GEL ULTRASUONI TRASPARENTE - bustina 20ml STERILE
GEL ULTRASUONI TRASPARENTE - bustina 20ml STERILE
Codice: Categoria:
Unità di vendita: Quantitativi minimi:
33269
Gel ultrasuoni conf. 48 pz.
1
Dispositivo: Dispositivo medico
Classe: II A
NSIS: 555062
CND: V9099
EAN13: 8698712450286
Descrizione:
Ipoallergenico, adatto a tutti i tipi di applicazione in ambito ecografico e doppler. Assicura una corretta propagazione delle onde agli apparecchi e garantisce una chiara e continua visualizzazione delle immagini. Privo di sale, formaldeide e fragranze, la sua composizione non danneggia le sonde.
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Tel. 000 000 000 - Fax 000 000 000
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier
Product form | : | Mixture |
Product name | : | Sterile Ultrasound Gel |
1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Use of the substance/mixture | : | Ultrasound gel |
1.2.2. Uses advised against
No additional information available
1.3. Details of the supplier of the safety data sheet
Turkuaz Sağlık Hizmetleri San. ve Tic. A.Ş.
Beysan Sanayi Sitesi. Birlik caddesi. No:32/1 Beylikdüzü / istanbul Turkey
T x00 000 000 00 00 - F x00 000 000 00 00
xxxx@xxxxxxxxxxxxx.xxx.xx - xxx.xxxxxxxxxxxxx.xxx.xx
1.4. Emergency telephone number
Emergency number | : | x00 000 000 00 00 |
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP], Globally Harmonized System [GHS] and Work Health and Safety Regulations, Schedule 6
Not classified
Adverse physicochemical, human health and environmental effects
To our knowledge, this product does not present any particular risk, provided it is handled in accordance with good occupational hygiene and safety practice.
2.2. Label elements
Labelling according to Regulation (EC) No. 1272/2008 [CLP], Globally Harmonized System [GHS] and Work Health and Safety Regulations, Schedule 6
No labelling applicable
2.3. Other hazards
No additional information available
SECTION 3: Composition/information on ingredients
3.1. Substance
Not applicable
3.2. Mixture
Name | Product identifier | % | Classification according to CLP, GHS & WHS S.6 |
Aqua | (CAS No) 7732-18-5 (EC no) 000-000-0 | q.s. 100 | Not classified |
Propane-1,2-diol | (CAS No) 57-55-6 (EC no) 000-000-0 | 0.1 - < 1 | Not classified |
Carbomer | (CAS No) 9003-01-4 | 0.1 - < 1 | Not classified |
Sodium Hydroxide % 48 | (CAS No) 1310-73-2 | 0.1- < 1 | Acute Tox. 4 (Dermal), H312 Skin Corr. 1A, H314 Eye Dam. 1, H318 Aquatic Acute 3, H402 |
PhenoxyEthanol and EthylHexylGlycerin | Cas No:122-99-6 Cas No: 00000-00-0 | 0.5 - < 1,5 | Not classified |
Full text of H-statements: see section 16
SECTION 4: First aid measures
4.1. Description of first aid measures
First-aid measures after inhalation | : | Remove person to fresh air and keep comfortable for breathing. |
First-aid measures after skin contact | : | Wash skin with plenty of water. |
First-aid measures after eye contact | : | Rinse eyes with water as a precaution. |
First-aid measures after ingestion | : | Call a poison center or a doctor if you feel unwell. |
4.2. Most important symptoms and effects, both acute and delayed
No additional information available
4.3. Indication of any immediate medical attention and special treatment needed
Treat symptomatically.
SECTION 5: Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media | : | Water spray. Dry powder. Foam. Carbon dioxide. |
5.2. Special hazards arising from the substance or mixture
Hazardous decomposition products in case of fire; | : | Toxic fumes may be released. |
5.3. Advice for firefighters
Protection during firefighting | : | Do not attempt to take action without suitable protective equipment. Self- contained breathing apparatus. Complete protective clothing. |
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
6.1.1. For non-emergency personnel
Emergency procedures | : | Ventilate spillage area. |
6.1.2. For emergency responders
Protective equipment | : | Do not attempt to take action without suitable protective equipment. For further information refer to section 8: "Exposure controls/personal protection". |
6.2. Environmental precautions
Avoid release to the environment.
6.3. Methods and material for containment and cleaning up
Methods for cleaning up | : | Take up liquid spill into absorbent material. |
Other information | : | Dispose of materials or solid residues at an authorized site. |
6.4. Reference to other sections
For further information refer to section 13.
SECTION 7: Handling and storage
7.1. Precautions for safe handling
Precautions for safe handling | : | Ensure good ventilation of the work station. Wear personal protective equipment. |
Hygiene measures | : | Do not eat, drink or smoke when using this product. Always wash hands after handling the product. |
7.2. Conditions for safe storage, including any incompatibilities
Storage conditions | : | Store in a well-ventilated place. Keep cool. Keep away from heat and direct sunlight. |
7.3. Specific end use(s)
No additional information available
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Propane-1,2-diol (57-55-6) | ||
Local name | Propane-1,2-diol | |
WEL TWA (mg/m³) | 10 mg/m³ particulates 474 mg/m³ total vapour and particulates | |
WEL TWA (ppm) | 150 ppm total vapour and particulates | |
8.2. Exposure controls
Appropriate engineering controls: |
Ensure good ventilation of the work station. |
Personal protective equipment: |
Safety glasses. Gloves. |
Hand protection: |
Protective gloves |
Eye protection: |
Safety glasses |
Skin and body protection: |
Wear suitable protective clothing |
Respiratory protection: |
In case of insufficient ventilation, wear suitable respiratory equipment |
Environmental exposure controls: |
Avoid release to the environment. |
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Physical state | : | Liquid |
Appearance | : | Gel. |
Colour | : | Colourless. |
Odour | : | No data available |
Odour threshold | : | No data available |
pH | : | No data available |
Relative evaporation rate (butylacetate=1) | : | No data available |
Melting point | : | Not applicable |
Freezing point | : | No data available |
Boiling point | : | No data available |
Flash point | : | No data available |
Auto-ignition temperature | : | No data available |
Decomposition temperature | : | No data available |
Flammability (solid, gas) | : | Not applicable |
Vapour pressure | : | No data available |
Relative vapour density at 20 °C | : | No data available |
Relative density | : | No data available |
Solubility | : | No data available |
Log Pow | : | No data available |
Viscosity, kinematic | : | No data available |
Viscosity, dynamic | : | No data available |
Explosive properties | : | No data available |
Oxidising properties | : | No data available |
Explosive limits | : | No data available |
9.2. Other information
No additional information available
SECTION 10: Stability and reactivity
10.1. Reactivity
The product is non-reactive under normal conditions of use, storage and transport.
10.2. Chemical stability
Stable under normal conditions.
10.3. Possibility of hazardous reactions
No dangerous reactions known under normal conditions of use.
10.4. Conditions to avoid
None under recommended storage and handling conditions (see section 7).
10.5. Incompatible materials
No additional information available
10.6. Hazardous decomposition products
Under normal conditions of storage and use, hazardous decomposition products should not be produced.
SECTION 11: Toxicological information
11.1. Information on toxicological effects
Acute toxicity | : | Not classified |
Propane-1,2-diol (57-55-6) | |
LD50 oral rat | > 10400 mg/kg |
LD50 dermal rabbit | 20800 mg/kg |
Triethanolamine (102-71-6) | |
LD50 oral rat | > 4000 mg/kg |
LD50 dermal rabbit | > 2000 mg/kg |
Skin corrosion/irritation | : | Not classified |
Serious eye damage/irritation | : | Not classified |
Respiratory or skin sensitisation | : | Not classified |
Germ cell mutagenicity | : | Not classified |
Carcinogenicity | : | Not classified |
Reproductive toxicity | : | Not classified |
Specific target organ toxicity (single exposure) | : | Not classified |
Specific target organ toxicity (repeated exposure) | : | Not classified |
Aspiration hazard | : | Not classified |
SECTION 12: Ecological information
12.1. Toxicity
Ecology - general | : | The product is not considered harmful to aquatic organisms nor to cause long-term adverse effects in the environment. |
Propane-1,2-diol (57-55-6) | |
LC50 fish | 46500 mg/kg (Pimephalas Promelas) |
EC50 daphnia | 43500 (Daphnia Manga) |
EC50 72h algae | 24200 mg/l (Selenastrum Capricornutum) |
Triethanolamine (102-71-6) | |
LC50 fish | > 1000 mg/l (Pimephales Promelas) |
LC50 other aquatic organisms | 525 mg/l (Bacteria - Photobacterium Phosphoreum) |
EC50 daphnia | 1386 (Daphnia Manga) |
EC50 72h algae | 216 mg/l (Scenedesmus Subspicatus) |
12.2. Persistence and degradability
Propane-1,2-diol (57-55-6) | |
Persistence and degradability | Readily biodegradable. |
Triethanolamine (102-71-6) | |
Persistence and degradability | Readily biodegradable. |
12.3. Bioaccumulative potential
Propane-1,2-diol (57-55-6) | |
Log Pow | -0.92 |
Bioaccumulative potential | Not expected to be bioaccumulative. |
Triethanolamine (102-71-6) | |
Bioaccumulative potential | Not bioaccumulable. |
12.4. Mobility in soil
Propane-1,2-diol (57-55-6) | |
Ecology - soil | Soluble in water. Spillages may cause the contamination of ground water by penetrating to the soil. |
Triethanolamine (102-71-6) | |
Ecology - soil | Soluble in water. Spillages may cause the contamination of ground water by penetrating to the soil. |
12.5. Results of PBT and vPvB assessment
No additional information available
12.6. Other adverse effects
No additional information available
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Waste treatment methods | : | Dispose of contents/container in accordance with licensed collector’s sorting instructions. |
SECTION 14: Transport information
In accordance with ADR / RID / IMDG / IATA / ADN
ADR | IMDG | IATA | ADN | RID |
14.1. UN number | ||||
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
14.2. UN proper shipping name | ||||
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
14.3. Transport hazard class(es) | ||||
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
14.4. Packing group | ||||
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
14.5. Environmental hazards | ||||
Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
No supplementary information available | ||||
14.6. Special precautions for user
- Overland transport |
Not applicable |
- Transport by sea |
Not applicable |
- Air transport |
Not applicable |
- Inland waterway transport |
Not applicable |
- Rail transport |
Not applicable |
14.7. Transport in bulk according to Xxxxx XX of MARPOL and the IBC Code
Not applicable
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.1.1. EU-Regulations
Contains no REACH substances with Annex XVII restrictions Contains no substance on the REACH candidate list Contains no REACH Annex XIV substances
15.1.2. National regulations
Germany | ||
VwVwS Annex reference | : | Water hazard class (WGK) nwg, Non-hazardous to water (Classification according to VwVwS, Annex 4) |
12th Ordinance Implementing the Federal Immission Control Act - 12.BImSchV | : | Is not subject of the 12. BlmSchV (Hazardous Incident Ordinance) |
Netherlands | ||
SZW-lijst van kankerverwekkende stoffen | : | None of the components are listed |
SZW-lijst van mutagene stoffen | : | None of the components are listed |
NIET-limitatieve lijst van voor de voortplanting giftige stoffen – Borstvoeding | : | None of the components are listed |
NIET-limitatieve lijst van voor de voortplanting giftige stoffen – Vruchtbaarheid | : | None of the components are listed |
NIET-limitatieve lijst van voor de voortplanting giftige stoffen – Ontwikkeling | : | None of the components are listed |
Denmark | ||
Recommendations Danish Regulation | : | Pregnant/breastfeeding women working with the product must not be in direct contact with the product |
15.2. Chemical safety assessment
No chemical safety assessment has been carried out
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 |
IMDG | International Maritime Dangerous Goods |
IATA | International Air Transport Association |
EC50 | Median effective concentration |
DNEL | Derived-No Effect Level |
DMEL | Derived Minimal Effect level |
ATE | Acute Toxicity Estimate |
CLP | Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008 |
BCF | Bioconcentration factor |
LC50 | Median lethal concentration |
LD50 | Median lethal dose |
PBT | Persistent Bioaccumulative Toxic |
PNEC | Predicted No-Effect Concentration |
REACH | Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) No 1907/2006 |
RID | Regulations concerning the International Carriage of Dangerous Goods by Rai |
SDS | Safety Data Sheet |
vPvB | Very Persistent and Very Bioaccumulative |
SECTION 16: Other information Abbreviations and acronyms:
Data sources | : | REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. |
Full text of H- and EUH-statements:
Acute Tox. 3 (Dermal) | Acute toxicity (dermal), Category 3 |
Acute Tox. 3 (Oral) | Acute toxicity (oral), Category 3 |
Acute Tox. 4 (Oral) | Acute toxicity (oral), Category 4 |
Aquatic Acute 1 | Hazardous to the aquatic environment — Acute Hazard, Category 1 |
Eye Dam. 1 | Serious eye damage/eye irritation, Category 1 |
Skin Corr. 1B | Skin corrosion/irritation, Category 1B |
Skin Irrit. 2 | Skin corrosion/irritation, Category 2 |
Skin Sens. 1 | Sensitisation — Skin, Category 1 |
STOT RE 2 | Specific target organ toxicity — Repeated exposure, Category 2 |
STOT SE 3 | Specific target organ toxicity — Single exposure, Category 3, Respiratory tract irritation |
H301 | Toxic if swallowed |
H302 | Harmful if swallowed |
H311 | Toxic in contact with skin |
H314 | Causes severe skin burns and eye damage |
H315 | Causes skin irritation |
H317 | May cause an allergic skin reaction |
H318 | Causes serious eye damage |
H335 | May cause respiratory irritation |
H373 | May cause damage to organs through prolonged or repeated exposure |
H400 | Very toxic to aquatic life |
SDS EU (REACH Annex II)
This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product