Safety Data Sheet

CSDS-Caries Status Disclosing Solution

Date: 11 February 2018

1. IDENTIFICATION

Product name: CSDS-Caries Status Disclosing Solution

Company Identification:

Medical Manufacturers Medical Manufacturers Europe Co Ltd Axxess Corporate Park St Mary’s House Unit 131, 45 Gilby Road Netherhampton MT Waverley Vic 3149 Salisbury Wiltshire SP2 8PU Australia UK
Tel: +61 3 9558 6334
Tel: +44 7831 429245
For information call: Sales office +61 2 9557 6704
Emergency Number: +61 425 329 616
Product Use: Dental, disclosing solution for determining whether an open lesion in primary teeth is progressing or static
Limitations: For use by dental professionals

2. HAZARD IDENTIFICATION

Note: Unless otherwise stated SDS data for CSDS applies to both Bottle A and Bottle B.

Signal word: Warning

GHS Classification:

• Skin irritation (Category 2) – H315
• Eye irritation (Category 2A) – H319
• Acute aquatic toxicity (Category 1) – H400
• Chronic aquatic toxicity (Category 1) – H410

Hazard statement(s):
H315 – Causes skin irritation.
H319 – Causes serious eye irritation
H410 – Very toxic to aquatic life with long lasting effects.
P102 - Keep out of reach of children.
P264 - Wash hands thoroughly after handling.
P280 - Wear protective clthing, gloves and eye/face protection.
P301+P330+P331 - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353 - IF ON SKIN: Remove affected clothing. Wash site with plenty of soap and water.
P305+P351+P338 - IF IN EYES: Rinse carefully with water for several minutes after removing any contact lens if present. Continue rinsing.
P337 + P 313 - If eye irritation persists get medical advice/attention.
P405 - Store locked up.
P501 - Dispose of contents according to local regulations.

3. COMPOSITION/INFORMATION ON HAZARDOUS INGREDIENTS

Bottle A:

Bottle B:

Silver fluoride and stannous fluoride Danger 1B; H314 Skin burns and eye damage Warning 4 H302 Harmful if swallowed Warning H410 Very toxic to aquatic life with long- lasting effects.

4. FIRST AID MEASURES

4.1 Description of first aid measures

• Eye Contact: Check for and remove contact lenses. Immediately flush eyes with copious amounts of water. Get immediate medical attention if irritation persists.
• Skin Contact: Remove contaminated clothing and wash contact area with mild soap and copious amounts of water. Get medical attention if irritation develops.
• Inhalation: If inhaled, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms worsen.
• Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as collar, tie, belt or waistband. Get immediate medical attention.

4.2 Most important symptoms and effects, both acute and delayed

See section 2.2 and 11.

4.3 Indication of any immediate medical attention and special treatment needed

No data available

5. FIRE FIGHTING MEASURES

5.1 Extinguishing Media:

Extinguish fire using water spray, carbon dioxide, chemical foam, or dry chemical.

5.2 Special hazards arising from the substance or mixture:

None known

5.3 Advice for firefighters:

As with any fire, wear personal protection equipment, including a self-contained breathing apparatus (S.C.B.A.)

6. ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment and emergency procedures

Wear chemical resistant clothing, gloves, and eye protection. Wear NIOSH/MSHA approved breathing apparatus.

6.2 Environmental precautions

Keep material away from heat, flame, ignition sources, and reactive materials. Don’t allow product to enter drain.

6.3 Methods and materials for containment and cleaning up

Wipe up or absorb spill using inert absorbent and place in a suitable waste container for disposal.

7. HANDLING AND STORAGE

7.1 Precautions for safe handling.

Avoid contact with skin and eyes. Wash thoroughly after handling. Avoid breathing vapor.

7.2 Conditions for safe storage, including any incompatibilities.

Store in well ventilated area. Keep container tightly closed and locked away. Store at 5-25°C.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Personal Protective Equipment (PPE):

• Eye/Face protection: Safety glasses or goggles are required.
• Skin protection: Protective clothing is required.
• Hand protection: Chemical resistant gloves are required. Dental gloves. Glove material must be resistant to the components of this product. If in doubt, consult glove manufacturer for specific recommendations of appropriate material and thickness of glove.
• Respiratory protection: Avoid breathing vapor.
• Environmental exposure controls: Avoid releasing large quantities into the environment.
• No additional information.

9. PHYSICAL AND CHEMICAL PROPERTIES

• Physical State: Liquid
• Color: Transparent, colourless
• Odor: Unknown
• Odor Threshold: Unknown
• pH: Unknown
• Melting Point/ Freezing Point: Unknown
• Initial Boiling Point: Unknown
• Flash Point: Unknown
• Evaporation Rate: Unknown
• Flammability (solid, gas): Unknown
• Vapor Pressure: Unknown
• Vapor Density: Unknown
• Relative Density: Unknown
• Solubility(ies): Water
• Partition Coefficient: n-octanol/water: Unknown
• Auto-Ignition Temperature: Unknown
• Decomposition Temperature: Unknown
• Viscosity: Unknown
• Explosive Properties: Not explosive.
• Oxidizing Properties: Unknown

10. STABILITY AND REACTIVITY

10.1 Reactivity:

No relevant data available.

10.2 Chemical Stability:

Stable under normal temperatures and pressures.

10.3 Possibility of Hazardous Reactions:

No hazardous reactions known.

10.4 Conditions to Avoid:

Fire, static electricity, direct sunlight.

10.5 Incompatible Materials:

Oxidizers, alkalis, antimony salts, arsenates, carbonates and phosphates.

10.6 Hazardous Decomposition Materials:

Carbon oxides, nitrogen oxides, oxides of silver

11. TOXICOLOGICAL INFORMATION (cont)

Respiratory or skin sensitization.

No relevant data available.

Germ Cell Mutagenicity.

No relevant data available.

Carcinogenicity.

International Agency for Research on Cancer (IARC). None of the components are listed.
National Toxicology Program (NTP). None of the components are listed.

12. ECOLOGICAL INFORMATION

Toxicity:

• Fish: No relevant studies identified.
• Crustacea: No relevant studies identified.
• Algae/Aquatic Plants: No relevant studies identified.
• Other Organisms: No relevant studies identified.
  Persistence and Degradability: No relevant studies identified.
  Bioaccumulative Potential: No relevant studies identified.
  Mobility in Soil: Miscible in water. May spread in water systems. This component is non-volatile.
  Additional Remarks: None.
  Results of PBT and vPvB Assessment: PBT: This mixture does not contain any substances that are assessed to be a PBT.
  vPvB: This mixture does not contain any substances that are assessed to be a vPvB.

13. DISPOSAL CONSIDERATIONS

Waste disposal methods:

Sewage disposal is discouraged. Waste should not be disposed of by release to sewers. Dispose waste in accordance with federal, state and local environmental control regulations.
Product/packaging disposal: Final decisions on the appropriate waste management method must be in line with local, regional and national regulations.

14. TRANSPORT INFORMATION

Silver fluoride:

• UN Number: 2923
• Class: 8

Stannous fluoride:

• UN Number: 2811
• Class: 6.1

For transport CSDS can be considered as a Chemical Kit UN3316 Class M11 if all IATA criteria are complied with.

15. Regulatory Information

This product is regulated by the TGA and has approval for sale in Australia and selected overseas countries.