Kao Corporation

GLOBAL PRODUCT STRATEGY SAFETY SUMMARYAMPHITOL 55AB
This document is a high-level summary provides usage of chemical substances and safety
information to the general public. It is not intended to replace the Safety Data Sheet, which isavailable from suppliers and should be referred to for full details of recommended safety
procedures for each type of use. It is not intended to replace or supersede manufacturer’sinstructions and warnings for their consumer products containing this substance.

1. Substance Identity
Brand Name: AMPHITOL 55AB
Chemical Name: Cocamide propyl betaine (main component)
CAS Number: 61789-40-0 (main component)

2. Uses and Applications
AMPHITOL 55AB is an amphoteric surfactant. It is used as a foam solubilizer for quasi‐drugs
and cosmetics.

3. Physical/Chemical Properties
AMPHITOL 55AB has no identified physicochemical hazards.
Property

Value

Physical state

LiquidColour

Light yellow clear

Odour

Slightly characteristic odourpH

7 (1% solution)

Density

1.058 g/mL(77 °F )(25℃)
1.056 g/mL(86 °F ) (30℃)

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Freezing point

1.051 g/mL(104 °F ) (40℃)<20 ℃ ( <68 °F)

Boiling point
Flash point
Flammability

No information available
No information available
No information available

Explosive properties

No information available

Self – ignition temperature

No information available

Vapour pressure

No information available

Water solubility

SolubleOctanol-water partition coefficient (log Kow)

No information available
13 mPa･s ( 25 ℃) ( 77 °F)
12.2 mPa･s ( 30 ℃) ( 86 °F)
11 mPa･s ( 40 ℃) ( 104 °F)

Viscosity

4. Human Health Safety Assessment
Consumer: The exposure to AMPHITOL 55AB is at safe levels.
Worker: The repeated exposure of AMPHITOL 55AB does not cause any toxic effects.
Effect Assessment

ResultNo acute toxicity after oral/ dermal exposurein practical use.
The substance does not cause damage toany organs following single exposure.
Based on the available data, unlikely tocause skin irritation.
Undiluted substance causes serious eyedamage.
Based on the available data, unlikely tocause allergic skin reaction.
Unlikely to cause any toxic effects throughprolonged or repeated oral exposure inpractical use.
Based on the available data, unlikely tocause genetic defects.
Based on the available data, unlikely tocause cancer.
Based on the available data, unlikely to bedamaging to fertility or the unborn child.

Acute Toxicity
oral/ dermal

Irritationskin/ eyeSensitization
Toxicity after repeated exposure
Mutagenicity
Carcinogenicity
Toxicity for reproduction

5. Environmental Safety Assessment
The test results with fish, aquatic invertebrates and algae suggest that AMPHITOL 55AB could
cause a toxicity to aquatic organisms. It also could cause harmfulness to aquatic organisms
with long lasting effects. However, AMPHITOL 55AB is unlikely to persist in the environment

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because of showing the readily biodegradation. AMPHITOL 55AB does not bioaccumulate inthe food chain.
Effect Assessment

ResultAquatic Toxicity

Based on the available data, likely to cause a toxicity toaquatic organisms and harmful to aquatic life with long
lasting effects

Biodegradation

Readily biodegradable

PBT/ vPvB conclusion

Not persistent in the environment, not bioaccumulatingin organisms and not toxic nor very persistent and very
bioaccumulating

6. Exposure
Consumer
The consumer can come into contact with the substance in use of the quasi-drugs andcosmetic products, but the concentration of AMPHITOL 55AB in use is below the level which
would give rise harmful effects of concern. When it’s used as the recommended use,
consumer should always read product information before use and follow the label/ use
instructions.
Worker
The exposure can occur either in AMPHITOL 55AB manufacturing facilities or in the various
industrial facilities when AMPHITOL 55AB is used. Those workers in industrial operations
during maintenance, sampling, testing, or other procedures could be exposed with AMPHITOL
55AB. Only qualified and trained workers handle the undiluted substance. The manufacturing
facilities offer thorough training program for employees and appropriate work processes, aswell as safety equipment (goggles and gloves) in place to present an unnecessary exposure.
Safety showers and eye-wash stations are accessible nearby. Workers are required to be
trained in accordance with the safety measures in the Safety Data Sheet.
Environment
Since this substance is used extensively, it is discharged to waste water treatment plants fromindustrial sites such as manufacturing, preparation, handling, storage and use of thesubstance as well as from consumer households. However, the substance is readily
biodegradable, so that it is removed efficiently in waste water treatment plants. The substanceis biologically degraded in the surface water and is rapidly removed even if it is remainedslightly in the waste water. Hence, the chronic exposure to aquatic organisms of the substanceis unlikely to occur. Furthermore, the substance dose not accumulate in the food chain, so that
there is no concern of human exposure through environmental pathway.

7. Risk management recommendations
When you use the substance, make sure to be measured the adequate ventilation. Always
use appropriate chemical-resistant gloves to protect your hands and skin and always wear
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eye protection equipment. Do not eat, drink or smoke where the substance is handled,processed or stored. Wash hands and skin after contact with the substance. When thesubstance attaches to skin (or hair), take off the contaminated clothes. Wash with a large
amount of water and soap. If the substance gets into your eyes, rinse your eyes thoroughly
for several minutes. If you wear contact lens, and you can take it off easily, take it off andcontinue to rinse your eyes. When it causes your skin irritation or eye irritation, consult doctor(medical diagnosis/therapy).
Waste water containing the substance must be passed the waste water treatment plants inorder to remove the substance. No specific measures are needed, because it is not expected
to be released into the air.

8. Regulatory Information / Classification and Labelling
Under GHS classification chemical substances are classified in hazards for physical properties,
human health and environment. The hazard information for industrial products are transmitted
via specific labels and Safety Data Sheet. GHS offers the standardization for hazard
communication. The subjects who could be assumed to be exposed to the substance, workers,consumers, transport workers, and emergency responders, can better understand the hazardsof the chemicals in use through the transmission.

Labeling according to UN GHS
UN GHS is the basis for country specific GHS labeling.
ANHITOL 55AB may be assigned to following GHS classification.

Classification and Labeling Information
Eye Damage 1
Aquatic Acute 2
Aquatic Chronic 3

Hazard Statements:
H319: Causes serious eye irritation
H401: Toxic to aquatic life
H412: Harmful to aquatic life with ling lasting effects

Signal WordDanger
The laws of manufacturing, sale, transport, use and disposal are different among countries orareas. Details are referred to Safety Data Sheet provided by the supplier.

9. Conclusion
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AMPHITOL 55AB could cause a toxicity to aquatic organisms. It also could cause harmfulness
to aquatic organisms with long lasting effects. However, AMPHITOL 55AB is unlikely to persist
in the environment because of showing the readily biodegradation. In the PBT/vPvB
assessments for AMPHITOL 55AB, the substance is not applicable to PBT/vPvB. When
handling the substance, workers should follow the standard safety measures and refer to theSafety Data Sheet. Consumers will usually not come into contact with the substance bulk andthe substance is used diluted products, therefore, it is considered that AMPHITOL 55AB gives
rise no hazardous effects to human health.

10. Contact information within company
For further information on this substance or product safety summaries in general, pleasecontact:
Name

Kao Corporation, Global Chemical Business

Telephone number+81-3-5630-7700

Fax number+81-3-5630-7889

E-mail address

chemical@kao.co.jp

Additional information can be found at a chemical risk assessment support portal provided by
the Japan Chemical Industry Associations, found at https://www.jcia-bigdr.jp/jcia-bigdr/en/top.

11. Glossary
Acute Toxicity

Adverse effects that result from a single exposure

Sensitization

Inducibility of allergy

Genotoxicity

Effects to induce gene mutations

Carcinogenicity

Action influence to cause a cancer
Adverse effects for teratogenicity, embryotoxicity, andreproductivity

Toxicity for Reproduction
Biodegradation
PBT(Persistent, Bioaccumulativeand Toxic)
vPvB(Very Persistent and Very
Bioaccumulative)
GHS

Biological degradation of a substance in environments
Substances that are environmentally persistent,bioaccumulative, and toxic
Substances with high persistence in the environmentand high accumulation in ecology
Globally Harmonized System of Classification andLabelling of Chemicals

12. Date of issue
December 10, 2021
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