Safety data sheet

according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642 date of compilation: 14.09.2021

Version: 1.0 en

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

undertaking
1.1 Product identifier
Identification of the substance Fatty acid methyl ester mixture ROTICHROM®
ME 13
Article number 8642
Registration number (REACH) not relevant (mixture)
Alternative name(s) FAME
1.2 Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses: Laboratory chemical
Laboratory and analytical use
Uses advised against: Do not use for products which come into contact
with foodstuffs. Do not use for private purposes
(household).
1.3 Details of the supplier of the safety data sheet
Carl Roth GmbH + Co KG
Schoemperlenstr. 3-5
D-76185 Karlsruhe
Germany

Telephone:+49 (0) 721 - 56 06 0

Telefax: +49 (0) 721 - 56 06 149
e-mail: sicherheit@carlroth.de
Website: www.carlroth.de
Competent person responsible for the safety data :Department Health, Safety and Environment
sheet:
e-mail (competent person): sicherheit@carlroth.de
1.4 Emergency telephone number

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 (CLP)
Section Hazard class Cat- Hazard class and Hazard
egory category statement

3.1O Acute toxicity (oral) 4 Acute Tox. 4 H302

3.1I Acute toxicity (inhal.) 3 Acute Tox. 3 H331

3.2 Skin corrosion/irritation 2 Skin Irrit. 2 H315

3.3 Serious eye damage/eye irritation 2 Eye Irrit. 2 H319

3.6 Carcinogenicity 2 Carc. 2 H351

3.7 Reproductive toxicity 2 Repr. 2 H361d

3.9 Specific target organ toxicity - repeated exposure 1 STOT RE 1 H372

For full text of abbreviations: see SECTION 16

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

The most important adverse physicochemical, human health and environmental effects
Delayed or immediate effects can be expected after short or long-term exposure.
2.2 Label elements
Labelling according to Regulation (EC) No 1272/2008 (CLP)

Signal word Danger

Pictograms

GHS06, GHS08

Hazard statements
H302 Harmful if swallowed
H315 Causes skin irritation
H319 Causes serious eye irritation
H331 Toxic if inhaled
H351 Suspected of causing cancer
H361d Suspected of damaging the unborn child
H372 Causes damage to organs through prolonged or repeated exposure

Precautionary statements
Precautionary statements - prevention
P202 Do not handle until all safety precautions have been read and understood
P260 Do not breathe mist/vapours/spray
P270 Do not eat, drink or smoke when using this product
P280 Wear protective gloves/eye protection
Precautionary statements - response
P302+P352 IF ON SKIN: Wash with plenty of water
P308+P313 IF exposed or concerned: Get medical advice/attention

For professional users only

Hazardous ingredients for labelling: Trichloromethane

Labelling of packages where the contents do not exceed 125 ml

Signal word: Danger

Symbol(s)

H331 Toxic if inhaled.

H351 Suspected of causing cancer.
H361d Suspected of damaging the unborn child.
H372 Causes damage to organs through prolonged or repeated exposure.
P202 Do not handle until all safety precautions have been read and understood.
P260 Do not breathe mist/vapours/spray.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/eye protection.
P308+P313 IF exposed or concerned: Get medical advice/attention.
contains: Trichloromethane

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

2.3 Other hazards
Results of PBT and vPvB assessment
This mixture does not contain any substances that are assessed to be a PBT or a vPvB.

SECTION 3: Composition/information on ingredients

3.1 Substances
not relevant (mixture)
3.2 Mixtures
Description of the mixture
Name of sub- Identifier Wt% Classification acc. to Pictograms Notes
stance GHS

Trichloromethane CAS No 80 – < 100 Acute Tox. 4 / H302 GHS-HC

67-66-3 Acute Tox. 3 / H331 IARC: 2B
Skin Irrit. 2 / H315 IOELV
EC No Eye Irrit. 2 / H319
200-663-8 Carc. 2 / H351
Repr. 2 / H361d
Index No STOT RE 1 / H372
602-006-00-4

REACH Reg. No
01-2119486657-
20-xxxx

Notes
GHS-HC: Harmonised classification (the classification of the substance corresponds to the entry in the list according to 1272/
2008/EC, Annex VI)
IARC: IARC group 2B: possibly carcinogenic to humans (International Agency for Research on Cancer)
2B:
IOELV: Substance with a community indicative occupational exposure limit value

Name of sub- Identifier Specific Conc. Limits M-Factors ATE Exposure

stance route

Trichlorometh- CAS No - - 908 mg/kg oral

ane 67-66-3 3 mg/l/4h inhalation: va-
pour
EC No
200-663-8

Index No
602-006-00-4

For full text of abbreviations: see SECTION 16

SECTION 4: First aid measures

4.1 Description of first aid measures

General notes
Self-protection of the first aider.
Following inhalation
Call a physician immediately. If breathing is irregular or stopped, administer artificial respiration.

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Following skin contact
Rinse skin with water/shower. In case of skin irritation, consult a physician.
Following eye contact
Irrigate copiously with clean, fresh water for at least 10 minutes, holding the eyelids apart. In case of
eye irritation consult an ophthalmologist.
Following ingestion
Rinse mouth with water (only if the person is conscious). In case of accident or unwellness, seek med-
ical advice immediately (show directions for use or safety data sheet if possible).
4.2 Most important symptoms and effects, both acute and delayed
Irritation, Nausea, Vomiting, Dizziness, Headache, Cough, Vertigo, Spasms, Dyspnoea, Unconscious-
ness
4.3 Indication of any immediate medical attention and special treatment needed
none

SECTION 5: Firefighting measures

5.1 Extinguishing media

Suitable extinguishing media

co-ordinate firefighting measures to the fire surroundings
water spray, dry extinguishing powder, BC-powder, carbon dioxide (CO₂)
Unsuitable extinguishing media
water jet
5.2 Special hazards arising from the substance or mixture
None.
Hazardous combustion products
Carbon monoxide (CO), Carbon dioxide (CO₂), Hydrogen chloride (HCl), Hydrogen halides (HX)
5.3 Advice for firefighters
In case of fire and/or explosion do not breathe fumes. Fight fire with normal precautions from a reas-
onable distance. Wear self-contained breathing apparatus.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

For non-emergency personnel

Do not breathe vapour/spray. Use personal protective equipment as required. Avoid contact with
skin, eyes and clothes. Provide adequate ventilation.
6.2 Environmental precautions
Keep away from drains, surface and ground water.

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

6.3 Methods and material for containment and cleaning up
Advice on how to contain a spill
Covering of drains.
Advice on how to clean up a spill
Absorb with liquid-binding material (sand, diatomaceous earth, acid- or universal binding agents).
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. Incom-
patible materials: see section 10. Disposal considerations: see section 13.

SECTION 7: Handling and storage

7.1 Precautions for safe handling
Use extractor hood (laboratory). Avoid exposure. When not in use, keep containers tightly closed.
Advice on general occupational hygiene
Wash hands before breaks and after work.
7.2 Conditions for safe storage, including any incompatibilities
Keep container tightly closed in a cool place.
Incompatible substances or mixtures
Observe hints for combined storage.
Consideration of other advice:
Store locked up.
Ventilation requirements
Keep any substance that emits harmful vapours or gases in a place that allows these to be perman-
ently extracted.
Specific designs for storage rooms or vessels
Recommended storage temperature: 2 – 8 °C
7.3 Specific end use(s)
No information available.

SECTION 8: Exposure controls/personal protection

8.1 Control parameters
National limit values
Occupational exposure limit values (Workplace Exposure Limits)
Cou Name of agent CAS No Identi- TW TWA STE STEL Ceil Ceil- Nota- Source
ntr fier A [mg/ L [mg/ ing- ing-C tion
y [pp m³] [pp m³] C [mg/
m] m] [pp m³]
m]

EU chloroform 67-66-3 IOELV 2 10 2000/39/

EC

MT chloroform 67-66-3 OELV 2 10 CAP. 424

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Notation
Ceiling-C Ceiling value is a limit value above which exposure should not occur
STEL Short-term exposure limit: a limit value above which exposure should not occur and which is related to a 15-
minute period (unless otherwise specified)
TWA Time-weighted average (long-term exposure limit): measured or calculated in relation to a reference period of 8
hours time-weighted average (unless otherwise specified)

Relevant DNELs of components of the mixture

Name of sub- CAS No End- Threshol Protection Used in Exposure time

stance point d level goal, route of
exposure

Trichloromethane 67-66-3 DNEL 2,5 mg/m³ human, inhalat- worker (industry) chronic - systemic
ory effects

Trichloromethane 67-66-3 DNEL 333 mg/m³ human, inhalat- worker (industry) acute - systemic
ory effects

Trichloromethane 67-66-3 DNEL 2,5 mg/m³ human, inhalat- worker (industry) chronic - local ef-
ory fects

Trichloromethane 67-66-3 DNEL 0,94 mg/kg human, dermal worker (industry) chronic - systemic
bw/day effects

Relevant PNECs of components of the mixture

Name of sub- CAS No End- Threshol Organism Environmental Exposure time

stance point d level compartment

Trichloromethane 67-66-3 PNEC 0,146 mg/l aquatic organ- freshwater short-term (single
isms instance)

Trichloromethane 67-66-3 PNEC 0,015 mg/l aquatic organ- marine water short-term (single
isms instance)

Trichloromethane 67-66-3 PNEC 0,048 mg/l aquatic organ- sewage treatment short-term (single
isms plant (STP) instance)

Trichloromethane 67-66-3 PNEC 0,45 mg/kg aquatic organ- freshwater sedi- short-term (single
isms ment instance)

Trichloromethane 67-66-3 PNEC 0,09 mg/kg aquatic organ- marine sediment short-term (single
isms instance)

Trichloromethane 67-66-3 PNEC 0,56 mg/kg terrestrial organ- soil short-term (single
isms instance)

8.2 Exposure controls

Individual protection measures (personal protective equipment)
Eye/face protection

Use safety goggle with side protection.

Skin protection

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

• hand protection
Wear suitable gloves. Chemical protection gloves are suitable, which are tested according to EN 374.
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. The times are approximate values from
measurements at 22 ° C and permanent contact. Increased temperatures due to heated substances,
body heat etc. and a reduction of the effective layer thickness by stretching can lead to a consider-
able reduction of the breakthrough time. If in doubt, contact manufacturer. At an approx. 1.5 times
larger / smaller layer thickness, the respective breakthrough time is doubled / halved. The data apply
only to the pure substance. When transferred to substance mixtures, they may only be considered as
a guide.
• type of material
FKM (fluoro rubber)
• material thickness
≥0,4 mm
• breakthrough times of the glove material
>480 minutes (permeation: level 6)
• other protection measures
Take recovery periods for skin regeneration. Preventive skin protection (barrier creams/ointments) is
recommended.
Respiratory protection

Respiratory protection necessary at: Aerosol or mist formation. Type: AX (gas filters and combined fil-
ters against low-boiling point organic compounds, colour code: Brown).
Environmental exposure controls
Keep away from drains, surface and ground water.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties
Physical state liquid
Colour colourless
Odour characteristic
Melting point/freezing point -63 °C data apply to the main component
Boiling point or initial boiling point and boiling 61 °C at 1.013 hPa data apply to the main com-
range ponent
Flammability this material is combustible, but will not ignite
readily
Lower and upper explosion limit not determined
Flash point not determined
Auto-ignition temperature not determined
Decomposition temperature not relevant
pH (value) not determined

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Kinematic viscosity not determined
 
Solubility(ies)
Water solubility not determined
 
Partition coefficient
Partition coefficient n-octanol/water (log value): this information is not available
 
Vapour pressure 211 hPa at 20 °C
data apply to the main component
 
Density 1,48 g/cm³ at 20 °C data apply to the main com-
ponent
Relative vapour density information on this property is not available
 
Particle characteristics not relevant (liquid)
 
Other safety parameters
Oxidising properties none
9.2 Other information
Information with regard to physical hazard hazard classes acc. to GHS
classes: (physical hazards): not relevant
Other safety characteristics: There is no additional information.

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 tem-
perature and pressure.
10.3 Possibility of hazardous reactions

Violent reaction with: strong oxidiser, Acetone, Alkali metals, Alkaline earth metal, Metal powder,
Mineral acids, Nitro compound, Peroxides,
=> Explosive properties
10.4 Conditions to avoid
There are no specific conditions known which have to be avoided.
10.5 Incompatible materials
plastic and rubber, Light metals
10.6 Hazardous decomposition products
Hazardous combustion products: see section 5.

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

SECTION 11: Toxicological information

11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Test data are not available for the complete mixture.
Classification procedure
The method for classification of the mixture is based on ingredients of the mixture (additivity
formula).
Classification according to GHS (1272/2008/EC, CLP)
Acute toxicity
Harmful if swallowed. Toxic if inhaled.

Acute toxicity estimate (ATE) of components of the mixture

Name of substance CAS No Exposure route ATE

Trichloromethane 67-66-3 oral 908 mg/kg

Trichloromethane 67-66-3 inhalation: vapour 3 mg/l/4h

Acute toxicity of components of the mixture

Name of substance CAS No Exposure Endpoint Value Species

route

Trichloromethane 67-66-3 oral LD50 908 mg/kg rat

Skin corrosion/irritation
Causes skin irritation.
Serious eye damage/eye irritation
Causes serious eye irritation.
Respiratory or skin sensitisation
Shall not be classified as a respiratory or skin sensitiser.
Germ cell mutagenicity
Shall not be classified as germ cell mutagenic.
Carcinogenicity
Suspected of causing cancer.
Reproductive toxicity
Suspected of damaging the unborn child.
Specific target organ toxicity - single exposure
Shall not be classified as a specific target organ toxicant (single exposure).
Specific target organ toxicity - repeated exposure
Causes damage to organs through prolonged or repeated exposure.
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.

Symptoms related to the physical, chemical and toxicological characteristics

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

• If swallowed
vomiting, nausea
• If in eyes
Causes serious eye irritation
• If inhaled
vertigo, dizziness, cough, headache
• If on skin
causes skin irritation
• Other information
Other adverse effects: Spasms, Dyspnoea, Unconsciousness, Loss of righting reflex, and ataxia
11.2 Endocrine disrupting properties
None of the ingredients are listed.
11.3 Information on other hazards
There is no additional information.

SECTION 12: Ecological information

12.1 Toxicity
Shall not be classified as hazardous to the aquatic environment.
.

Aquatic toxicity (acute) of components of the mixture

Name of sub- CAS No Endpoint Value Species Exposure

stance time

Trichloromethane 67-66-3 EC50 152,5 mg/l aquatic invertebrates 48 h

Trichloromethane 67-66-3 ErC50 13,3 mg/l algae 72 h

Aquatic toxicity (chronic) of components of the mixture

Name of sub- CAS No Endpoint Value Species Exposure

stance time

Trichloromethane 67-66-3 EC50 0,48 mg/l microorganisms 24 h

Biodegradation
Data are not available.
12.2 Process of degradability

Degradability of components of the mixture

Name of CAS No Process Degrada- Time Method Source

substance tion rate

Trichlorometh- 67-66-3 biotic/abiotic 0% 14 d

ane

12.3 Bioaccumulative potential

Data are not available.

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Bioaccumulative potential of components of the mixture

Name of substance CAS No BCF Log KOW BOD5/COD

Trichloromethane 67-66-3 1,97 (25 °C)

12.4 Mobility in soil

Data are not available.
12.5 Results of PBT and vPvB assessment
Data are not available.
12.6 Endocrine disrupting properties
None of the ingredients are listed.
12.7 Other adverse effects
Data are not available.

SECTION 13: Disposal considerations

13.1 Waste treatment methods

This material and its container must be disposed of as hazardous waste. Dispose of contents/contain-
er in accordance with local/regional/national/international regulations.
Sewage disposal-relevant information
Do not empty into drains.
Waste treatment of containers/packagings
It is a dangerous waste; only packagings which are approved (e.g. acc. to ADR) may be used.
13.2 Relevant provisions relating to waste
The allocation of waste identity numbers/waste descriptions must be carried out according to the
EEC, specific to the industry and process. Waste catalogue ordinance (Germany).
13.3 Remarks
Waste shall be separated into the categories that can be handled separately by the local or national
waste management facilities. Please consider the relevant national or regional provisions.

SECTION 14: Transport information

14.1 UN number or ID number
ADR/RID/ADN UN 1888
IMDG-Code UN 1888
ICAO-TI UN 1888
14.2 UN proper shipping name
ADR/RID/ADN CHLOROFORM
IMDG-Code CHLOROFORM
ICAO-TI Chloroform

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

14.3 Transport hazard class(es)
ADR/RID/ADN 6.1
IMDG-Code 6.1
ICAO-TI 6.1
14.4 Packing group
ADR/RID/ADN III
IMDG-Code III
ICAO-TI III
14.5 Environmental hazards non-environmentally hazardous acc. to the dan-
gerous goods regulations
14.6 Special precautions for user
Provisions for dangerous goods (ADR) should be complied within the premises.
14.7 Maritime transport in bulk according to IMO instruments
The cargo is not intended to be carried in bulk.

14.8 Information for each of the UN Model Regulations

Transport of dangerous goods by road, rail and inland waterway (ADR/RID/ADN) - Additional
information
Proper shipping name CHLOROFORM
Particulars in the transport document UN1888, CHLOROFORM, 6.1, III, (E)
Classification code T1
Danger label(s) 6.1

Special provisions (SP) 802(ADN)

Excepted quantities (EQ) E1
Limited quantities (LQ) 5L
Transport category (TC) 2
Tunnel restriction code (TRC) E
Hazard identification No 60
International Maritime Dangerous Goods Code (IMDG) - Additional information
Proper shipping name CHLOROFORM
Particulars in the shipper's declaration UN1888, CHLOROFORM, 6.1, III
Marine pollutant -
Danger label(s) 6.1

Special provisions (SP) -

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Safety data sheet
according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Excepted quantities (EQ) E1
Limited quantities (LQ) 5L
EmS F-A, S-A
Stowage category A
Segregation group 10 - Liquid halogenated hydrocarbons
International Civil Aviation Organization (ICAO-IATA/DGR) - Additional information
Proper shipping name Chloroform
Particulars in the shipper's declaration UN1888, Chloroform, 6.1, III
Danger label(s) 6.1

Excepted quantities (EQ) E1

Limited quantities (LQ) 2L

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant provisions of the European Union (EU)
Restrictions according to REACH, Annex XVII

Dangerous substances with restrictions (REACH, Annex XVII)

Name of substance Name acc. to inventory CAS No Restriction No

Fatty acid methyl ester mixture this product meets the criteria for R3 3
classification in accordance with Reg-
ulation No 1272/2008/EC

Trichloromethane chloroform 67-66-3 R32-38 32

Trichloromethane substances in tattoo inks and perman- R75 75

ent make-up

Legend
R3 1. Shall not be used in:
- ornamental articles intended to produce light or colour effects by means of different phases, for example in orna-
mental 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 and pack-
aging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following require-
ments 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, “Just a 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 marked 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 in black
opaque containers not exceeding 1 litre by 1 December 2010.’;

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Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Legend
R32-38 1. Shall not be placed on the market, or used,
- as substances,
- as constituents of other substances, or in mixtures in concentrations equal to or greater than 0,1 % by weight,
where the substance or mixture is intended for supply to the general public and/or is intended for diffusive applica-
tions such as in surface cleaning and cleaning of fabrics.
2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of
substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such sub-
stances and mixtures containing them in concentrations equal to or greater than 0,1 % by weight is visibly, legibly and
indelibly marked as follows:
‘For use in industrial installations only’.
By way of derogation this provision shall not apply to:
(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;
(b) cosmetic products as defined by Directive 76/768/EEC.

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according to Regulation (EC) No. 1907/2006 (REACH)

Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

Legend
R75 1. Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such sub-
stances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question 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 cat-
egory 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 cat-
egory 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 for use
preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present 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 a concen-
tration 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 mix-
ture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures com-
monly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the 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 in Appendix
13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down in point (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 sub-
stance 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 the date of ap-
plication of that new or revised classification is after the date referred to in paragraph 1 or, as the case may be, para-
graph 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 the listing
of a substance such that the substance then becomes caught by point (e), (f) or (g) 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 the
amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this 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 January 2022, the
mixture is marked with the following information:
(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 for tattooing purposes. Im-
purities 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 ingredi-
ent 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 concentra-
tion 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 for point
(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 para-
graph.
8. Mixtures that do not contain the statement “Mixture for use in tattoos or permanent make-up” shall not be used for
tattooing purposes.

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Fatty acid methyl ester mixture ROTICHROM® ME 13

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Legend
9. This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or gener-
ate 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 the use 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 exclus-
ively 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. (Or Concentration of the substance in a mixture: <0.1 % Mass con-
centration)
Seveso Directive

2012/18/EU (Seveso III)

No Dangerous substance/hazard categories Qualifying quantity (tonnes) for the ap- Notes
plication of lower and upper-tier re-
quirements

H2 acute toxic (cat. 2 + cat. 3, inhal.) 50 200 41)

Notation
41) - Category 2, all exposure routes
- category 3, inhalation exposure route

Deco-Paint Directive

VOC content 92 %
, 1.362 g/l

Industrial Emissions Directive (IED)

VOC content 90 %

VOC content 1.332 g/l

Directive on the restriction of the use of certain hazardous substances in electrical and
electronic equipment (RoHS)
none of the ingredients are listed
Regulation concerning the establishment of a European Pollutant Release and Transfer
Register (PRTR)

Pollutant release and transfer registers (PRTR)

Name of substance CAS No Remarks Threshold for releases to air

(kg/year)

Trichloromethane 67-66-3 500

Water Framework Directive (WFD)

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Fatty acid methyl ester mixture ROTICHROM® ME 13

article number: 8642

List of pollutants (WFD)

Name of substance Name acc. to inventory CAS No Listed in Remarks

Trichloromethane trichloromethane (chloroform) 67-66-3 B)

Trichloromethane trichloromethane 67-66-3 C)

Trichloromethane Organohalogen compounds and A)

substances which may form such
compounds in the aquatic envir-
onment

Trichloromethane Substances and preparations, or A)

the breakdown products of such,
which have been proved to pos-
sess carcinogenic or mutagenic
properties or properties which
may affect steroidogenic, thyroid,
reproduction or other endocrine-
related functions in or via the
aquatic environment

Legend
A) Indicative list of the main pollutants
B) List of priority substances in the field of water policy
C) Environmental Quality Standards for Priority Substances and certain other pollutants

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
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)
chemicals subject to the international prior informed consent (PIC) procedure (the ‘PIC procedure’).
Name of substance Name acc. to inventory CAS No Category / Use limita-
subcategory tion

Trichloromethane chloroform 67-66-3 i(2) b

Legend
b Use limitation: ban (for the sub-category or sub-categories concerned) according to Union legislation
i(2) Sub-category: i(2) - industrial chemical for public use

Regulation on persistent organic pollutants (POP)

none of the ingredients are listed

Other information
Directive 94/33/EC on the protection of young people at work. Observe employment restrictions un-
der the Maternity Protection Directive (92/85/EEC) for expectant or nursing mothers.
National inventories

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Fatty acid methyl ester mixture ROTICHROM® ME 13

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Country Inventory Status

AU AICS not all ingredients are listed

CA DSL not all ingredients are listed

CA NDSL not all ingredients are listed

CN IECSC all ingredients are listed

EU ECSI all ingredients are listed

EU REACH Reg. not all ingredients are listed

JP CSCL-ENCS all ingredients are listed

KR KECI all ingredients are listed

MX INSQ not all ingredients are listed

NZ NZIoC all ingredients are listed

PH PICCS not all ingredients are listed

TR CICR not all ingredients are listed

TW TCSI all ingredients are listed

US TSCA not all ingredients are listed

Legend
AICS Australian Inventory of Chemical Substances
CICR Chemical Inventory and Control Regulation
CSCL-ENCS List of Existing and New Chemical Substances (CSCL-ENCS)
DSL Domestic Substances List (DSL)
ECSI EC Substance Inventory (EINECS, ELINCS, NLP)
IECSC Inventory of Existing Chemical Substances Produced or Imported in China
INSQ National Inventory of Chemical Substances
KECI Korea Existing Chemicals Inventory
NDSL Non-domestic Substances List (NDSL)
NZIoC New Zealand Inventory of Chemicals
PICCS Philippine Inventory of Chemicals and Chemical Substances (PICCS)
REACH Reg. REACH registered substances
TCSI Taiwan Chemical Substance Inventory
TSCA Toxic Substance Control Act

15.2 Chemical Safety Assessment

Chemical safety assessments for substances in this mixture were not carried out.

SECTION 16: Other information

Abbreviations and acronyms
Abbr. Descriptions of used abbreviations

2000/39/EC Commission Directive establishing a first list of indicative occupational exposure limit values in imple-
mentation of Council Directive 98/24/EC

Acute Tox. Acute toxicity

ADN Accord européen relatif au transport international des marchandises dangereuses par voies de naviga-
tion intérieures (European Agreement concerning the International Carriage of Dangerous Goods by In-
land Waterways)

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

ADR/RID/ADN Agreements concerning the International Carriage of Dangerous Goods by Road/Rail/Inland Waterways
(ADR/RID/ADN)

ATE Acute Toxicity Estimate

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Fatty acid methyl ester mixture ROTICHROM® ME 13

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Abbr. Descriptions of used abbreviations

BCF Bioconcentration factor

BOD Biochemical Oxygen Demand

CAP. 424 Occupational Health and Safety Authority Act (CAP. 424)

Carc. Carcinogenicity

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

Ceiling-C Ceiling value

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

COD Chemical oxygen demand

DGR Dangerous Goods Regulations (see IATA/DGR)

DNEL Derived No-Effect Level

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 identi-
fier of substances commercially available within the EU (European Union)

EINECS European Inventory of Existing Commercial Chemical Substances

ELINCS European List of Notified Chemical Substances

EmS Emergency Schedule

ErC50 ≡ EC50: in this method, that concentration of test substance which results in a 50 % reduction in either
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 Na-
tions

IARC International Agency for Research on Cancer

IATA International Air Transport Association

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

ICAO International Civil Aviation Organization

ICAO-TI Technical instructions for the safe transport of dangerous goods by air

IMDG International Maritime Dangerous Goods Code

IMDG-Code International Maritime Dangerous Goods Code

index No The Index number is the identification code given to the substance in Part 3 of Annex VI to Regulation
(EC) No 1272/2008

IOELV Indicative occupational exposure limit value

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

log KOW n-Octanol/water

NLP No-Longer Polymer

PBT Persistent, Bioaccumulative and Toxic

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Fatty acid methyl ester mixture ROTICHROM® ME 13

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Abbr. Descriptions of used abbreviations

PNEC Predicted No-Effect Concentration

ppm Parts per million

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

Repr. Reproductive toxicity

RID Règlement concernant le transport International ferroviaire des marchandises Dangereuses (Regula-
tions concerning the International carriage of Dangerous goods by Rail)

Skin Corr. Corrosive to skin

Skin Irrit. Irritant to skin

STEL Short-term exposure limit

STOT RE Specific target organ toxicity - repeated exposure

SVHC Substance of Very High Concern

TWA Time-weighted average

VOC Volatile Organic Compounds

vPvB Very Persistent and very Bioaccumulative

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 Mari-
time Dangerous Goods Code (IMDG). Dangerous Goods Regulations (DGR) for the air transport (IATA).
Classification procedure
Physical and chemical properties. The classification is based on tested mixture.
Health hazards. Environmental hazards. The method for classification of the mixture is based on in-
gredients of the mixture (additivity formula).
List of relevant phrases (code and full text as stated in chapter 2 and 3)
Code Text

H302 Harmful if swallowed.

H315 Causes skin irritation.

H319 Causes serious eye irritation.

H331 Toxic if inhaled.

H351 Suspected of causing cancer.

H361d Suspected of damaging the unborn child.

H372 Causes damage to organs through prolonged or repeated exposure.

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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