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MSDS ADMR03 - Lysonox AP (A) - EN202110 Rev.01
MSDS ADMR03 - Lysonox AP (A) - EN202110 Rev.01
1
ADRANOX SRL
Dated 07/10/2021
First compilation
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1.2. Relevant identified uses of the substance or mixture and uses advised against
Intended use Disinfectant for medical devices (e.g. endoscopes)
The product is classified as hazardous pursuant to the provisions set forth in (EC) Regulation 1272/2008 (CLP) (and subsequent amendments and
supplements). The product thus requires a safety datasheet that complies with the provisions of (EU) Regulation 2020/878.
Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet.
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Hazard labelling pursuant to EC Regulation 1272/2008 (CLP) and subsequent amendments and supplements.
Hazard pictograms:
Hazard statements:
Precautionary statements:
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233 Keep container tightly closed.
P280 Wear protective gloves / protective clothing / eye protection / face protection.
P301+P310 IF SWALLOWED: Immediately call a POISON CENTER / doctor / . . .
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing.
Contains: TRIETHYLAMINE
PROPAN-2-OL
N-acetilcaprolattame
On the basis of available data, the product does not contain any PBT or vPvB in percentage ≥ than 0,1%.
The product does not contain substances with endocrine disrupting properties in concentration >= 0.1%.
3.2. Mixtures
Contains:
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The full wording of hazard (H) phrases is given in section 16 of the sheet.
EYES: Remove contact lenses, if present. Wash immediately with plenty of water for at least 30-60 minutes, opening the eyelids fully. Get medical
advice/attention.
SKIN: Remove contaminated clothing. Rinse skin with a shower immediately. Get medical advice/attention.
INGESTION: Have the subject drink as much water as possible. Get medical advice/attention. Do not induce vomiting unless explicitly authorised by a
doctor.
INHALATION: Get medical advice/attention immediately. Remove victim to fresh air, away from the accident scene. If the subject stops breathing,
administer artificial respiration. Take suitable precautions for rescue workers.
4.2. Most important symptoms and effects, both acute and delayed
Specific information on symptoms and effects caused by the product are unknown.
4.3. Indication of any immediate medical attention and special treatment needed
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GENERAL INFORMATION
Use jets of water to cool the containers to prevent product decomposition and the development of substances potentially hazardous for health. Always
wear full fire prevention gear. Collect extinguishing water to prevent it from draining into the sewer system. Dispose of contaminated water used for
extinction and the remains of the fire according to applicable regulations.
SPECIAL PROTECTIVE EQUIPMENT FOR FIRE-FIGHTERS
Normal fire fighting clothing i.e. fire kit (BS EN 469), gloves (BS EN 659) and boots (HO specification A29 and A30) in combination with self-contained
open circuit positive pressure compressed air breathing apparatus (BS EN 137).
Send away individuals who are not suitably equipped. Use explosion-proof equipment. Eliminate all sources of ignition (cigarettes, flames, sparks, etc.)
from the leakage site.
The product must not penetrate into the sewer system or come into contact with surface water or ground water.
Collect the leaked product into a suitable container. Evaluate the compatibility of the container to be used, by checking section 10. Absorb the remainder
with inert absorbent material.
Make sure the leakage site is well aired. Contaminated material should be disposed of in compliance with the provisions set forth in point 13.
Any information on personal protection and disposal is given in sections 8 and 13.
Apply the legislation on Occupational Safety and Hygiene. Use the personal protective equipment described in paragraph 8. Avoid contact with eyes and
skin. Do not inhale vapors or mists. Normal fire prevention measures.
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Follow the product instructions specified on the label or in the information sheet. Also refer to the information on safe use when attached to this safety
data sheet. The solution is exclusively dedicated as an activator for the extemporaneous production of a high-level disinfectant or cold chemical sterilant
of medical surgical devices.
Regulatory References:
DEU Deutschland Technischen Regeln für Gefahrstoffe (TRGS 900) - Liste der Arbeitsplatzgrenzwerte und Kurzzeitwerte.
MAK- und BAT-Werte-Liste 2020, Ständige Senatskommission zur Prüfung gesundheitsschädlicher
Arbeitsstoffe, Mitteilung 56
ESP España Límites de exposición profesional para agentes químicos en España 2021
FRA France Valeurs limites d'exposition professionnelle aux agents chimiques en France. ED 984 - INRS
ITA Italia Decreto Legislativo 9 Aprile 2008, n.81
GBR United Kingdom EH40/2005 Workplace exposure limits (Fourth Edition 2020)
EU OEL EU Directive (EU) 2019/1831; Directive (EU) 2019/130; Directive (EU) 2019/983; Directive (EU) 2017/2398;
Directive (EU) 2017/164; Directive 2009/161/EU; Directive 2006/15/EC; Directive 2004/37/EC; Directive
2000/39/EC; Directive 98/24/EC; Directive 91/322/EEC.
TLV-ACGIH ACGIH 2020
PROPAN-2-OL
Threshold Limit Value
Type Country TWA/8h STEL/15min Remarks /
Observations
mg/m3 ppm mg/m3 ppm
Normal value for the food chain (secondary poisoning) 160 mg/kg
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N-acetilcaprolattame
Predicted no-effect concentration - PNEC
TRIETHYLAMINE
Threshold Limit Value
Type Country TWA/8h STEL/15min Remarks /
Observations
mg/m3 ppm mg/m3 ppm
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Legend:
(C) = CEILING ; INHAL = Inhalable Fraction ; RESP = Respirable Fraction ; THORA = Thoracic Fraction.
VND = hazard identified but no DNEL/PNEC available ; NEA = no exposure expected ; NPI = no hazard identified.
As the use of adequate technical equipment must always take priority over personal protective equipment, make sure that the workplace is well aired
through effective local aspiration.
When choosing personal protective equipment, ask your chemical substance supplier for advice.
Personal protective equipment must be CE marked, showing that it complies with applicable standards.
HAND PROTECTION
In the case of prolonged contact with the product, protect the hands with penetration-resistant work gloves (see standard EN 374).
Work glove material must be chosen according to the use process and the products that may form. Latex gloves may cause sensitivity reactions.
SKIN PROTECTION
None required.
Consider the appropriateness of providing antistatic clothing in the case of working environments in which there is a risk of explosion.
EYE PROTECTION
None required.
In the presence of risks of exposure to splashes or squirts during work, adequate mouth, nose and eye protection should be used to prevent accidental
absorption.
RESPIRATORY PROTECTION
None required, unless indicated otherwise in the chemical risk assessment.
Appearance liquid
Colour colourless
Odour amino
Melting point / freezing point Not available
Initial boiling point 134 °C
Flammability Not available
Lower explosive limit Not available
Upper explosive limit Not available
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Flash point 21 °C
Auto-ignition temperature Not available
Decomposition temperature Not available
pH Not available
Kinematic viscosity 30 mPa*s
Solubility soluble in water Remark:50 g/l
Temperature: 20 °C
Partition coefficient: n-octanol/water Not available
Vapour pressure Not available
Density and/or relative density 1,09
Relative vapour density Not available
Particle characteristics Not applicable
10.1. Reactivity
There are no particular risks of reaction with other substances in normal conditions of use.
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Delayed and immediate effects as well as chronic effects from short and long-term exposure
Information not available
Interactive effects
Information not available
ACUTE TOXICITY
PROPAN-2-OL
LD50 (Oral): 4720 mg/kg Rat
LD50 (Dermal): 16,4 mg/kg Rabbit
LC50 (Inhalation vapours): > 1000 mg/l/4h Rat
N-acetilcaprolattame
LD50 (Oral): 1836 mg/kg Rat
TRIETHYLAMINE
LD50 (Oral): 730 mg/kg Rat
LD50 (Dermal): 580 mg/kg Rabbit
LC50 (Inhalation vapours): 7,1 mg/l/4h Rat
STA (Inhalation vapours): 11 mg/l estimate from table 3.1.2 of Annex I of the CLP
(figure used for calculation of the acute toxicity estimate of the mixture)
CARCINOGENICITY
Does not meet the classification criteria for this hazard class
PROPAN-2-OL
Parameter: NOAEC (carcinogenicity)
Route of exposure: Rat
Effective dose: 5000 ppm
REPRODUCTIVE TOXICITY
Does not meet the classification criteria for this hazard class
PROPAN-2-OL
Parameter: NOAEL (C)
Route of exposure: Rabbit
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Dated 07/10/2021
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ASPIRATION HAZARD
Does not meet the classification criteria for this hazard class
Based on the available data, the product does not contain substances listed in the main European lists of potential or suspected endocrine disruptors with
human health effects under evaluation.
12.1. Toxicity
PROPAN-2-OL
LC50 - for Fish > 100 mg/l/96h Pimephales promelas
EC50 - for Crustacea > 100 mg/l/48h Daphnia magna
EC50 - for Algae / Aquatic Plants > 100 mg/l/72h Scenedesmus quadricauda
N-acetilcaprolattame
LC50 - for Fish > 1000 mg/l/96h Salmo gairdneri
TRIETHYLAMINE
LC50 - for Fish 43,7 mg/l/96h Pimephales promelas - Cavedano americano
EC50 - for Crustacea 200 mg/l/48h Daphnia magna - Pulce d'acqua grande
Chronic NOEC for Fish 320 mg/l Danio rerio - pesce zebra
PROPAN-2-OL
Rapidly degradable
N-acetilcaprolattame
Rapidly degradable
TRIETHYLAMINE
Solubility in water > 10000 mg/l
Rapidly degradable
PROPAN-2-OL
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TRIETHYLAMINE
Partition coefficient: n-octanol/water 1,45
BCF < 0,5
TRIETHYLAMINE
Partition coefficient: soil/water 2,57
Based on the available data, the product does not contain substances listed in the main European lists of potential or suspected endocrine disruptors with
environmental effects under evaluation.
Reuse, when possible. Product residues should be considered special hazardous waste. The hazard level of waste containing this product should be
evaluated according to applicable regulations.
Disposal must be performed through an authorised waste management firm, in compliance with national and local regulations.
CONTAMINATED PACKAGING
Contaminated packaging must be recovered or disposed of in compliance with national waste management regulations.
The product is not dangerous under current provisions of the Code of International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID), of
the International Maritime Dangerous Goods Code (IMDG), and of the International Air Transport Association (IATA) regulations.
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15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
Restrictions relating to the product or contained substances pursuant to Annex XVII to EC Regulation 1907/2006
Product
Point 40
Contained substance
Point 75
Regulation (EC) No. 2019/1148 - on the marketing and use of explosives precursors
Not applicable
Healthcare controls
Workers exposed to this chemical agent must not undergo health checks, provided that available risk-assessment data prove that the risks related to the
workers' health and safety are modest and that the 98/24/EC directive is respected.
A chemical safety assessment has not been performed for the preparation/for the substances indicated in section 3.
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LEGEND:
- ADR: European Agreement concerning the carriage of Dangerous goods by Road
- ATE: Acute Toxicity Estimate
- CAS NUMBER: Chemical Abstract Service Number
- CE50: Effective concentration (required to induce a 50% effect)
- CE NUMBER: Identifier in ESIS (European archive of existing substances)
- CLP: EC Regulation 1272/2008
- DNEL: Derived No Effect Level
- EmS: Emergency Schedule
- GHS: Globally Harmonized System of classification and labeling of chemicals
- IATA DGR: International Air Transport Association Dangerous Goods Regulation
- IC50: Immobilization Concentration 50%
- IMDG: International Maritime Code for dangerous goods
- IMO: International Maritime Organization
- INDEX NUMBER: Identifier in Annex VI of CLP
- LC50: Lethal Concentration 50%
- LD50: Lethal dose 50%
- OEL: Occupational Exposure Level
- PBT: Persistent bioaccumulative and toxic as REACH Regulation
- PEC: Predicted environmental Concentration
- PEL: Predicted exposure level
- PNEC: Predicted no effect concentration
- REACH: EC Regulation 1907/2006
- RID: Regulation concerning the international transport of dangerous goods by train
- TLV: Threshold Limit Value
- TLV CEILING: Concentration that should not be exceeded during any time of occupational exposure.
- TWA: Time-weighted average exposure limit
- TWA STEL: Short-term exposure limit
- VOC: Volatile organic Compounds
- vPvB: Very Persistent and very Bioaccumulative as for REACH Regulation
- WGK: Water hazard classes (German).
GENERAL BIBLIOGRAPHY
1. Regulation (EC) 1907/2006 (REACH) of the European Parliament
2. Regulation (EC) 1272/2008 (CLP) of the European Parliament
3. Regulation (EU) 2020/878 (II Annex of REACH Regulation)
Revision nr. 1
ADRANOX SRL
Dated 07/10/2021
First compilation
Printed on 07/10/2021
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