ZHIVAS LTD
SAFETY DATA SHEET
In accordance with the requirements of the Regulation on the procedure and terms of classification, packaging and labeling of
existing and new chemical substances, preparations and products, Appendix No. 16 to Art. 41, Para 1 (SG, issue 5/2002)
Date of issue: August 31st, 2006
Issue: 01/2006
Supercedes issue: new
1. Identification of the substance/preparation and of the company/undertaking
1.1. Trade name of the preparation: “POVISEPT”
1.2. Usage of the preparation: preparation for disinfection of skin and operating field
1.3. Name and address of the individual, placing the preparation on the market:
“ZHIVAS” LTD, 36 “Dondukov” Blvd., Sofia
1.4. Contact telephone number in case of emergency: telephone No: (+ 359 2) 981 78 23
Telephone No of the Multi-profile Hospital of Active Treatment and Emergency Medicine “N.I.Pirogov”: 915-44-11
2. Composition / information on ingredients
2.1. General properties of the chemical substances and their percentage content.
Active ingredient: POLYVINYLPYROLYDON-IODINE 10 %.
Other ingredients: citric acid 1.023 %, disodium hydrogen phosphate 1.328 % and deionized water up to 100 %.
2.2. Concentrations or limit values of substances’ concentrations – for preparations, classified as dangerous:
CAS No/ ЕС No
Rel. %
Citric acid
77-92-9
1.023%
Disodium hydrogen phosphate,
anhydrous
7558-79-4
1.328%
Chemical designation
Hazard symbol,
R-phrases, S-phrases
Xi, R 36/37/38,
S 26, 37/38.
Permitted by Regulation No8/ SG, issue 44/2002
Xi, R 36/37/38
S 26, 37/38.
2.3. Concentrations or limit values of substances’ concentrations – for preparations, which are not classified
as dangerous:
2.4. Classification of substances under the preceding item:
Designations and numbers of the substances under EINECS or ELINCS.
Substance
EINECS or ELINCS.
Disodium hydrogen phosphate
231-448-7
Citric acid
201-069-1
3. Hazards identification
Main routes of exposure: by skin, oral
No harmful effects are expected in case of entry into the organism and in contact with skin and mucous membranes.
4. First aid measures
Page 1 of 5
4.1. After inhalation: not applicable.
4.2. After skin contact: Immediately take off the contaminated working clothes. Wash the contaminated skin areas
thoroughly with water until the colouring would disappear. Wash the working clothes before using them again.
4.3. After eye contact: Rinse immediately with plenty of running water with eyelids wide open for 15 - 20 minutes.
Consult a physician – ophthalmologist in case the irritation persists.
4.4. After swallowing: Rinse the mouth with water. If the person is unconscious he must not be given liquids
through the mouth. Seek medical advice immediately.
4.5. Necessity of qualified medical help (compulsory or recommendable): in case of eye contact and in case of
swallowing and presence of symptoms or irritation seek medical advice. In case of swallowing – the treatment is
symptomatic.
4.6. Special means for first aid at the work place: none.
5. Fire-fighting measures
5.1. Suitable extinguishing media: Not highly inflammable. In case of burning together with other flammable
materials - СО2, fire extinguishing powder.
5.2. Media unsuitable for fire extinguishing for security reasons: full water stream. It may be used for cooling
of containers.
5.3. Specific hazards, related to exposure to the preparation and resulting products of burning and gasses
liberated: in case of fire toxic gases may be formed: nitrogen oxides, iodine, hydrogen iodide. In case of burning
of the PE package may be formed: СО, СО2, ethylene, methane, ethane, propane, propylene, cycloaliphatic
hydrocarbons, formaldehyde, acetaldehyde, butylenes, butane.
5.4. Special protection equipment for fire-fighters: suitable work clothes, self-contained breathing apparatus
with full protection of the face.
6. Accidental release measures
6.1. Personal precautions: work clothes, latex gloves, protective goggles, providing of adequate overall or local
ventilation. Avoid contact with the eyes. Remove sources of ignition.
6.2. Environmental protection measures:
Localize and stop the leakage. Take measures to not allow the pollution of surface and underground waters, soil as
well as release to the sewerage system. In case of pollution inform the local authorities.
6.3. Means of cleaning and take-up: use suitable adsorbing materials (sand, shavings, soil).
The treatment by using sodium tiosulphite or sodium hydrogen sulphite lead to rendering the iodine harmless.
7. Handling and storage
7.1. Handling: Avoid direct contact with eyes and skin.
7.2. Storage: in original, well closed package, in dry and well ventilated premises, away from foodstuffs, drinks and
under temperatures of 5о -40оС. Do not expose it to direct sunlight. Do not store it together with strong oxidizers and
acids.
7.3. Specific use: for professional use only
8. Exposure controls / personal protection
8.1. Limits of exposure:
The preparation is water-based solution and there shall not be expected any release of iodine vapours in the air
under normal conditions of use.
In case of accidental situations and fire the limit values for the air in the work environment are specified, as
follows:
Page 2 of 5
Ingredients
Iodine
CAS No/
EINECS
7553-56-2
Limit values for the air in the work environment
3 mg/m3
Regulation No 13/ 2003
8.2. Control of exposure
8.2.1. Control in case of exposure under work environment: providing of general and local ventilation.
8.2.1.1. Respiratory protection: not applicable.
8.2.1.2. Hand protection: gloves, resistant to solvents.
8.2.1.3. Eye protection: tightly fixed protective goggles.
8.2.1.4. Skin and body protection: work clothing.
8.2.2. Control of the preparation’s impact over the environment: do not allow spilling in the sewerage system.
Avoid the pollution of soil, air, water sources and sewerage system.
9. Physical and chemical properties
9.1. General information
- Appearance – liquid
- Colour – reddish-brown
- Odor – specific
9.2. Some important information, related to the human health, safety and the environment
INDICATORS
VALUES
State of aggregation
Liquid
Colour
Reddish-brown
Odor
Specific
Explosion properties
Not explosive
Oxidation properties
Not an oxidizer
Inflammation temperature, limits
Not applicable
Fire point
Not applicable
Self-inflammation temperature
Not applicable
Boiling point
No data available
pH of the undiluted solution
3.5 – 5.5, 200 С
Relative density
1.035 g/cm3, 20оС
Stability when stored
The preparation is stable when stored under normal
conditions, with temperature of 5-40оС
Effect of light, temperature and humidity over the technical
Do not expose it to direct sunlight, not to exceed
characteristics of the preparation
the temperature of 50оС
Reactivity in relation to the material of the package
The formulation is in conformity with PENN
Foaming, possibility of wetting, dust formation
No data. The preparation is a liquid. It is not
foamy.
Physical and chemical compatibility with other biocidal
It is not used and applied together with other
preparations, which it is used and applied together with
biocidal preparations.
9.3. Other information – none
10. Stability and reactivity
10.1. Conditions to avoid: high temperatures exceeding 50оС, sources of heat and direct sunlight.
10.2. Substances to avoid: strong oxidizers and acids.
10.3. Hazardous products of decomposition: not expected upon compliance with the operating instructions.
Page 3 of 5
11. Toxicological information
The parameters of strong toxicity
- LD 50 oral, rat (evaluated) – > 2000 mg/kg body weight.
- LD50 dermal, rat (evaluated) – > 2000 mg/kg body weight.
- Lack of skin and eye irritating effect.
- Lack of skin sensitization.
12. Ecological information
12.1. Eco-toxicity. The biocidal preparation “Povisept”, under the conventional method, is not classified as
“Dangerous for the environment” and does not require any Risk (R-) phrases.
Strong toxicity to fish:
Data about elemental iodine
LC50, 96 hours, Oncorhynchus mykiss - 1.67 mg/l;
LC50, 96 hours, Poecilia reticulata – 3.0 mg/l;
Strong toxicity to Daphnia magna.
Data about elemental iodine:
EC50, 48 hours, Daphnia magna - 0.16 – 0.59 mg/l.
Inhibiting effect on the growth of algae: no data available
Inhibiting effect on microbiological activity: No data available.
12.2. Mobility – the preparation is soluble in water. In case of falling into soil it is expected to reach to the subsoil
waters, and if spilled on soil – to penetrate deeply.
12.3. Stability and degradability – the polymer, representing 10 % of the preparation is hardly biodegradable.
12.4. Potential for bioaccumulation – bioaccumulation is not expected.
12.5. Other undesired effects – no data available.
13. Disposal considerations
Classification of the wastes from the biocidal preparation and packages in accordance with the Regulation on the
classification of wastes (RCW) /SG, issue 44/2004/.
- In case of usage of the biocidal preparation for disinfection of operating field, the wastes from it are
classified with the code and designation, as follows: 18 01 07 – chemical substances and preparations,
different form 18.01.06. of the human healthcare;
- Package, code and designation of the waste: 15.01.02 – plastic packages
The rinsing waters are not treated as dangerous waste on account of the fact that they do not meet the requirements
of the Regulation on the classification of wastes (Regulation No. 3 of 2004), Art. 6, Para 2, it. 3.
Disposal of wastes – washing and recycling upon compliance with the requirements of the local legislation.
In case that on the territory of the built-up area there exist an organized system for separated collection and/or
disposal of wastes for recycling, and the package of the biocidal preparation is designated with marking for
separated collection, then the wastes from the biocidal preparation and the packages shall have to be disposed of
and/or delivered to the places specified for this purpose.
Avoid the pollution of the surface, subsoil waters and sewerage system.
Page 4 of 5
14. Transport information
It does not pose any hazard in case of transport. Transport it in covered vehicles, separately from foodstuffs and
drinks.
15. Regulatory information
In accordance with the requirements of the Regulation on the terms and procedure for classification, packaging and labeling of
chemical substances and preparations (adopted by a Decree of the Council of Ministers No 316 of Dec 20th, 2002, promulg.,
SG, issue 5 of Jan 17th, 2003, as amended in issue 66 of July 30th, 2004, further amended in issue 50 of 2005 and issue 57 of
2005) the preparation is not classified into the categories of hazard and does not require any risk (R-) phrases.
Safety advices /S-phrases/:
S 2 Keep out of the reach of children.
S 25 Avoid contact with eyes.
S 45 In case of accident or if you feel unwell seek medical advice immediately (show the label where possible).
S 61 Avoid release to the environment. Refer to special instructions / safety data sheet.
16. Other information
The information in the Safety Data Sheet is based on the current level of knowledge by the date of its preparing.
Since making use of the information and the conditions of use are beyond the company’s control, the user of the
trade product shall bear responsibility for the conditions of its safe application.
Page 5 of 5