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Artificial Tear Fluid · Synelys Biotech

Artificial Tear Fluid

ISO 18369-3:2017

Artificial tear fluid at pH 7.4 with active lysozyme, for contact lens and ophthalmic device testing: protein deposition, cleaning efficacy and material compatibility, on the ISO 18369-3 model.

€1100

Larger volume, a custom pH, or a public tender? Request a quote.

Download SDS (PDF) Look up a batch

Solution Specifications

StandardISO 18369-3:2017
pH7.4
Proteinslysozyme / mucin / albumin
Sterilisationautoclave (saline) · 0.22 µm (protein version)
Storageprotein version 2–8 °C · saline version 15–25 °C
Shelf lifemade to order, use-by date on the label · lysozyme has to still be active when it reaches you
ContainerHDPE bottle (PP cap)
HS code3822.90.00

Composition & Formulation

  • Salts: NaCl, KCl, CaCl₂, NaHCO₃
  • Lacrimal proteins: lysozyme, albumin, mucin
  • ± lipid variants
  • pH ~7.4, physiological osmolarity

Available Formats & Packaging

  • 100 mL
  • 200 mL
  • 500 mL
  • 1 L

Main Function & Applications

Incubate lenses or devices to study protein deposits, active-ingredient release, or care-solution performance. Made fresh with active proteins and shipped cold, so it behaves like real tears on your bench.

ISO 18369-3:2017 test protocol

User Sectors & Laboratories

  • Contact-lens makers
  • Lens-care solution makers
  • Intraocular implants (IOL)
  • Ophthalmic pharma & device CROs

Good to know

The protein version is made to order and ships on a cold chain, so the lysozyme reaches you active. The saline version is room-temperature stable and needs no cold chain.

Certificate of Analysis (CoA) & Traceability

  • pH 7.4
  • Osmolarity
  • Lysozyme activity
  • Sterility, by the route that suits the version
  • Manufacturing & best-before date

Common questions about this product

What is Artificial Tear Fluid made of?

Synelys Biotech Artificial Tear Fluid is an aqueous solution of Salts: NaCl, KCl, CaCl₂, NaHCO₃; Lacrimal proteins: lysozyme, albumin, mucin; ± lipid variants. It is the reference solution defined by ISO 18369-3:2017, made fresh to order in Toulouse, France and shipped with a Certificate of Analysis on every batch.

What pH is it supplied at, and can it be adjusted?

Artificial Tear Fluid is supplied at pH 7.4. pH is verified batch by batch and the measured value appears on the Certificate of Analysis.

How is ISO 18369-3:2017 testing actually run?

The full protocol, preparation, immersion ratio, duration, temperature and analytical method, is set out in our ISO 18369-3:2017 guide, written for laboratory analysts. Read the protocol

Not sure it matches your protocol? Ask for a free 30 mL sample with its Certificate of Analysis, and test it against your own method first.

Understand the method

Ophthalmic Guide #6Contact Lenses: Which Part of ISO 18369 Applies (ISO 18369)Selection Guide #13How Long Does a Simulated Test Fluid Last? The Four Clocks
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ISO 10271

Specimen Certificate of Analysis (CoA)

SYNELYS BIOTECH
Quality Control Laboratory, Toulouse, France

CERTIFICATE OF ANALYSIS

Specimen · issued with every batch
Product: —
Test Standard: —
Batch Number: SYB-2026-0724-A
Manufacturing Date: 2026-07-24
Expiry Date: 2027-01-24
Analyzed ParameterSpecificationMethodResultStatus
…

The results relate only to the batch identified above. Measurements were made with instruments calibrated against certified reference solutions (pH buffers, KCl conductivity standard, class E2 masses) and are recorded in the batch record, which states raw-material lots and the production and control history. Synelys Biotech is not an ISO/IEC 17025 accredited laboratory and makes no claim of metrological traceability to a national standard. This is a specimen: figures are representative of a released batch and are not those of any particular lot.

Quality Visa & Batch Release:Quality manager
Released by, quality control · 2026-07-24
CoA template v2 · 2026-09-04—Page 1 of 1

Request a Free Sample (30 mL)

Test our standard-grade fluids directly on your test bench. Shipped free of charge by tracked post with specimen CoA.

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Safety Data Sheet (SDS)

Synelys Biotech SAS Quality Control Laboratory · Toulouse, France Regulation (EC) No 1907/2006 (REACH), Annex II, as amended by Regulation (EU) 2020/878

SAFETY DATA SHEET

Artificial Tear Fluid

Revision 3.0 · 2026-09-06
GHS / CLP CLASSIFICATION: MIXTURE NOT CLASSIFIED AS HAZARDOUS
Not subject to ADR Azide-free (no NaN₃) HS code 3822.90.00
SECTION 1
Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name: Artificial Tear Fluid. Product number: TE1. Mixture; no REACH registration number, the mixture is not a registrable substance.
1.2 Relevant identified uses and uses advised against
Identified use: laboratory test reagent, for conformity and development testing to ISO 18369-3:2017. Professional use in a laboratory only.
Uses advised against: any use in or on humans or animals; any clinical, diagnostic or therapeutic use; use as a cosmetic, a medical device, a food or a feed; supply to the general public.
1.3 Details of the supplier of the safety data sheet
Synelys Biotech SAS
Toulouse, France
hello@synelysbiotech.com
1.4 Emergency telephone number
Company: hello@synelysbiotech.com (office hours).
France, 24/7: ORFILA +33 (0)1 45 42 59 59, index of the national poison centres.
Germany, 24/7: Giftinformationszentrum, regional numbers at bvl.bund.de.
Within the EU: 112.
SECTION 2
Hazards identification
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 (CLP): the mixture is not classified. No physical, health or environmental hazard class is met.
2.2 Label elements
No hazard pictogram, no signal word and no hazard statement are required. Precautionary statements: none required. The label carries the product name, the reference standard, the batch number, the volume, the filling date, the best-before date and the statement that the product is for laboratory testing use only.
2.3 Other hazards
The mixture does not meet the PBT or vPvB criteria of Annex XIII and contains no constituent identified as having endocrine disrupting properties under Regulation (EU) 2018/1881. Spillage makes a floor slippery. A container held below its recommended temperature may freeze and split.
SECTION 3
Composition / information on ingredients
3.2 Mixtures
Aqueous mixture. Chemical characterisation: inorganic salts and organic metabolites in purified water. Composition as formulated, per litre of ready-to-use solution:
Water (CAS 7732-18-5) > 98 %; sodium chloride (CAS 7647-14-5), potassium chloride (CAS 7447-40-7), calcium chloride dihydrate (CAS 10035-04-8) and sodium bicarbonate (CAS 144-55-8), each < 1 %; lysozyme from hen egg white (CAS 12650-88-3), bovine serum albumin (CAS 9048-46-8) and mucin (CAS 84082-64-4), each < 0.5 %.
No constituent is present at or above its generic concentration limit, so the mixture stays unclassified. Water is stated for completeness. No component is an SVHC of the candidate list at or above 0.1 % w/w.
SECTION 4
First aid measures
4.1 Description of first aid measures
General: remove soiled clothing. Show this safety data sheet to the doctor.
After inhalation: not an anticipated route of exposure, the product is a non-volatile aqueous solution. Move to fresh air if an aerosol has been generated.
After skin contact: wash with water and soap. If irritation persists, seek medical advice.
After eye contact: rinse with running water for at least 15 minutes, holding the eyelids apart. Remove contact lenses if present and easy to do. If irritation persists, seek medical advice.
After swallowing: rinse the mouth and drink water. Do not induce vomiting. Seek medical advice if symptoms occur.
4.2 Most important symptoms and effects, both acute and delayed
None expected under the conditions of use. A prolonged skin contact with an acidic formulation may cause transient reddening. No delayed effect is known.
4.3 Indication of any immediate medical attention and special treatment needed
Symptomatic treatment. No specific antidote is known or required.
SECTION 5
Firefighting measures
5.1 Extinguishing media
Suitable: water spray, carbon dioxide, dry powder, alcohol resistant foam. The product itself is not combustible and does not sustain a fire.
Unsuitable: none. Choose the media appropriate to the surrounding fire.
5.2 Special hazards arising from the substance or mixture
None specific. In a fire, evaporation of the water fraction may concentrate the dissolved salts and organic constituents in the residue. Thermal decomposition of the organic fraction can release carbon oxides and, where nitrogen bearing constituents are present, nitrogen oxides and ammonia.
5.3 Advice for firefighters
As in any fire, wear self-contained breathing apparatus and full protective clothing. Do not allow firefighting water to enter drains or watercourses.
SECTION 6
Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Wear the protective equipment of section 8. Beware of a slippery floor. No evacuation or special respiratory protection is required for a laboratory scale spill.
6.2 Environmental precautions
Do not discharge a bulk quantity to a drain, to surface water or to the ground. A laboratory quantity may be flushed with plenty of water where local regulations allow it.
6.3 Methods and material for containment and cleaning up
Contain with an inert absorbent (paper, sand, diatomite, universal binder). Collect into a labelled container and dispose of according to section 13. Rinse the area with water and dry it.
6.4 Reference to other sections
Safe handling: section 7. Personal protective equipment: section 8. Disposal: section 13.
SECTION 7
Handling and storage
7.1 Precautions for safe handling
Normal laboratory practice. Avoid contact with the eyes. Do not eat, drink or smoke where the product is handled. Wash the hands after handling. Close the container after use: an opened container is exposed to microbial contamination, and this product carries no preservative.
7.2 Conditions for safe storage, including any incompatibilities
Storage: protein version 2–8 °C · saline version 15–25 °C
Shelf life: made to order, use-by date on the label · lysozyme has to still be active when it reaches you
Container: HDPE bottle (PP cap)
Keep away from direct sunlight and from freezing. Do not store with strong oxidisers or strong acids. Do not return an unused portion to the original container.
7.3 Specific end use(s)
Laboratory test reagent. See section 1.2. No exposure scenario is attached: a chemical safety assessment is not required for this mixture.
SECTION 8
Exposure controls / personal protection
8.1 Control parameters
No constituent is present in a quantity that requires an occupational exposure limit to be monitored at the workplace. No DNEL or PNEC is available for the mixture; none is required, no chemical safety assessment being called for.
8.2 Exposure controls
Engineering controls: general laboratory ventilation. A fume hood is not required. An eye wash station must be accessible.
Eye and face protection: safety glasses to EN 166.
Skin protection: nitrile gloves to EN ISO 374-1, minimum thickness 0.11 mm. Breakthrough time is not determined for this mixture and must be confirmed by the glove manufacturer. Laboratory coat.
Respiratory protection: not required.
Environmental exposure controls: see sections 6.2 and 13.
SECTION 9
Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: Liquid
Colour: Slightly opalescent, normal with mucin
Odour: Odourless
Melting point / freezing point: Approximately 0 °C, the mixture being predominantly water. Not determined experimentally.
Boiling point or initial boiling point and boiling range: Approximately 100 °C at 1013 hPa. Not determined experimentally.
Flammability: Non-flammable. Aqueous solution with no flammable constituent.
Lower and upper explosion limit: Not applicable.
Flash point: Not applicable.
Auto-ignition temperature: Not applicable.
Decomposition temperature: Not determined.
pH: 7.4
Kinematic viscosity: Not determined. Comparable to water.
Solubility: Fully miscible with water. Not determined in organic solvents.
Partition coefficient n-octanol/water (log value): Not determined. Not meaningful for a mixture of inorganic salts in water.
Vapour pressure: Approximately 23 hPa at 20 °C, that of water. Not determined experimentally.
Density and/or relative density: Approximately 1.00 to 1.02 g/cm³ at 20 °C. Not determined experimentally.
Relative vapour density: Not determined.
Particle characteristics: Not applicable.
9.2 Other information
No physical hazard class is met: the mixture is neither an oxidiser, nor a self-reactive, pyrophoric, self-heating or water-reactive mixture, nor corrosive to metals. No further safety characteristic is relevant.
SECTION 10
Stability and reactivity
10.1 Reactivity
No reactivity hazard under the recommended conditions of use and storage.
10.2 Chemical stability
Stable within the storage conditions of section 7.2 and up to the stated best-before date. Beyond it the fluid may drift outside the specification without any hazard arising.
10.3 Possibility of hazardous reactions
None known.
10.4 Conditions to avoid
Freezing, prolonged heating, direct sunlight, and an open container.
10.5 Incompatible materials
Strong oxidisers. Strong acids and bases. A chloride bearing fluid attacks unprotected carbon steel and some stainless grades: use inert labware.
10.6 Hazardous decomposition products
None under normal conditions. On thermal decomposition, see section 5.2.
SECTION 11
Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
No toxicological study has been performed on the mixture. The assessment below is derived from the constituents by the calculation method of Regulation (EC) No 1272/2008. It is not a statement that the mixture has been tested.
Acute toxicity: Not classified.
Skin corrosion/irritation: Not classified.
Serious eye damage/eye irritation: Not classified.
Respiratory or skin sensitisation: Not classified.
Germ cell mutagenicity: Not classified.
Carcinogenicity: Not classified.
Reproductive toxicity: Not classified.
STOT-single exposure: Not classified.
STOT-repeated exposure: Not classified.
Aspiration hazard: Not classified.
11.2 Information on other hazards
Endocrine disrupting properties: no constituent is identified as an endocrine disruptor under Regulation (EU) 2018/1881.
Other information: the product is not intended for human or animal use. An acidic formulation may transiently redden the skin on prolonged contact.
SECTION 12
Ecological information
12.1 Toxicity
No data available on the mixture. No constituent is classified as hazardous to the aquatic environment.
12.2 Persistence and degradability
The organic fraction (urea, lactic acid, amino acids, glucose) is readily biodegradable. The inorganic salts are not degradable and dissociate in water. No test has been run on the mixture.
12.3 Bioaccumulative potential
Not expected. The constituents are water soluble and of low molecular mass.
12.4 Mobility in soil
High. A water soluble mixture spreads with soil water.
12.5 Results of PBT and vPvB assessment
The mixture does not meet the criteria of Annex XIII. PBT: no. vPvB: no.
12.6 Endocrine disrupting properties
No constituent is identified as an endocrine disruptor.
12.7 Other adverse effects
A large discharge raises the salinity and the nutrient load of a receiving water. Do not discharge in bulk.
SECTION 13
Disposal considerations
13.1 Waste treatment methods
Product: the waste is not classified as hazardous. A laboratory quantity may go to the drain with plenty of water where local rules allow it. A bulk quantity goes to a licensed waste contractor. A batch that has been in contact with a test specimen may carry released metals and is then handled as the specimen requires, not as this sheet describes.
Waste code: assigned by the waste holder according to the origin of the waste, under Commission Decision 2000/532/EC. We do not assign it, not being the holder.
Packaging: rinse the HDPE or PP container with water; it is then recyclable with the plastics stream.
SECTION 14
Transport information
14.1 UN number or ID number
Not applicable.
14.2 UN proper shipping name
Not applicable.
14.3 Transport hazard class(es)
Not applicable.
14.4 Packing group
Not applicable.
14.5 Environmental hazards
No. Not a marine pollutant.
14.6 Special precautions for user
None. Carry upright and secured. Protect from frost in winter transport.
14.7 Maritime transport in bulk according to IMO instruments
Not applicable.
Not classified as dangerous goods under ADR, RID, ADN, IMDG or IATA. No dangerous goods declaration, no limited quantity marking and no dangerous-goods surcharge apply.
SECTION 15
Regulatory information
15.1 Safety, health and environmental regulations specific for the substance or mixture
Regulation (EC) No 1907/2006 (REACH): no constituent is on the Annex XIV authorisation list, and none is restricted under Annex XVII for this use. No constituent appears on the candidate list of substances of very high concern at or above 0.1 % w/w.
Regulation (EC) No 1272/2008 (CLP): mixture not classified.
Directive 2012/18/EU (Seveso III): not covered.
Regulation (EU) 2019/1148 (explosives precursors): no listed substance.
Regulation (EC) No 273/2004 (drug precursors): no listed substance.
National provisions: none specific. The product is not a cosmetic, a medical device, a biocide, a detergent, a food or a feed, and none of those regimes applies to it.
15.2 Chemical safety assessment
No chemical safety assessment has been carried out for this mixture. None is required: the supplier of a mixture is not obliged to carry one out under Title II of Regulation (EC) No 1907/2006.
SECTION 16
Other information
Abbreviations
ADR/RID/ADN/IMDG/IATA: transport of dangerous goods by road, rail, inland waterway, sea and air. CLP: Regulation (EC) No 1272/2008. DNEL: derived no-effect level. PNEC: predicted no-effect concentration. PBT: persistent, bioaccumulative and toxic. vPvB: very persistent and very bioaccumulative. STOT: specific target organ toxicity. SVHC: substance of very high concern. CAS: Chemical Abstracts Service.
Full text of the hazard statements used
None. No hazard statement applies to this mixture.
Revision
Revision 3.0 of 2026-09-06. This revision rewrites the sheet per product: sections 1, 2, 3, 7, 9, 11 and 16 now carry values specific to this reference rather than to the range. Section 9 is completed to the list of Annex II as amended by Regulation (EU) 2020/878, and section 11 states derived classification rather than an untested conclusion. Supersedes all earlier editions.
Notice
The information above rests on the state of our knowledge on the date of issue. It describes the product with regard to safety requirements and is not a warranty of any property. The user remains responsible for observing the law applicable to their own use, and for the risk assessment of the workplace where the product is handled. This product is for laboratory testing use only, not for use in or on humans or animals.
Download this sheet (PDF)

Batch Certificate & SDS Search

Enter the batch number printed on your bottle label (e.g. LOT-2026-0724) to access certified Quality Control records.

Made in France, shipped from Toulouse

Made to order in our own laboratory
No distributor between our laboratory and your bench. Your lead time is on the quote.
Cold chain for protein fluids
Active-lysozyme tears and enzyme fluids travel on cooling packs.

Shipped from inside the EU: no customs, no import duty, no clearance delay, prices in euros.