Supelco Phenolphthalein Indicator ACS, Reag. Ph Eur

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

1.1 Product identifiers

Product Name: Phenolphthalein indicator ACS, Reag. Ph Eur

Product Number: 1.07233

Catalogue Number: 107233

Brand: Millipore

Index No.: 604-076-00-1

REACH No.: 01-2119498295-24-XXXX

CAS No.: 77-09-8

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

Identified uses: Reagent for analysis

1.3 Information on the supplier of the safety data sheet

Company: BIOTECHA Eesti OÜ

Liimi 1

10621 TALLINN

ESTONIA

Email: TechnicalService@merckgroup.com

1.4 Emergency telephone number

Emergency telephone #: 16662 (Poison Control Center)

+372 668 1294 (CHEMTREC)

Please contact your regional Merck representative for assistance in your country.

Section 2: Hazards identification

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008):

• Skin irritation, Category 2 (H315: Causes skin irritation.)
• Germ cell mutagenicity, Category 2 (H341: Suspected of causing genetic defects.)
• Carcinogenicity, Category 1B (H350: May cause cancer.)
• Reproductive toxicity, Category 2 (H361f: Suspected of damaging fertility.)

2.2 Label elements

Labelling (REGULATION (EC) No 1272/2008):

Hazard pictograms: ⚠️

Signal word: Warning

Hazard statements:

• H315: Causes skin irritation.
• H341: Suspected of causing genetic defects.
• H350: May cause cancer.
• H361f: Suspected of damaging fertility.

Precautionary statements:

• P202: Do not handle until all safety precautions have been read and understood.
• P264: Wash skin thoroughly after handling.
• P280: Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response:

• P302 + P352: IF ON SKIN: Wash with plenty of water.
• P308 + P313: If exposed or concerned: Get medical advice/ attention.
• P332 + P313: If skin irritation occurs: Get medical advice/ attention.

2.3 Other hazards

The substance/mixture does not contain components considered to be persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) at a concentration of 0.1% or more.

Ecological information: The substance/mixture does not contain components that are suspected of causing endocrine disruption according to Article 57(f) of REACH, Regulation (EU) 2017/2100 or Commission Delegated Regulation (EU) 2018/605 at a concentration of 0.1% or more.

Information on toxicity: The substance/mixture does not contain components that are suspected of causing endocrine disruption according to Article 57(f) of REACH, Regulation (EU) 2017/2100 or Commission Delegated Regulation (EU) 2018/605 at a concentration of 0.1% or more.

Section 3: Composition/information on ingredients

3.1 Substances

Index No.: 604-076-00-1

EC No.: 201-004-7

Section 4: First aid measures

4.1 Description of first aid measures

General advice: Show this safety data sheet to the doctor.

If inhaled: Move to fresh air. Call a doctor.

In case of skin contact:

• Skin contact: Take off all contaminated clothing immediately. Wash off with plenty of water/shower. Consult a doctor.

In case of eye contact:

• Eye contact: Rinse with plenty of water. Call an ophthalmologist (eye doctor). Remove contact lenses.

If swallowed: Rinse mouth. Give water to drink (at least two glasses). Consult a doctor.

4.2 Most important symptoms and effects, both acute and delayed

The most important symptoms and effects are described in marking (see section 2.2) or section 11.

4.3 Indication of any immediate medical attention and special treatment needed

No data available.

Section 5: Firefighting measures

5.1 Extinguishing media

Suitable extinguishing media: Water, Foam, Carbon dioxide (CO2), Dry powder

Unsuitable extinguishing media: No restrictions are given for the extinguishing agents for this substance/mixture.

5.2 Special hazards arising from the substance or mixture

Main hazards arising from the substance during fire: Combustible.

Product hazards during combustion: Hazardous combustion gases or vapors may form during a fire.

Carbon oxides

5.3 Advice for firefighters

Special protective equipment for firefighters: Only wear self-contained breathing apparatus in the danger zone. Avoid contact with skin and protective clothing.

Further information: Avoid contamination of surface water and groundwater with fire extinguishing water.

Section 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Personal precautions: Advice for non-emergency personnel.

• Avoid creating dust and inhalation under any circumstances.
• Avoid contact with the substance.
• Ensure adequate ventilation.
• Evacuate the danger area, follow emergency procedures, consult an expert.

Protective measures are in Section 8.

6.2 Environmental precautions

Environmental precautions: Do not pour product into drains.

6.3 Methods and material for containment and cleaning up

Cleaning methods: Cover drains. Collect spilled substance, bind and pump away. Observe possible material restrictions (see sections 7 and 10). Collect carefully. Dispose of properly. Decontaminate the affected area. Avoid dust formation.

References to other sections: For disposal instructions see Section 13.

Section 7: Handling and storage

7.1 Precautions for safe handling, including any incompatibilities

Recommendations for safe handling: Work under local exhaust ventilation. Do not inhale the substance/mixture.

Hygiene measures: Remove contaminated clothing immediately. Wear preventative skin protection. Wash hands and face after working with the substance.

Precautions are listed in Section 2.2.

7.2 Conditions for safe storage, including any incompatibilities

Information on storage conditions: Keep tightly closed. Dry. Store in a well-ventilated place. Store locked up or in an area accessible only to qualified and authorized personnel.

German storage class (TRGS 510): 6.1C, Combustible, Category 3 causing acute toxicity / highly toxic material or compound causing chronic damage

Further information on stability: Recommended storage temperature, see product label.

7.3 Specific end use(s)

Some uses are listed in Section 1.2, other specific uses are not defined.

Section 8: Exposure controls/personal protection

8.1 Control parameters

Occupational exposure limits: Does not contain substances for which occupational exposure limits are set.

8.2 Exposure controls

Personal protective equipment:

• Eye/face protection: Wear eye protection that has been tested and approved according to the or EN 166(EU). Safety glasses.
• Hand protection:
  • Material: Nitrile rubber
  • Permeation time: 480 min
  • Glove thickness: 0.11 mm
  • Index of protection: Full contact
  • Manufacturer: KCL 741 Dermatril® L
• Material: Nitrile rubber
• Permeation time: 480 min
• Glove thickness: 0.11 mm
• Index of protection: Splash contact
• Manufacturer: KCL 741 Dermatril® L

Remarks: This recommendation applies only to the product supplied for its intended use as described on the safety data sheet. For dissolution or mixing under conditions different from those stated in EN 16523-1, please contact the CE-approved glove supplier (e.g., KCL GmbH, D-36124 Eichenzell, Internet: www.kcl.de).

Skin and body protection: Protective clothing.

Respiratory protection: Required when dust is generated.

Our recommendations for respiratory protection filters are based on the following standards: DIN EN 143, DIN 14387 and other relevant standards applicable to respiratory protection systems.

Recommended filter type: P3 type filter

The employer must ensure the maintenance, cleaning, and proper documentation of respiratory protective equipment.

Environmental exposure controls: Do not pour product into drains.

Section 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

Physical state: Solid

Color, appearance: White

Odor: Odorless

Odor threshold: Not applicable

Melting point: approx. 263.7 °C (approx. 1.013 hPa) Method: OECD Test Guideline 102 GLP: yes

Boiling point/boiling range: > 450 °C (1.013 hPa) Method: OECD Test Guideline 103

Flammability: Method: Combustible (solids) Remarks: The product is not flammable.

Upper/lower flammability or explosive limits: Data not available

Flash point: Not applicable

Auto-ignition temperature: Data not available

Decomposition temperature: Data not available

pH: Data not available

Viscosity, dynamic: Data not available

Viscosity, kinematic: Data not available

Flow time: Data not available

Solubility(ies):

• Water solubility: 0.00336 g/l (20 °C) pH: 5.8 - 6.1 Method: OECD Test Guideline 105 Slightly soluble

Partition coefficient (n-octanol/water): log Pow: 0.9 (25 °C) pH: 6.6 Method: OECD Test Guideline 117 Bioaccumulation is not expected.

Vapor pressure: < 0.1 hPa (50 °C) Method: OECD Test Guideline 104 GLP: yes

Relative density: approx. 1.29 (20.6 °C) Method: OECD Test Guideline 109

Density: Data not available

Bulk density: 350 - 450 kg/m3

Relative vapor density: Data not available

Particle characteristics:

• Particle size: 56.6 μm Method: OECD Test Guideline 110

Section 9.2 Other information

Explosives: Not classified as an explosive substance.

Oxidizing properties: None

Flammability rate: Data not available

Self-ignition: 397 °C Method: Relative self-ignition temperature of solids

Evaporation rate: Data not available

Surface tension: 71.8 mN/m, 20 °C, OECD Test Guideline 115

Molecular mass: 318.33 g/mol

Section 10: Stability and reactivity

10.1 Reactivity

The following applies to combustible organic substances and mixtures in general: explosion hazard is to be assumed.

10.2 Chemical stability

The product is chemically stable under standard ambient conditions (room temperature).

10.3 Possibility of hazardous reactions

Hazardous reactions: Possible violent reaction with the following:

• Strong oxidizing agents

10.4 Conditions to avoid

Conditions to avoid: Information not available

10.5 Incompatible materials

Materials to avoid: Strong oxidizing agents

10.6 Hazardous decomposition products

Hazardous decomposition products in case of fire: See Section 5.

Section 11: Toxicological information

11.1 Information on toxicological effects

Acute toxicity:

• Oral: Data not available
• Inhalation: Data not available
• Dermal: Data not available

Skin corrosion/irritation:

• Skin - reconstructed human epidermis (RhE)
• Result: Irritant - 42 min (OECD Test Guideline 439)

Serious eye damage/irritation:

• Eyes - In vitro study
• Result: Non-corrosive - 4 h (OECD Test Guideline 437)

Respiratory or skin sensitization:

• Respiratory or skin sensitization
• Local lymph node assay (LLNA) - Mouse
• Result: Does not sensitize the skin. (OECD Test Guideline 429)

Germ cell mutagenicity: Suspected of causing genetic defects.

• Test type: Ames test
• Test system: Salmonella typhimurium
• Metabolic activation: with or without metabolic activation
• Method: OECD Test Guideline 471
• Result: negative

Carcinogenicity: Suspected of causing cancer in humans.

Reproductive toxicity: Suspected of damaging fertility.

Specific target organ toxicity - single exposure: Data not available

Specific target organ toxicity - repeated exposure: Data not available

Aspiration hazard: Data not available

11.2 Further information

Endocrine disrupting properties:

• Product:
• Assessment: The substance/mixture does not contain components that are suspected of causing endocrine disruption to the environment according to Article 57(f) of REACH, Regulation (EU) 2017/2100 or Commission Delegated Regulation (EU) 2018/605 at a concentration of 0.1% or more.

Chronic toxicity - Rat - male and female - Oral - 13 Weeks - Dose, if no observable effect level yet - 800 mg/kg

To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated.

In case of large quantities:

• Nausea
• Vomiting
• Indigestion
• Fever
• Heart disorders
• Central nervous system disorders

The substance has a laxative effect.

Other harmful properties cannot be excluded.

This substance must be handled with particular caution.

Section 12: Ecological information

12.1 Toxicity

Components, parts:

Phenolphthalein:

• Toxic effect on Daphnia (water flea) and other aquatic invertebrates: EC50 (Daphnia magna): > 100 mg/l Result indicator: Immobilization Exposure time: 48 h Test type: Static test Analytical monitoring: yes Method: OECD Test Guideline 202 GLP: yes
• Toxicity to algae/aquatic plants: ErC50 (Desmodesmus subspicatus (green algae)): > 3.33 mg/l Exposure time: 72 h Test type: Static test Method: OECD Test Guideline 201 GLP: yes
• NOEC (Desmodesmus subspicatus (green algae)): 0.57 mg/l Exposure time: 72 h Test type: Static test Method: OECD Test Guideline 201 GLP: yes

Ecotoxicological assessment:

• Hazardous to the aquatic environment, acute toxicity: The product has no known ecotoxicological effects.
• Hazardous to the aquatic environment, chronic toxicity: The product has no known ecotoxicological effects.

Section 12.2 Persistence and degradability

Components, parts:

Phenolphthalein:

• Biodegradation: Test type: aerobic Inoculum: activated sludge, not adapted Concentration: 105 mg/l Result: Readily biodegradable. Biodegradation: 76% Exposure time: 28 d Method: OECD Test Guideline 301F GLP: yes Remarks: The 10-day timeframe criterion was not met.

Section 12.3 Bioaccumulation

Components, parts:

Phenolphthalein:

• Partition coefficient (n-octanol/water): log Pow: 0.9 (25 °C) pH: 6.6 Method: OECD Test Guideline 117 Remarks: Bioaccumulation is not expected.

Section 12.4 Mobility in soil

Data not available

Section 12.5 Persistence, bioaccumulative and toxic properties and very persistent and very bioaccumulative properties assessment

Product:

• Assessment: The substance/mixture does not contain components considered to be persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) at a concentration of 0.1% or more.

Section 12.6 Endocrine disrupting properties

Product:

• Assessment: The substance/mixture does not contain components that are suspected of causing endocrine disruption.

Section 12.7 Other adverse effects

Components, parts:

Phenolphthalein:

• Ecological information: Data not available

Section 13: Disposal considerations

13.1 Waste treatment methods

Product: Waste must be disposed of in accordance with national and local regulations. Keep chemicals in original containers. Keep separate from other waste. Treat uncleaned containers as the product itself. For reference, Waste Directive 2008/98/EC.

Section 14: Transport information

14.1 UN number or ID number

• ADR: Not classified as dangerous goods
• IMDG: Not classified as dangerous goods
• IATA_P: Not classified as dangerous goods

14.2 UN proper shipping name

• ADR: Not classified as dangerous goods
• IMDG: Not classified as dangerous goods
• IATA_P: Not classified as dangerous goods

14.3 Transport hazard class(es)

• ADR: Not classified as dangerous goods
• IMDG: Not classified as dangerous goods
• IATA_P: Not classified as dangerous goods

14.4 Packing group

• ADR: Not classified as dangerous goods
• IMDG: Not classified as dangerous goods
• IATA (Cargo): Not classified as dangerous goods
• IATA_P (Passenger): Not classified as dangerous goods

14.5 Environmental hazards

Not classified as dangerous goods

14.6 Special precautions for user

Remarks: According to transport regulations, it is not classified as a dangerous substance.

14.7 Maritime transport in bulk according to Annex II of MARPOL and the IBC Code

Not applicable to the product supplied.

Section 15: Regulatory information

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

REACH - Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles (Annex XVII):

• The following restrictions must be taken into account: Entry number 28: Phenolphthalein
• Entry number 75: If you intend to use this product as tattoo ink, please contact your supplier.

REACH - Candidate List of Substances of Very High Concern (Article 59): Phenolphthalein

Regulation (EU) No 2024/590 on substances that deplete the ozone layer (recast): Not applicable

Regulation (EU) 2019/1021 on persistent organic pollutants (recast): Not applicable

REACH - List of substances subject to authorization (Annex XIV): Not applicable

Seveso III: Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances, amending and repealing Council Directive 96/82/EEC and its subsequent amendments: Not applicable

15.2 Chemical safety assessment

A chemical safety assessment has not been carried out for the substance.

Section 16: Other information

Full text of other abbreviations and acronyms

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - European Agreement concerning the International Carriage of Dangerous Goods by Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for Testing and Materials; bw - body weight; CLP - Classification, Labelling and Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogenic, Mutagenic or toxic to Reproduction; DIN - German Institute for Standardization; DSL - Domestic Substances List (Canada); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Concentration of the test substance that causes an effect x% of the observed response; ELx - Loading rate that causes an effect x% of the observed response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration of the test substance that causes an effect x% of the growth rate; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships Carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods Code; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organization for Standardization; KECI - Korean Existing Chemicals Inventory; LC50 - Lethal Concentration to 50% of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - not otherwise specified; NO(A)EC - Observed (or expected) no-effect concentration; NO(A)EL - Observed (or expected) no-effect level; NOELR - No observed effect level reporting; NZIoC - New Zealand Inventory of Chemicals; OECD - Organisation for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippine Inventory of Chemicals and Chemical Substances; (Q)SAR - Quantitative Structure-Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI - Taiwan Existing Chemical Inventory; TRGS - Technical Rules for Hazardous Substances; TSCA - Toxic Substances Control Act (USA); UN - United Nations Organization; vPvB - very Persistent and very Bioaccumulative substance

Further information

The information provided in this document is believed to be accurate, but it is not exhaustive and should be used as a guide only. The information provided in this document is based on our current level of knowledge and applies to the product in relation to the appropriate safety measures. It does not constitute any guarantee of the product's properties. Sigma-Aldrich Co. is not liable for any damages caused by the handling or contact with the product described above. For further terms of sale, see the invoice or the back of the delivery note.

Copyright 2020 Sigma-Aldrich Co. LLC. Permission is granted to make unlimited paper copies for internal use only.