DIPHOTERINE® - Information

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DIPHOTERINE® SOLUTION – INFORMATION / PRODUCTS / PRODUCT INFORMATION

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DIPHOTERINE® Solution is an aqueous, polyvalent, washing solution that is highly effecting against all kinds of Corrosive and Irritant Chemicals (*).

(*) IMPORTANT: It has limited efficacy on Hydrofluoric Acid – please use HEXAFLUORINE SOLUTION)

DIPHDIPHOTERINE® Solutions is an amphoteric, chelating molecule with at least one site able to rapidly and effectively absorb and neutralise the aggressive chemical molecule to prevent the 6 possible reactions (acids, bases, oxidizers, reducing agents, solvents, chelating agents)

DIPHOTERINE® Solutions is hypertonic which, when applied to the eye or the skin, creates an osmotic pressure that attracts the aggressive chemical that may have already penetrated into the tissue, neutralises its aggressive action and carries it safely away.

It is by the combination of these properties that DIPHOTERINE® Solutions uniquely able to achieve the three elements demanded for effective Emergency First Aid of a chemical splash:

  • Removal of chemical from the surface of the tissue.
  • Absorptionn and neutralisation of the aggressive chemical molecule remaining on the tissue surface.
  • Attraction, absorption and neutralisation of the aggressive chemical molecule already penetrating the tissue.

Tests have shown the DIPHOTERINE® Solutions compared to water

Safe

Non Irritant to: (the eyes) – Graefe’s Arch Exp Opthamol 202.240.308-313 / Safepharm Laboatories Limited UK 133/4

(the skin) – Integra, Italy 2005-024

Non cytotoxic  – Integra, Italy REL/003/06/IRRC/ELB, ISO 10993-5 standard

Non sensitizng – CERB, France 20030418ST

Non toxic by: (Ingestion) – International Centre of Toxicology, France 6564 TAR

Skin – Safepharm Laboratories Limited UK 133/9

iv injection – CERB, France 20030856ST

Experience – 25 years use in industry throughout Europe

 

Medical Device: – Registered as Medical Device, Class lla

European Standards: – Conforms with EN15154: Parts 3 and 4

 

Frequently Asked Questions

1.   What is the DIPHOTERINE® Solution?

DIPHOTERINE® Solution is a polyvalent, hypertonic, amphoteric, chelating agent for the emergency decontamination of eye/skin chemical splashes. It is supplied as a sterile solution in water.   When utilized during the initial minute following the splash and with the total quantity delivered from the application device, external decontamination with the DIPHOTERINE® Solution has the objective of preventing or minimizing the appearance of lesions, and thus the reducing risk of sequelae.

minimizing the appearance of lesions, and thus the reducing risk of sequelae.

2.   What is the mechanism of action of the DIPHOTERINE® Solution?

DIPHOTERINE® Solution has active binding sites and as an amphoteric compound can bind chemically opposite compounds such as acids-bases, oxidizers-reducing agents, etc.   It is a chelating compound.   Its hypertonicity to the body also aids in setting up an osmotic gradient which can stop the penetration of chemicals and assist in removing chemicals which have already penetrated into the tissue.

3.   Why is the DIPHOTERINE® Solution hypertonic?

DIPHOTERINE® Solution is hypertonic in order to stop and avoid the penetration of the chemicals into the tissues.   An hyperosmolar pressure creates a flux from the inside to the outside of the tissues: the chemicals are then pulled out from the inside of the tissues surface, skin or eye.   With a hypertonic solution, the decontamination is, therefore, accelerated.

4.   Why is the DIPHOTERINE® Solution Amphoteric?

An amphoteric compound is one capable of binding (and thus decontaminating) opposing chemical substances such as acids-bases or oxidizers-reducing agents.   Rinsing with an amphoteric solution such as the DIPHOTERINE® Solution allows a quick return to a normal physiological state and has the objective of securing the result of the rinsing.

5.   Is the DIPHOTERINE® Solution a Chelator?

Yes, the DIPHOTERINE® Solution is a chelator. It can chelate radionuclides such as strontium, cobalt, cesium or uranium. It can chelate anions such as oxalate, but doesn’t chelate calcium or magnesium.    What are the demonstrated advantages of the DIPHOTERINE® solution regarding efficacy?  The DIPHOTERINE® Solution is polyvalent, as such, it is effective against a very wide range of chemicals/chemical groups (over 600 tested in vitro), including acids, bases, oxidizers, reducing agents, irritants, solvents, and lacrimators. It is thus a logical choice for use in decontaminating unknown chemical splashes.

6.   What is the toxicity of the DIPHOTERINE® solution?     Does it have toxicity / irritancy / sensitization potential?

  1. DIPHOTERINE® Solution is non-toxic (LD50 > 2,000 mg/kg oral/skin in experimental animals).   No toxicity has been reported in human workplace use despite the fact that the manufacturer has had an active pharmacovigilance program.

b.   No mutagenic effect was detected by Ames test.

  1. DIPHOTERINE® Solution itself and its reaction residues with strong acid and base are not irritating in rabbit eyes. It was not irritating to the eyes of normal human volunteers.   No adverse effects have been reported following its use in industrial accidents.   In trials DIPHOTERINE® solution was not shown to be a skin sensitizer.

d.   In ecotoxicity tests, it was non-toxic to standard test organisms.

7.   For which uses is the DIPHOTERINE® Solution recommended?

The DIPHOTERINE® solution is recommended for skin/eye decontamination of nearly all chemical substances, such as acids, bases, oxidizers, reducing agents, and solvents.

8.   What are the limitations of the DIPHOTERINE® Solution?    


  a.   Is the DIPHOTERINE® Solution active against all chemical products?

  1. DIPHOTERINE® Solution has limited efficacy on hydrofluoric acid (HF) exposures or fluorides in an acidic mix.

A derivative product, the HEXAFLUORINE® Solution, is available and efficacious for HF exposures.

DIPHOTERINE® Solution is not suitable for white phosphorous decontamination.

b.   Is its efficacy in the first few minutes the same after a long delay?

b)  Rinsing with DIPHOTERINE® Solution is most efficacious when used as soon as possible after     the skin/eye chemical exposure (within the first minute).  The longer the delay to use the DIPHOTERINE® Solution, the less likely it is to prevent or decrease the severity of the burn.   Delayed use of the DIPHOTERINE® Solution can stop the action of the chemical product and specific treatment will be necessary to improve wound healing.
Once the exposed skin/eye tissue cells have been destroyed by the splashed chemical, the DIPHOTERINE® Solution can no longer be effective

9.   Is DIPHOTERINE® Solution useful for thermal burns? 

DIPHOTERINE® Solution is not currently recommended for first aid response to purely thermal burns. There are proposals to test it for this use.   Combined thermal/chemical burns from chemicals used at high temperatures may well benefit from initial DIPHOTERINE® Solution decontamination.

It is recommended to first decontaminate the chemical Injury and then to treat the thermal burn.

10.   Can you use the DIPHOTERINE® Solution to decontaminate dusts and chemically inert particulates, including metals?

Because it is a chelator, DIPHOTERINE® Solution can be used to decontaminate metals (as well as radionuclides such as uranium-238, cesium-137, strontium/yttrium-90, and cobalt-60). For dusts and other chemically inert substances, DIPHOTERINE® Solution is supplied as a sterile water-based solution and thus has both dilution and mechanical rinsing activity.   AFTERWASHII®, a comfort isotonic rinsing solution and is more appropriate for dusts and other chemically inert substances.

11.   Can you use the DIPHOTERINE® Solution to decontaminate chemically active solids (i.e., sodium hydroxide, potassium hydroxide, etc.)?

The DIPHOTERINE® Solution can be used to efficiently rinse solid active chemicals. Case reports have been described for pellets of sodium hydroxide following an eye exposure.
DIPHOTERINE® solution rinsing allows dilution of the pellets and, at the same time, to neutralize them, avoiding or stopping the chemical burn, depending on the contact time.
The use of the DIPHOTERINE® Solution is not appropriate for white phosphorous exposures.

12.   What happens if the DIPHOTERINE® Solution is used when there hasn’t been a chemical  exposure?

Nothing. The DIPHOTERINE® Solution is non-toxic and not irritating. It is not a sensitizer.

13.   Can the DIPHOTERINE® Solution be used for Caustic ingestion?

DIPHOTERINE® solution is being studied for decontamination of caustic ingestion in a pig model.   Preliminary data indicate that it can be efficacious in this setting.  It is not currently recommended for this purpose in humans.  DIPHOTERINE® solution is non-toxic as the oral LD50 is greater than 2000 mg/Kg.

14.   Can you decontaminate with water or normal saline before or after the DIPHOTERINE® Solution?   How do you use the DIPHOTERINE® Solution?

In INRS studies, it was found that using water or normal saline either before or after the DIPHOTERINE® solution resulted in a worse outcome than if the DIPHOTERINE® solution was used alone.   Theoretically, this is because using water or saline first delays the use of the active decontamination compound and using water or saline after the DIPHOTERINE® solution washes the active decontamination compound off the skin or out of the eye.

15.   How do you utilize the DIPHOTERINE® Solution for optimal effectiveness?   Is it necessary to use the entire container?

DIPHOTERINE® Solution is optimally utilized as soon as possible after the skin/eye chemical exposure and in sufficient volume.   Workers/rescuers must be trained to use the entire volume of the appropriate size container.   Because the DIPHOTERINE® Solution very rapidly relieves pain once decontamination is started, the use of the total appropriate volume must be an important and frequently emphasized subject of worker/rescuer training.

16.   When should the DIPHOTERINE® Solution be used?

DIPHOTERINE® solution should be used as soon as possible after nearly all skin/eye chemical splashes, with the exception of Hydrofluoric acid (HF) splashes when the HEXAFLUORINE® Solution should be used instead.

Because it is active against a very wide variety of chemical substances, DIPHOTERINE® Solution is particularly well-suited for use with unknown chemical exposures.

17.   Is the DIPHOTERINE® Solution a medication?

No. The DIPHOTERINE® solution has no physiological action on the eye or the skin.
It is registered as a Medical Device in Europe.

18.   Why is there a shelf-life of two years?

The 2-year shelf-life is to ensure :

– that the product is replaced before it loses its sterility
– that the washing solution conserves all of its properties
– that the dispenser remains functional and retains optimal reliability for the end users

19.   Is the eyebath used in the PREVOR eyewash products a Morgan lens?

REVOR put its system of patented eye washes on the market in order to fulfil various requirements, in particular those related to the principle of emergency washing in the workplace:

To allow any casualty to begin washing alone.

To allow the casualty to correctly open the eye in order to make an effective washing.

To allow continuous and uniformly distributed washing of the cornea surface.

The possibility of using the Morgan lens had been considered but dismissed, following various tests showing:

The difficulty of installing the lens in emergency situations, where the intervention time is limited and washing is insufficiently uniform to be effective and a reproducible in all cases.

It is for these reasons that PREVOR conceived, developed and patented its own system of a specific eyebath.

20.   Could a Morgan lens be installed on a PREVOR Eyewash ?

The Morgan lens device is, in particular, designed to deliver the washing solution in the absence of medical personnel. This device could thus have an advantage in the case of a patient with multiple injuries or for the medical management of a large number of patients.
However, the ophthalmologists consulted do not recommend the use of the Morgan lens to carry out ocular washing following a chemical splash because the result is not likely to be sufficiently homogeneous. It has indeed already been noted that when the Morgan lens is used, the washing fluid follows the channels and that created zones which were not irrigated by the instilled solution. However, to be effective in the washing of a chemical projection, it is necessary to irrigate the totality of the cornea and the conjunctival cul-de-sacs. We thus believe that the Morgan lens cannot guarantee the same advantages as manual washing carried out carefully by a specialist.

Note:
Description of the Morgan lens:
Tube connected to a perforated lens.
Diameter of the tube < 2 mm
Polystyrene lens glued to a tube.

Ophthalmologists consulted:
Dr Norbert Schrage, Clinique Ophtalmologique de Merheim
Dr Harold Merle, Centre Hospitalier de Fort de France

21.   Should anaesthetic drops be administered before using the DIPHOTERINE® Solution?

DIPHOTERINE® Solution, which acts directly on the chemical, permits a quick reduction in the sensation of pain. The anaesthetic is thus, in practice, often of no use.   Its possible use in the protocol of certain companies or in a hospital environment under medical ophthalmologic supervision could have only a complementary synergistic effect.

22.   What can you do with the DIPHOTERINE® solution after use ? [How can you dispose of the used DIPHOTERINE® Solution?]

The DIPHOTERINE® Solution neutralizes the splashed chemical actively.   It and its strong caustic decontamination residues are non-toxic and not ecotoxic.   Used DIPHOTERINE® Solution can be disposed of in the sanitary sewer system (unlike water decontamination solutions which will still have active chemical(s) present and should be disposed of as hazardous waste).

23.   What is the purpose of HEXAFLUORINE® Solution?

The HEXAFLUORINE® Solution is a derivative of the DIPHOTERINE® Solution specifically designed to rinse hydrofluoric acid eye/skin splashes and bind and neutralize both the H+ corrosive ions and F toxic ions of hydrofluoric acid (HF).
HEXAFLUORINE® solution can also decontaminate eye/skin splashes due to fluorides in an acidic     environment.

24.   What is the purpose of AFTERWASH II®  solution supplied with DIPHOTERINE® Solution in the wall-mounted eye decontamination station?

The AFTERWASH II® Solution assists in restoring the normal physiological state of the cornea after  DIPHOTERINE® Solution decontamination.    It is also designed for rinsing of chemically inert dusts/particles from the eye.