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Macrogol-35-Glycerolrizinoleat: Material Safety Data Sheet

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60 views

Macrogol-35-Glycerolrizinoleat: Material Safety Data Sheet

Uploaded by

Achmad Latief
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 4

Material Safety Data Sheet

Page 1 of 4 according to Regulation (EC) No.


1907/2006 (REACH)

Macrogol-35-Glycerol-Rizinoleat
Print Date 26.11.2018
Revision Date 26.11.2018

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


· Informations to product No. 3262
· Product name:
Macrogol-35-Glycerolrizinoleat
Cremophor ® EL Neu: Kolliphor ® EL

· Supplier of the Product / responsible Company:


Caesar & Loretz GmbH
Herderstr. 31
40721 Hilden
Tel.: 02103/4994-0
Fax: 02103/32360
e-mail: [email protected]
· Emergency telephone:
Giftinformationszentrum Mainz
Langenbeckstr. 1, 55131 Mainz
Tel.: 06131/19240

· Relevant identified uses of the substance or mixture and uses advised against:
No further relevant information available.
· Application of the substance / mixture:
Ingredient for pharmaceutical drugs or active pharmaceutical ingredient.

2 Hazards identification
· Hazard classification: The substance is not classified as dangerous according to European Union
legislation.

2 Composition / information on ingredients


· Chemical characterization:
CAS-No. Substance name
61791-12-6 Rizinus oil ethoxylate
· EINECS-No.: 500-151-7
· REACH Reg. No.: 01-2119958762-26-0000
· INCI-Name: PEG-35-Castor Oil

4 First aid measures


· After skin contact: Take off contaminated clothes and shoes, wash immediately with plenty of water
and soap.
· After eye contact: Rinse out with plenty of water with the eyelid wide open. Call in ophthalmologist.
· After swallowing: Rinse mouth immediately. Drink plenty of water.

Page 1 of 4
Material Safety Data Sheet
Page 2 of 4 according to Regulation (EC) No.
1907/2006 (REACH)

Macrogol-35-Glycerol-Rizinoleat
Print Date 26.11.2018
Revision Date 26.11.2018

5 Fire-fighting measures
· Suitable extinguishing media: All regular extinguishing media can be used. Select fire fighting
measures suitable to surrounding environment.
· Specific hazards during fire fighting: Combustible. In case of fire dangerous vapours/gases can
be generated: Smoke gases.
· Special protective equipment for fire-fighters: Suitable protective clothes and respiratory
protection.
· Additional information: Prevent fire extinguishing water from contaminating surface water, the
ground water system or soil. Residues must be deposited according to local regulations.

6 Accidental release measures


· Personal protective measures: Avoid contact with substance.
· Environmental protective measures: Prevent from leaking into sewage water, ground water
system or surface waters.
· Methods for cleaning: Absorb with liquid-binding material: Sand, silica gel, acid binder, universal
binder, saw dust. Dispose according to chapter 13 of this MSDS.

7 Handling and storage


· Handling: No special requirements.
· Advice on safe handling: No special measures required.
· Informations to fire or explosion protection: No special measures required.
· Storage:
· Requirements for storage areas and containers: Keep container tightly closed. Kühl und trocken.
Store below 25 °C
· Advices on common storage: Not required.
· Additional informations to storage conditions: none

8 Exposure controls / personal protective equipment


· Personal protective equipment:
· General protective and hygiene measures:
The usual precaution measures during handling of chemicals are to observe.
· Respiratory protection: Not required.
· Hand protection: Protection gloves of rubber
· Eye protection: Safety glasses

9 Physical and chemical properties


· Form: liquid
· Colour: light yellow
· Odour: faint odour
· Melting point / melting range: 4 °C
· Boiling point / boiling range: > 100 °C
· Flash point: 257 ° C DIN-ISO 2592
· Ignition temperature: 405 °C DIN 51794

Page 2 of 4
Material Safety Data Sheet
Page 3 of 4 according to Regulation (EC) No.
1907/2006 (REACH)

Macrogol-35-Glycerol-Rizinoleat
Print Date 26.11.2018
Revision Date 26.11.2018

· Density: (25 °C) 1,05-1,06 g/cm³


· Solubility in / Miscibility with
· Water at 20 °C 100 g/l
· pH-range: (100 g/l, 20 °C) 6 – 8
· Viscosity:
· dynamic: (25 °C) 600-800 mPa*s
· thermical decomposition: ca. 300 °C

10 Stability and reactivity


· Thermical decomposition / conditions to avoid: Avoid strong heating. Decomposition above
300°C.
· Materials to avoid: Strong oxidants.
· Hazardous reactions: No hazardous reactions known.
· Hazardous decomposition products: none.

11 Toxicological information
· Acute toxicity: After single oral / dermal / inhalative exposition practically not toxic.
LD50 Rat (oral): > 6.400 mg/kg (BASF-Test)
Rat (inhalativ): 8 h (IRT)
Inhalation risk test (IRT): no mortality within 8 hours in animal experiments. Inhalation of saturated
atmosphere causes no acute danger.
LD50 Rat (dermal): > 5.000 mg/kg (BASF-Test)
· Irritant effect
Not irritant on skin and eyes.
Primary skin irritation Rabbit: Not irritant. (BASF-Test)
Primary irritations of mucous membranes Rabbit: Not irritant. (BASF-Test)
· Sensitization
No sensitization in animal experiments (guinea pig)
· Mutagenity
No mutagenity observed in several tests on bacteria and mammal cell cultures and mammals.
· Reproductive toxicity
In animal experiments no indication for reproductive toxicity observed.
· Teratogenity
In animal experiments no indication for teratogenity observed.

12 Ecological information
· Ecotoxical effects:
Not acute harmful for water organisms. In sewage plants disturbance of the activity of activated sludge
is not likely
Fish toxicity:
LC50 (48 h) 448 mg/l, Leuciscus idus (DIN 38412 Teil 15, static)
Aquatic invertebrates:
EC50 (48 h) > 100 mg/l, Daphnia magna (OECD-Guideline 202, Teil 1, static)
Water plants:
EC50 (72 h) > 93 mg/l (growth rate), Desmodesmus subspicatus (OECD-Guideline 201, static)
Micro organisms / Effect on activated sludge:

Page 3 of 4
Material Safety Data Sheet
Page 4 of 4 according to Regulation (EC) No.
1907/2006 (REACH)

Macrogol-35-Glycerol-Rizinoleat
Print Date 26.11.2018
Revision Date 26.11.2018

EC20 (30 min) > 1.000 mg/l, (DIN EN ISO 8192-OECD 209-88/302/EWG,T. C, aerob)
· Persistence and degradability:
Not readily biodegradable. (OECD-criteria). Slow biodegradation.
Elimination: 90 - 100 % DOC-reduction (21 d) (OECD-Guideline 302 B).
· Water hazard class: 1 (self classification): slightly hazardous for water.

13 Disposal considerations
· Product:
· Recommendation: Disposal according to local regulations as pharmaceutical waste.
· Empty contaminated packaging:
· Recommendation: Disposal according to the local regulations.

14 Transport informations
· Land transport according to ADR:
Not classified as dangerous in the meaning of transport regulations.

15 Regulatory information
· Labelling according to actual legislation (GHS, Globally Harmonized System of Classification and
Labelling of Chemicals):
The product does not need to be labelled according to GHS-regulations.
· National regulations (Germany):
· Water hazard class: see chapter 12
· Storage class TRGS 510: 10
· VbF class: -

16 Other Information
The information provided in this MSDS is correct to the best of our knowledge at the date of edition.

· Reason for last revision: Adjustment to regulation (EC) 1907/2006 (REACH) and GHS-labelling
system.

Page 4 of 4

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