
[5]EDQM: [Link]
[6] MSDS USP: [Link]
[7]ECHA: [Link]
[8]Torrinomedica: [Link]
[9]Internal data Newchem

Note for users:

The information contained in the present sheet are based on our own knowledge on the date of the last version. Users must verify the suitability and
thoroughness of provided information according to each specific use of the product.
This document must not be regarded as a guarantee on any specific product property.
The use of this product is not subject to our direct control; therefore, users must, under their own responsibility, comply with the current health and safety
laws and regulations. The producer is relieved from any liability arising from improper uses.
Provide appointed staff with adequate training on how to use chemical products.

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