Safety Data Sheetaccording to Regulation (EC) No. 1907/2006 (REACH)(This safety data sheet is for information only as it does notcomply with the official language requirements of Article 31 (5)of REACH nor does it provide the national information in sections
8 and 15 as specified in Annex II of REACH.)

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

1.1

1.2

Product identifier
Trade name

CellProtect 5

Unique formula identifier (UFI)

9190-A07X-A004-9M5R

Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses

1.3

Storage solution for AquaSpec™ Flow Cell

Details of the supplier of the safety data sheet
CLADE GmbH
Schelztorstraße 54-56
73728 Esslingen
Germany

Telephone: +49 711-400 52 400
e-mail: info@clade.io
Website: clade.io

e-mail (competent person)

nathalie.kittel@clade.io

National contact

Telephone: +49 711-400 52 400
e-Mail: info@clade.io

1.4

Emergency telephone number
As above or nearest toxicological information centre.

SECTION 2: Hazards identification

2.1

Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 (CLP)Classification
SectionHazard class

Category

Hazard class andcategory

Hazard statement

3.4S

skin sensitisation

1

Skin Sens. 1

H317

For full text of abbreviations: see SECTION 16

2.2

Label elements

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Labelling according to Regulation (EC) No 1272/2008 (CLP)
Signal word

warning

Pictograms
GHS07

Hazard statements
H317

May cause an allergic skin reaction.

Precautionary statements
P261

Avoid breathing mist/vapours/spray.

P280
P333+P313

Wear protective gloves/protective clothing/eye protection/face protection.
If skin irritation or rash occurs: Get medical advice/attention.

P362+P364
P501

Take off contaminated clothing and wash it before reuse.
Dispose of contents/container to an authorized waste treatment facility.

Hazardous ingredients for labelling

2.3

2-methyl-2H-isothiazol-3-one

Other hazards
Results of PBT and vPvB assessment
Does not contain a PBT-/vPvB-substance at a concentration of ≥ 0,1%.
Endocrine disrupting properties
Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%.

SECTION 3: Composition/information on ingredients

3.1

Substances
Not relevant (mixture).

3.2

Mixtures
Description of the mixture
Hazardous ingredients
Name of substance

Identifier

Wt%

Classification acc. to
GHS

2-methyl-2H-isothiazol-3-one

CAS No2682-20-4< 0.01

Acute Tox. 3 / H301
Acute Tox. 3 / H311
Acute Tox. 2 / H330
Skin Corr. 1B / H314
Eye Dam. 1 / H318
Skin Sens. 1A / H317
Aquatic Acute 1 / H400
Aquatic Chronic 1 / H410

EC No
220-239-6
Index No613-326-00-9

EU member state: en

Pictograms

Notes

GHS-HC

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Hazardous ingredients
Name of substance

Identifier

Wt%

Classification acc. to
GHS

Pictograms

Notes

EUH071
Notes
GHSHC:

Harmonised classification (the classification of the substance corresponds to the entry in the list according to1272/2008/EC, Annex VI)

Name of substanceSpecific Conc. Limits

M-Factors

ATE

Exposure route2-methyl-2H-isothiazol3-one

Skin Sens. 1A; H317: C ≥ 0.0015 %M-factor(acute) = 10
M-factor(chronic) = 1

232 mg/kg
242 mg/kg>0.5 mg/l/4h
0.11 mg/l/4h

oraldermalinhalation: vapour
inhalation: dust/
mist

Remarks
For full text of H-phrases: see SECTION 16

SECTION 4: First aid measures

4.1

Description of first aid measures
General notes
Self-protection of the first aider.
Remove affected person from the danger area and lay down.
Do not leave affected person unattended.
Take off immediately all contaminated clothing.
In all cases of doubt, or when symptoms persist, seek medical advice.
Following inhalation
Provide fresh air.
If breathing is irregular or stopped, immediately seek medical assistance and start first aid actions.
Following skin contact
Take off contaminated clothing.
After contact with skin, take off immediately all contaminated clothing, and wash immediately withplenty of water.
If skin irritation or rash occurs: Get medical advice/attention.
Following eye contact
Irrigate copiously with clean, fresh water, holding the eyelids apart.
Remove contact lenses, if present and easy to do. Continue rinsing.
Following ingestion
Rinse mouth. Do not induce vomiting.
Get medical advice/attention if you feel unwell.

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Notes for the doctor
None.

4.2

Most important symptoms and effects, both acute and delayed
Vomiting.
Diarrhoea.
Nausea.
May cause an allergic skin reaction.

4.3

Indication of any immediate medical attention and special treatment needed
None.

SECTION 5: Firefighting measures

5.1

Extinguishing media
Suitable extinguishing media
water spray, alcohol resistant foam, fire extinguishing powder, carbon dioxide (CO2)
Unsuitable extinguishing media
water jet

5.2

Special hazards arising from the substance or mixture
Hazardous decomposition products: Section 10.
Hazardous combustion products
nitrogen oxides (NOx)

5.3

Advice for firefighters
Non-combustible.
Keep containers cool with water spray.
In case of fire and/or explosion do not breathe fumes.
Co-ordinate firefighting measures to the fire surroundings.
Collect contaminated firefighting water separately.
Fight fire with normal precautions from a reasonable distance.
Special protective equipment for firefighters
Wear self-contained breathing apparatus

SECTION 6: Accidental release measures

6.1

Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
Remove persons to safety.
Ventilate affected area.
Wearing of suitable protective equipment (including personal protective equipment referred to under
Section 8 of the safety data sheet) to prevent any contamination of skin, eyes and personal clothing.

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For emergency responders
Wear breathing apparatus if exposed to vapours/dust/spray/gases.

6.2

Environmental precautions
Keep away from drains, surface and ground water.
Retain contaminated washing water and dispose of it.

6.3

Methods and material for containment and cleaning up
Advice on how to clean up a spill
Collect spillage.
Absorbent material (e.g. sand, diatomaceous earth, acid binder, universal binder, sawdust, etc.).
Appropriate containment techniques
Use of adsorbent materials.
Other information relating to spills and releases
Place in appropriate containers for disposal.
Ventilate affected area.

6.4

Reference to other sections
Hazardous combustion products: see section 5.
Personal protective equipment: see section 8.
Incompatible materials: see section 10.
Disposal considerations: see section 13.

SECTION 7: Handling and storage

7.1

Precautions for safe handling
Avoid contact with skin and eyes.
Do not breathe vapour/spray.
Measures to prevent fire as well as aerosol and dust generation
Use local and general ventilation.
Specific notes/details
None.
Measures to protect the environment
Avoid release to the environment.
Advice on general occupational hygiene
Do not eat, drink and smoke in work areas.
Wash hands after use.
Preventive skin protection (barrier creams/ointments) is recommended.
Remove contaminated clothing and protective equipment before entering eating areas.

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7.2

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Conditions for safe storage, including any incompatibilities
Flammability hazards
None.
Incompatible substances or mixtures
Incompatible materials: see section 10.
Store away from oxidizing agents.
Protect against external exposure, such as
frost
Consideration of other advice
Keep away from food, drink and animal feeding stuffs.
Ventilation requirements
Provision of sufficient ventilation.
Specific designs for storage rooms or vessels
Keep container tightly closed and in a well-ventilated place.
Packaging compatibilities
Keep only in original container.

7.3

Specific end use(s)No information available.

SECTION 8: Exposure controls/personal protection

8.1

Control parameters
Occupational exposure limit values (Workplace Exposure Limits)This information is not available
Human health values

Relevant DNELs of components of the mixture

Relevant DNELs of components
Name of substance

CAS NoEndpointThreshold levelProtection
goal, route of
exposure

Used in

Exposure time

2-methyl-2H-isothiazol-3-one

2682-20-4

DNEL

0.021 mg/m³

human, inhalatory

worker (industry)

chronic - local effects

Environmental values

EU member state: en

Relevant PNECs of components of the mixture

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Relevant PNECs of components

8.2

Name of substance

CAS NoEndpointThreshold level

Environmental compartment

2-methyl-2H-isothiazol-3-one

2682-20-4

PNEC

3.39 µg/l

freshwater

2-methyl-2H-isothiazol-3-one

2682-20-4

PNEC

3.39 µg/l

marine water

2-methyl-2H-isothiazol-3-one

2682-20-4

PNEC

0.23 mg/l

sewage treatment plant(STP)

2-methyl-2H-isothiazol-3-one

2682-20-4

PNEC

0.047 mg/kg

soil

Exposure controls
Appropriate engineering controls
Use local and general ventilation.
Individual protection measures (personal protective equipment)
Eye/face protection
Wear eye/face protection. (EN 166).
Hand protection
Protective gloves
Material

Material thickness

Breakthrough times of the glove
material

NBR: acrylonitrile-butadiene rubber≥ 0,11 mm>480 minutes (permeation: level 6)

Wear suitable gloves.
Chemical protection gloves are suitable, which are tested according to EN 374.
Check leak-tightness/impermeability prior to use.
For special purposes, it is recommended to check the resistance to chemicals of the protective gloves
mentioned above together with the supplier of these gloves.
Body protection
Protective clothing against liquid chemicals.
(EN 13832, EN 340, EN 14605).
Respiratory protection
In case of inadequate ventilation wear respiratory protection.
(EN 136, EN 140, EN 14387, EN 143, EN 149).
Environmental exposure controls
Use appropriate container to avoid environmental contamination.
Keep away from drains, surface and ground water.

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SECTION 9: Physical and chemical properties

9.1

Information on basic physical and chemical properties
Physical stateliquidColourcolourlessOdour

characteristic

Melting point/freezing point

0 °C

Boiling point or initial boiling point and boilingrange

100 °C

Flammability

non-combustible

Lower and upper explosion limit

not determinedFlash point

not determined

Auto-ignition temperature

not determined

Decomposition temperature

not relevant

pH (value)

6 – 8 (20 °C)

Kinematic viscosity

not determined

Dynamic viscosity

not determined

Solubility(ies)
Water solubility

not miscible in any proportion

Partition coefficient n-octanol/water (log value) not determined
Vapour pressure

not determined

Density and/or relative density
Density

1 g/cm³ at 20 °C

Relative vapour density

this information is not available

Particle characteristics

not relevant(liquid)9.2

Other information
Information with regard to physical hazard
classeshazard classes acc. to GHS (physical hazards):
not relevant

Other safety characteristics

there is no additional information

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SECTION 10: Stability and reactivity

10.1

Reactivity
This material is not reactive under normal ambient conditions.

10.2

Chemical stability
The material is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.
See below "Conditions to avoid".

10.3

Possibility of hazardous reactions
No known hazardous reactions.

10.4

Conditions to avoid
There are no specific conditions known which have to be avoided.

10.5

Incompatible materials
There is no additional information.

10.6

Hazardous decomposition products
Reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill
and heating are not known.
Hazardous combustion products: see section 5.

SECTION 11: Toxicological information

11.1

Information on hazard classes as defined in Regulation (EC) No 1272/2008
Classification procedure
If not otherwise specified the classification is based on:
Ingredients of the mixture (additivity formula).

Classification according to GHS (1272/2008/EC, CLP)
Acute toxicity
Test data are not available for the complete mixture.
Acute toxicity of components

Acute toxicity of components of the mixture

Acute toxicity estimate (ATE) of components
Name of substance

CAS NoExposure routeATE

2-methyl-2H-isothiazol-3-one

2682-20-4

oral

232 mg/kg

2-methyl-2H-isothiazol-3-one

2682-20-4

dermal242 mg/kg

2-methyl-2H-isothiazol-3-one

2682-20-4

inhalation: vapour>0.5 mg/l/4h

2-methyl-2H-isothiazol-3-one

2682-20-4

inhalation: dust/mist

0.11 mg/l/4h

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Acute toxicity of components
Name of substance

CAS NoExposureroute

Endpoint

Value

Species

MethodSource2-methyl-2H-isothiazol-3one

2682-20-4

oral

LD50

232 – 249
mg/kg

rat, maleEPA OPPTS
870.1100ECHA

2-methyl-2H-isothiazol-3one

2682-20-4

oral

LD50

120 mg/rat, female

EPA OPPTS
870.1100ECHAkg

2-methyl-2H-isothiazol-3one

2682-20-4

242 mg/rat

OECDGuideline
402

ECHA

2-methyl-2H-isothiazol-3one

2682-20-4

rat

OECD
Guideline
403

ECHA

dermalLD50kg

inhalation:
dust/

LC50

0.11 mg/
l/4h

mist

Skin corrosion/irritation
Shall not be classified as corrosive/irritant to skin.
Serious eye damage/eye irritation
Shall not be classified as seriously damaging to the eye or eye irritant.
Respiratory or skin sensitisation
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.
Germ cell mutagenicity
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.
Carcinogenicity
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.
Reproductive toxicity
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.
Specific target organ toxicity - single exposure
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.

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Specific target organ toxicity - repeated exposure
Classification could not be established because:
Data are lacking, inconclusive, or conclusive but not sufficient for classification.
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.

11.2

Information on other hazards
Endocrine disrupting properties
Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%.

SECTION 12: Ecological information

12.1

Toxicity
Aquatic toxicity (acute)
Based on available data, the classification criteria are not met.
Aquatic toxicity (acute) of components
Name of substance

CAS NoEndpoint

Exposure
time

Value

Species

MethodSource2-methyl-2Hisothiazol-3one

2682-20-4

EC50

96 h

0.069 mg/l

algae (Skeletonema costatum)OECD
Guideline
201

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

EC50

48 h

1.6 mg/l

daphnia magna

EPA OPP
72-2

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

LC50

48 h

0.934 mg/l

daphnia magna

OECD
Guideline
202

ECHA

2-methyl-2Hisothiazol-3-

2682-20-4

LC50

96 h

4.77 mg/l

rainbow trout(Oncorhynchus

OECD
Guideline

ECHA

mykiss)203

one
2-methyl-2Hisothiazol-3one

2682-20-4

ErC50

96 h

>0.072 mg/l

algae (Skeletonema costatum)OECD
Guideline
201

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

EbC50

96 h

0.063 mg/l

algae
(pseudokirchneriella subcapitata)OECD
Guideline
201

ECHA

Aquatic toxicity (chronic)
Based on available data, the classification criteria are not met.

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Aquatic toxicity (chronic) of components

12.2

Name of substance

CAS NoEndpoint

Exposure
time

Value

Species

MethodSource2-methyl-2Hisothiazol-3one

2682-20-4

EC50

21 d

1.4 mg/l

daphnia magna

OECD
Guideline
211

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

EC50

3h

41 mg/lactivatedsludge of a predominantly domestic sewage

OECD
Guideline
209

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

EC50

16 h

2.3 mg/l

activatedsludge(Pseudomonas
putida)DIN EN ISO
10712

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

NOEC

21 d

0.044 mg/l

daphnia magna

OECD
Guideline
211

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

NOEC

33 d

2.1 mg/lfathead minnow(Pimephales
promelas)OECD
Guideline
210

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

LOEC

21 d

0.089 mg/l

daphnia magna

OECD
Guideline
211

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

LOEC

33 d

4.2 mg/lfathead minnow(Pimephales
promelas)OECD
Guideline
210

ECHA

2-methyl-2Hisothiazol-3one

2682-20-4

growth (EbCx) 10%

16 h

1 mg/lactivatedsludge(Pseudomonas
putida)DIN EN ISO
10712

ECHA

Persistence and degradability
Biodegradation
Test data are not available for the complete mixture.
Degradability of components
Name ofsubstance

CAS NoProcess

Degradation
rate

Time

MethodSource2-methyl-2Hisothiazol-3one

2682-20-4

carbon dioxide generation

47.6 %29 d

OECD
Guideline 301
B

ECHA

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CAS NoProcess

Degradation

substance
2-methyl-2Hisothiazol-3one

Time

MethodSource28 d

OECDGuideline 301
D

ECHA

rate
2682-20-4

oxygen depletion

0%

Persistence
No data available.

12.3

Bioaccumulative potential
Bioaccumulative potential of components

12.4

Name of substance

CAS NoBCF

Log KOW

2-methyl-2H-isothiazol-3one

2682-20-4

5.75-0.486

Mobility in soil
No data available.

12.5

Results of PBT and vPvB assessment
Does not contain a PBT-/vPvB-substance at a concentration of ≥ 0,1%.

12.6

Endocrine disrupting properties
Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%.

12.7

Other adverse effects
Data are not available.

Remarks
Wassergefährdungsklasse, WGK (water hazard class): Nwg.

SECTION 13: Disposal considerations

13.1

Waste treatment methods
This material and its container must be disposed of as hazardous waste.
Sewage disposal-relevant information
Do not empty into drains.
Waste treatment of containers/packagings
Completely emptied packages can be recycled.
Handle contaminated packages in the same way as the substance itself.

Remarks
Please consider the relevant national or regional provisions.

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SECTION 14: Transport information

14.1

UN number or ID number

not assigned

14.2

UN proper shipping name

-

14.3

Transport hazard class(es)

-

14.4

Packing group

-

14.5

Environmental hazards

-

14.6

Special precautions for user

-

14.7

Maritime transport in bulk according to IMO instruments

SECTION 15: Regulatory information

15.1

Safety, health and environmental regulations/legislation specific for the substance or
mixtureRelevant provisions of the European Union (EU)
Restrictions according to REACH, Annex XVIINameName acc. to inventory

CAS NoRestriction

CellProtect 5

this product meets the criteria for classification in accordance with Regulation
No 1272/2008/EC-

R3

2-methyl-2H-isothiazol-3-one

substances in tattoo inks and permanent make-up-

R75

LegendR3

1. Shall not be used in:- ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,- tricks and jokes,- games for one or more participants, or any article intended to be used as such, even with ornamental aspects,
2. Articles not complying with paragraph 1 shall not be placed on the market.
3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they:— can be used as fuel in decorative oil lamps for supply to the general public, and— present an aspiration hazard and are labelled with H304.
4. Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to
the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN).
5. Without prejudice to the implementation of other Union provisions relating to the classification, labelling andpackaging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met:(a) lamp oils, labelled with H304, intended for supply to the general public are visibly, legibly and indelibly
marked as follows: “Keep lamps filled with this liquid out of the reach of children”; and, by 1 December 2010, “Justa sip of lamp oil – or even sucking the wick of lamps – may lead to life-threatening lung damage”;(b) grill lighter fluids, labelled with H304, intended for supply to the general public are legibly and indelibly

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Legendmarked by 1 December 2010 as follows: ‘Just a sip of grill lighter fluid may lead to life threatening lung damage’;(c) lamps oils and grill lighters, labelled with H304, intended for supply to the general public are packaged inblack opaque containers not exceeding 1 litre by 1 December 2010.’;

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LegendR75

1. Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any
such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances inquestion is or are present in the following circumstances:(a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;(b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than
0,001 % by weight;(c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser
category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 %by weight;(d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive
category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category
2, the substance is present in the mixture in a concentration equal to or greater than:(i) 0,1 % by weight, if the substance is used solely as a pH regulator;(ii) 0,01 % by weight, in all other cases;(e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009 (*1), the substance is present in
the mixture in a concentration equal to or greater than 0,00005 % by weight;(f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g(Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in
the mixture in a concentration equal to or greater than 0,00005 % by weight:(i) “Rinse-off products”;(ii) “Not to be used in products applied on mucous membranes”;(iii) “Not to be used in eye products”;(g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready foruse preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance ispresent in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column;(h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in aconcentration equal to or greater than the concentration limit specified for that substance in that Appendix.
2. For the purposes of this entry use of a mixture “for tattooing purposes” means injection or introduction of the
mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures
commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), withthe aim of making a mark or design on his or her body.
3. If a substance not listed in Appendix 13 falls within more than one of points (a) to (g) of paragraph 1, the strictest concentration limit laid down in the points in question shall apply to that substance. If a substance listed inAppendix 13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down inpoint (h) of paragraph 1 shall apply to that substance.
4. By way of derogation, paragraph 1 shall not apply to the following substances until 4 January 2023:(a) Pigment Blue 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8);(b) Pigment Green 7 (CI 74260, EC No 215-524-7, CAS No 1328-53-6).
5. If Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended after 4 January 2021 to classify or re-classify
a substance such that the substance then becomes caught by point (a), (b), (c) or (d) of paragraph 1 of this entry,
or such that it then falls within a different one of those points from the one within which it fell previously, and thedate of application of that new or revised classification is after the date referred to in paragraph 1 or, as the casemay be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect on the date of application of that new or revised classification.
6. If Annex II or Annex IV to Regulation (EC) No 1223/2009 is amended after 4 January 2021 to list or change thelisting of a substance such that the substance then becomes caught by point (e), (f) or (g) of paragraph 1 of thisentry, or such that it then falls within a different one of those points from the one within which it fell previously,
and the amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 ofthis entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking
effect from the date falling 18 months after entry into force of the act by which that amendment was made.
7. Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after 4 January2022, the mixture is marked with the following information:

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Legend(a) the statement “Mixture for use in tattoos or permanent make-up”;(b) a reference number to uniquely identify the batch;(c) the list of ingredients in accordance with the nomenclature established in the glossary of common ingredient
names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name,the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients at the time of formulation. “Ingredient” means any substance added during the process of formulation and present in the mixture for use fortattooing purposes. Impurities shall not be regarded as ingredients. If the name of a substance, used as ingredient within the meaning of this entry, is already required to be stated on the label in accordance with Regulation(EC) No 1272/2008, that ingredient does not need to be marked in accordance with this Regulation;(d) the additional statement “pH regulator” for substances falling under point (d)(i) of paragraph 1;(e) the statement "Contains nickel. Can cause allergic reactions." if the mixture contains nickel below the concentration limit specified in Appendix 13;(f) the statement "Contains chromium (VI). Can cause allergic reactions." if the mixture contains chromium (VI)below the concentration limit specified in Appendix 13;(g) safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC)No 1272/2008.
The information shall be clearly visible, easily legible and marked in a way that is indelible.
The information shall be written in the official language(s) of the Member State(s) where the mixture is placed on
the market, unless the Member State(s) concerned provide(s) otherwise.
Where necessary because of the size of the package, the information listed in the first subparagraph, except forpoint (a), shall be included instead in the instructions for use.
Before using a mixture for tattooing purposes, the person using the mixture shall provide the person undergoing the procedure with the information marked on the package or included in the instructions for use pursuant
to this paragraph.
8. Mixtures that do not contain the statement “Mixture for use in tattoos or permanent make-up” shall not be
used for tattooing purposes.
9. This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or
generate a vapour pressure of more than 300 kPa at temperature of 50 °C, with the exception of formaldehyde(CAS No 50-00-0, EC No 200-001-8).
10. This entry does not apply to the placing on the market of a mixture for use for tattooing purposes, or to theuse of a mixture for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, within the meaning of Regulation (EU) 2017/745, or when used exclusively as a medical
device or an accessory to a medical device, within the same meaning. Where the placing on the market or use
may not be exclusively as a medical device or an accessory to a medical device, the requirements of Regulation(EU) 2017/745 and of this Regulation shall apply cumulatively.

List of substances subject to authorisation (REACH, Annex XIV) / SVHC - candidate list
None of the ingredients are listed.

Seveso Directive
Not assigned.

Directive on the restriction of the use of certain hazardous substances in electrical andelectronic equipment (RoHS)
None of the ingredients are listed.

Regulation on the marketing and use of explosives precursors
None of the ingredients are listed.

Regulation on drug precursors
None of the ingredients are listed.
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Regulation on substances that deplete the ozone layer (ODS)
None of the ingredients are listed.

Regulation concerning the export and import of hazardous chemicals (PIC)
None of the ingredients are listed.

Regulation on persistent organic pollutants (POP)None of the ingredients are listed.

15.2

Chemical Safety Assessment
No Chemical Safety Assessment has been carried out for this mixture by the supplier.

SECTION 16: Other information

Abbreviations and acronyms
Abbr.

Descriptions of used abbreviations

Acute Tox.

Acute toxicity

ADN

Accord européen relatif au transport international des marchandises dangereuses par voies de navigation intérieures (European Agreement concerning the International Carriage of Dangerous Goods
by Inland Waterways)

ADR

Accord relatif au transport international des marchandises dangereuses par route (Agreement concerning the International Carriage of Dangerous Goods by Road)

Aquatic Acute

Hazardous to the aquatic environment - acute hazard

Aquatic Chronic

Hazardous to the aquatic environment - chronic hazard

ATE

Acute Toxicity Estimate

BCF

Bioconcentration factor

CAS

Chemical Abstracts Service (service that maintains the most comprehensive list of chemical substances)

CLP

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

DGR

Dangerous Goods Regulations (see IATA/DGR)

DNELDerived No-Effect Level

EbC50≡ EC50: in this method, that concentration of test substance which results in a 50 % reduction ineither growth (EbC50) or growth rate (ErC50) relative to the control

EC50

Effective Concentration 50 %. The EC50 corresponds to the concentration of a tested substance causing 50 % changes in response (e.g. on growth) during a specified time interval

EC No

The EC Inventory (EINECS, ELINCS and the NLP-list) is the source for the seven-digit EC number, an
identifier of substances commercially available within the EU (European Union)

ED

Endocrine disruptor

EINECS

European Inventory of Existing Commercial Chemical Substances

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Abbr.

Descriptions of used abbreviations

ELINCS

European List of Notified Chemical Substances

ErC50≡ EC50: in this method, that concentration of test substance which results in a 50 % reduction ineither growth (EbC50) or growth rate (ErC50) relative to the control

Eye Dam.

Seriously damaging to the eye

Eye Irrit.

Irritant to the eye

GHS"Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United
Nations

IATA

International Air Transport Association

IATA/DGR

Dangerous Goods Regulations (DGR) for the air transport (IATA)

IMDGInternational Maritime Dangerous Goods Codeindex NoThe Index number is the identification code given to the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008

LC50

Lethal Concentration 50%: the LC50 corresponds to the concentration of a tested substance causing
50 % lethality during a specified time interval

LD50

Lethal Dose 50 %: the LD50 corresponds to the dose of a tested substance causing 50 % lethality during a specified time interval

LOEC

Lowest Observed Effect Concentration

log KOW

n-Octanol/water

M-factor

Means a multiplying factor. It is applied to the concentration of a substance classified as hazardous
to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present

NLP

No-Longer Polymer

NOEC

No Observed Effect Concentration

PBT

Persistent, Bioaccumulative and Toxic

PNEC

Predicted No-Effect Concentration

REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals

RID

Règlement concernant le transport International ferroviaire des marchandises Dangereuses (Regulations concerning the International carriage of Dangerous goods by Rail)Skin Corr.

Corrosive to skin

Skin Irrit.

Irritant to skin

Skin Sens.

Skin sensitisation

SVHC

Substance of Very High Concern

vPvB

Very Persistent and very Bioaccumulative

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Key literature references and sources for data
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Regulation (EC) No. 1907/2006 (REACH), amended by 2020/878/EU.
Transport of dangerous goods by road, rail and inland waterway (ADR/RID/ADN).
International Maritime Dangerous Goods Code (IMDG).
Dangerous Goods Regulations (DGR) for the air transport (IATA).

Classification procedure
Physical and chemical properties.
Health hazards.
Environmental hazards.
The method for classification of the mixture is based on ingredients of the mixture (additivity formula).

List of relevant phrases (code and full text as stated in section 2 and 3)
Code

Text

H301

Toxic if swallowed.

H311

Toxic in contact with skin.

H314

Causes severe skin burns and eye damage.

H317

May cause an allergic skin reaction.

H318

Causes serious eye damage.

H330

Fatal if inhaled.

H400

Very toxic to aquatic life.

H410

Very toxic to aquatic life with long lasting effects.

Responsible for the safety data sheet

C.S.B. GmbH
Dujardinstr. 547829 Krefeld
Germany

Telephone: +49 (0) 2151 - 652086 - 0
Telefax: +49 (0) 2151 - 652086 - 9
e-Mail: info@csb-compliance.com
Website: www.csb-compliance.com

Disclaimer
This information is based upon the present state of our knowledge.
This SDS has been compiled and is solely intended for this product.

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