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SAFETY DATA SHEET

SAFETY DATA SHEET

SAFETY DATA SHEET

Product catalog summary

1. Identification of the Substance and Supplier

Product: Burnfree (Burn gel for first aid treatment)

Supplier: AKLA AB, Danderyd, Sweden. Contact: Eva Janmark, Phone: +46 (0)8-446 47 30, Email: [email protected]

Emergency Contact: Emergency telephone 112; Poison information available via WHO IPCS directory.

2. Hazard Identification

The product is not classified as dangerous under Swedish and EU regulations (KIFS 2005:7, 67/548/EEC). However, misuse or large quantities may cause harm to humans or the environment. Use only as intended and contact the manufacturer if adverse effects are suspected.

3. Composition and Ingredients

The product is a mixture primarily composed of:

  • Water: 90-100%, no hazard classification.
  • Tea Tree Oil: 0.5-0.99%, classified as harmful and dangerous for the environment with hazard statements including flammability, toxicity if swallowed, respiratory and skin irritation, sensitization, and aquatic toxicity.

Labelling follows both 67/548/EEG and GHS/CLP regulations with detailed hazard codes provided.

4. First Aid Measures

  • Inhalation: Flush nose, mouth, throat with water if exposed to smoke or dust; seek medical advice if symptoms occur.
  • Eye Contact: Rinse eyes with water; consult physician if irritation persists.
  • Skin Contact: Wash skin normally; remove contaminated clothing; seek medical advice if symptoms develop.
  • Ingestion: Induce vomiting as a precaution and contact a physician.

5. Firefighting Measures

  • Product is not flammable or oxidizing.
  • Extinguish fires using agents suitable for surrounding materials.
  • Burning may emit harmful gases such as carbon monoxide, carbon dioxide, aldehydes.
  • Firefighters should use self-contained breathing apparatus.

6. Accidental Release Measures

  • Avoid release into soil, water, or air.
  • In case of spill near protected water sources, call emergency services immediately.
  • Use allergy-tested gloves and possibly dust filter masks (P2) during cleanup.
  • Collect spilled material for combustion disposal; rinse area with water; avoid airborne dispersion.
  • Dispose of contaminated product as chemical waste, not classified as dangerous goods.

7. Handling and Storage

  • Keep out of reach of children and pets.
  • Store in well-ventilated areas below normal room temperature and away from food products.
  • Do not eat, drink, or smoke where the product is stored or handled.

8. Exposure Controls and Personal Protection

  • Exposure Limits: Ethanol (500 ppm TWA), Triethanolamine (5 mg/m3 TWA).
  • Use adequate ventilation.
  • Wear normal work clothing; wash contaminated clothing immediately.
  • Eye protection (safety glasses/goggles/face shield) recommended if risk of splashes exists.
  • Respiratory protection only needed in extreme conditions; dust filter P2 may be used.

9. Physical and Chemical Properties

  • Appearance: Gel, paste, or cream.
  • pH: 4-7 (undiluted).
  • Not flammable; no explosive properties.

10. Stability and Reactivity

The product is chemically stable under normal conditions.

11. Toxicological Information

  • Not classified as toxic or harmful.
  • No known chronic, carcinogenic, mutagenic, or reproductive toxicity effects.
  • May cause minor irritation or sensitization in sensitive individuals.
  • No known effects on judgment or human microflora.

12. Ecological Information

  • Contains biodegradable, naturally occurring substances with negligible global environmental impact.
  • Local ecological effects possible with large emissions.
  • Does not bioaccumulate.

13. Disposal Considerations

  • Not classified as dangerous waste.
  • Follow local regulations for waste disposal.
  • Not typically recycled.

14. Transport Information

Not classified as dangerous goods for transport.

15. Regulatory Information

  • No risk phrases or danger symbols assigned.
  • Certified as a medical device under MDD 93/42/EEC and FDA (510k).

16. Other Information

  • Misuse can cause injury; manufacturer not responsible for improper use.
  • Detailed hazard phrase explanations provided for Tea Tree Oil components.
  • Document generated using KemRisk® software.
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Catalog excerpts

SAFETY DATA SHEET-1

SAFETY DATA SHEET According to 67/548/EEG and 1272/2008/EG (GHS/CLP) Safety data sheet no 5. Edition 2011-03-02. Recalculated to GHS/CLP 2011-03-03. SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Trade name Burnfree National product identifier 2 1.2. Relevant identified uses of the substance or mixture and uses advised against Identified uses Burn gel for first aid treatment Assessment and chemical safety report according to REACH Bilaga I has not been performed. 1.3. Details of the supplier of the safety data sheet Company AKLA AB Box 534 18215 DANDERYD Contact person Eva Janmark Telephone +46 (0)8-446 47 30 E-Mail [email protected] 1.4. Emergency telephone number In case of emergency contact toxicological information, emergency tel 112 For non-emergency poison information, see http://www.who.int/ipcs/poisons/centre/directory/euro/en/ SECTION 2: HAZARDS IDENTIFICATION Not classified according to KIFS 2005:7. The Swedish National substance Inspectorates regulations about classification and labelling of substance products, 12 §. The product is not classified as dangerous according to 67/548/EEC. Note that also products which do not fulfil the criteria for being dangerous may cause harm to humans and the environment if they are misused or used in great quantities C.f. section 16 for advise on the correct handling of this product. Immediately contact the manufacturer if the product is suspected to cause harm. Important advice for safe handling This product is not classified as dangerous but all chemicals may, if used in great quantities or in high concentrations, be harmful for humans and environment. It shall only be used for intended purpose. Contact the manufacturer if any harm is suspected. SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS The article is composed of a mixture of several substances. Labelling according to 67/548/EEG Chemical name EG No CAS No Conc Danger symbol(s) WATER 231-791-2 7732-18-5 90 - 100% *; TEA TREE OIL 68647-73-4 0,5 - 0,99% Xn N; R10 R22 R36/37/38 R43 R51/53 R65 Classification: *: No labelling; C: Corrosive: E: Explosive; F+: Extremely flammable; F: Highly flammable; N: Dangerous for the environment; O: Oxidising; R: Radioactive; T: Toxic; T+: Very toxic; Xn: Harmful; Xi: Irritating; V: Caution - substance not yet fully tested; NOMEN OBLITUM: Unspecified, in the context harmless, substance. Safety data sheet for Burnfree. Edition 2011-03-02

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SAFETY DATA SHEET-2

Labelling according to 1272/2008/EG (GHS/CLP) Chemical name Danger symbol(s) NP; NH; NE WATER Warning H226; TEA TREE OIL Complete explanation to hazard pictograms and hazard statements according to GHS/CLP, c.f. section 16. NP, NH, and NE means that the product has been assessed with respect to physical, health, and environmental hazards respectively and not classified as hazardous This product contains substances that do not require labelling SECTION 4: FIRST AID MEASURES Generally No special measures should be needed; If nevertheless symptoms should occur, contact physician. On breathing On...

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SAFETY DATA SHEET-3

Environmental precautions The product can be released into the environment in the amounts that may possibly be in use. methods for cleaning up Carefully gather the material for waste combustion; Then rinse spillage area with water. Avoid raising the material into the air. Other information Contaminated product shall be handled as chemical waste and should be declared as not dangerous goods. SECTION 7: HANDLING AND STORAGE General advises for handling and storage This product shall be kept out of reach for young children and securely separated from products intended for ingestion. Demands for...

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SAFETY DATA SHEET-4

Respiratory protection Breathing protection shall only be needed in extreme working situations. Consult the manufacturer if that is the case. Dust filter IIb(P2) may be needed. Hand protection Not indicated Eye protection Use safety glasses, safety goggles, face-shield. Eye protection shall be used in case of risk for direct contact or splashes. Skin protection Not indicated Environmental exposure controls For limitation of environmental exposure, see section 12. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES General information Appearance Gel State of aggregation Paste, salve, cream Legislation...

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SAFETY DATA SHEET-5

sensitisation Hypersensitivity reactions cannot be excluded for sensitive persons. Corrosive and irritating effects The product is not corrosive. Minor irritation cannot be excluded for sensitive persons. Other toxicologic information. Synergism and antagonism As far as we know no synergistic effects have been reported for this product or any of its ingredients. Effect on judgement and other psychic effects As far as we know this product does not affect the judgement if used as intended. Effect on the human micro flora Effects on the micro flora of humans is unproven or negligible. SECTION 12:...

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SAFETY DATA SHEET-6

SECTION 15: REGULATORY INFORMATION Risk phrases*) R0 This product is considered not to be attributed any R phrase or any other risk information Danger symbol(s) This product has been judged and it shall not have any symbol of danger Other information CE-märkt Medicinteknisk produkt. Uppfyller kraven enligt MDD 93/42/EEC. FDA(510k). SECTION 16: OTHER INFORMATION Warning for misuse This product can cause injuries if not used properly. The manufacturer, the distributor or the supplier cannot be responsible for adverse effects if the product is not handled in accordance with its intended use. Full...

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